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5 Cool things you never knew about Elmer's Glue

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What the Brexit means for your retirement

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11:51 am Stemline Therapeutics presents SL-401 lead-in data from its ongoing Phase 2 trial in acute myeloid leukemia in remission with minimal residual disease and ongoing Phase 2 trial in high-risk myeloproliferative neoplasms at the ASH Annual Meeting (STML) :

  • SL-401 was found to be safe and well tolerated, and side effects were predictable and manageable. The lead-in dose escalation stages of both Phase 2 studies (3 x 3 design) were completed without dose limiting toxicity (:DLT) and a maximum tolerated dose (MTD) was not reached in either study (n=9 patients in AML/MRD lead-in; n=9 patients in MPN lead-in). 12 ug/kg/day was the highest tested dose in both studies and is currently the dose level being used in the expansion stage of both studies.
  • Andrew A. Lane, M.D., Ph.D., lead author on the AML study, commented, "Given the unacceptably high relapse rates seen in AML, MRD has emerged as an important predictor of relapse with CD123 as a key target for therapy. The preliminary results seen with SL-401 in this setting are promising. We look forward to enrolling patients in the expansion stage of the trial as we continue to optimize and refine methods to assess and follow MRD."
  • Mrinal S. Patnaik, M.D., lead author on the MPN study, noted, "The early data from the dose escalation portion of the trial suggests SL-401 can be dosed safely in this patient population. Additionally, we are observing encouraging signs of clinical activity in several patients. We look forward to enrolling patients in the expansion stage of the trial."

11:35 am Boeing issues statement regarding the Air Force One program (BA) : "We are currently under contract for $170 million to help determine the capabilities of these complex military aircraft that serve the unique requirements of the President of the United States. We look forward to working with the U.S. Air Force on subsequent phases of the program allowing us to deliver the best planes for the President at the best value for the American taxpayer."

11:34 am Gain Capital responds to the UK's FCA consultation paper (GCAP) :

The co notes the FCA's consultation paper issued today (CP 16/40 - Enhancing conduct of business rules for firms providing contract for difference products to retail clients).

  • "GAIN is in favor of measures that enhance consumer protection in the FX/CFD market. The Company in particular supports all measures to curb aggressive marketing to inexperienced investors and to ensure all clients fully understand the risks of FX/CFD trading...Several of the other changes proposed by the FCA are consistent with GAIN Capital's current practices and should not require significant changes to its operations. The Company does not offer any binary trading products. GAIN also notes the FCA has proposed a timeline of March 7, 2017 to consider these new rules and looks forward to working closely with the FCA in the coming months."

11:12 am Currency Commentary: DXY Testing 100 Before ECB (:SUMRX) :

  • The Dollar Index is testing the 100 level for support. The DXY has seen its recent rally cool and has rolled back to test the key level. Economic data in the U.S. remains strong with Unit Labor and Productivity revisions mixed, Factory Orders beating expectations, and a shortfall on the Trade Balance deficit. The Trade Balance will be of interest moving forward as the data moving forward will reflect the strengthening of the greenback.
  • The euro remains the top story in the currency markets as we prepare for the Thursday ECB decision and press conference by President Mario Draghi. The central bank is not expected to move on rates which will bring the Draghi comments front and center. The ECB is expected to address its 2017 outlook for its bond purchase program which will be of great interest. Early expectations are for the ECB to expand its purchase program plans past March of 2017 but there is also some worries that Mr. Draghi will look to signal an eventual end to this program. As we saw, starting in May of 2013 with then-Fed Chair Ben Bernanke, tapering can be a very difficult process to signal. Mr. Draghi has been brilliant at verbal signals in the past but this will represent his most difficult challenge. The euro has been holding steady at 1.07 ahead of the meeting.
  • The pound has been able to hold on to the 1.27 area. Minutes from the last Bank of England meeting were released to little fanfare this morning. The focus remains on the Brexit process. Early on, there is a lot of fear over a difficult process but the rally in sterling over the past month suggests some investors are betting on an smoother transition.
  • The yen has moved into the 113 area. Yen was able to find support at 115 following a 10% decline in the weeks after the election. Now we are seeing it float slightly higher. But the downward trend is still in place at the moment and 115 should continue to play a key role (BONDX, FOREX).

11:06 am Notable movers of interest: CMG -7% on management concerns regarding FY17 guidance (SCANX) :

The following are some of today's most notable movers of interest, categorized by market capitalization (large cap over $10 billion and mid cap between $2-10 billion) and ranked by % change (all stocks over 100K average daily volume).

Large Cap Gainers

  • RBS (5.3 +5.37%): Confirms majority settlement in litigation of claimants in 2008 Shareholder Rights Issue.
  • NFLX (122.06 +2.43%): Upgraded to Hold from Sell at Evercore ISI. 

Large Cap Losers

  • CMG (368.38 -7.04%): Shares fall after management expresses concerns about about FY17 guidance at Barclays conference.
  • TEVA (34.66 -6.43%): Names Dipankar Bhattacharjee as President and CEO, Global Generic Medicines Group, effective today; reaffirms FY16 forecast. 

Mid Cap Gainers

  • AMD (9.14 +5.3%): Shares higher following Tweaktown report that its Radeon GPU might power Intel's (INTC) GPUs. 
  • BLUE (75.45 +4.57%): Provides updates on HSC gene therapy programs; confirms two-to-threefold increase in vector copy numbers observed in retrospective in vitro analyses. 

Mid Cap Losers

  • SNCR (43.78 -10.65%): Acquires IntraLinks Holdings (IL) for $13.00/share in cash, or approximately $821 mln.
  • JUNO (18.97 -7.1%): Downgraded to Mkt Perform from Outperform at Raymond James. 

11:01 am Magna announces it has won multiple new seating programs from the BMW Group (BMWYY); financial details not disclosed (MGA) :

  • The seating programs for the BMW Group will be will be supplied from a new, state-of-the-art seat manufacturing facility in Spartanburg County, South Carolina.
  • Magna's new seating plant is expected to be operational in June 2017 and could employ up to 480 people by 2020. The facility will feature dedicated assembly and sequencing lines to supply seats for various BMW models at the BMW Group's nearby assembly plant.
  • "This is a new chapter in the ongoing collaboration between Magna and the BMW Group, as it's our first seating business award with this valued global customer," said Mike Bisson, president of Magna Seating. "With this investment and job creation we are extremely pleased to join the growing automotive industry in South Carolina."

10:47 am Bob Evans: Sandell Asset (8.1% shareholder) says encouraged by JPMorgan financial advisors news; does not intend to pursue consent solicitation (BOBE) : Sandell says "We are encouraged by the recent revelation in the Company's FY2017 Second Quarter Earnings Release dated December 5, 2016 that the Board of Bob Evans 'is working with J.P. Morgan to review and evaluate potential opportunities for value creation" and "continues to evaluate all options to create shareholder value.' Until this point, the Company had not disclosed matters as basic as the identity of its financial advisors, leading to a great deal of skepticism on the part of many members of the investment community as to the Company's commitment to enhance shareholder value... As a result, Sandell does not at this time intend to pursue a consent solicitation seeking shareholder approval of a precatory proposal advocating increased transparency."

10:45 am Transocean Partners unitholders approve merger with Transocean (RIG); deal expected to close on or around Dec 9 (RIGP) :  

10:37 am AbbVie announces positive results from a Phase 2 study evaluating IMBRUVICA in patients with chronic graft-versus-host-disease (ABBV) :

The study found ibrutinib demonstrated efficacy, sustained responses and reduced symptom severity, with an overall response rate (:ORR) of 67%.

  • At a median follow-up of 14 months in 42 patients, the study found an ORR of 67%. One-third of all responders achieved a complete response (CR). In addition, 71% of patients showed a sustained response of at least 5 months. Similar response rates were seen across all involved organs, and patients with multiple organ involvement generally responded in multiple organs. Over the course of the study, 61% of responders experienced a clinically meaningful improvement in symptoms, as measured by at least a 7-point decrease in Lee Symptom Scale score. In addition, 62% of all patients were able to reduce steroid dose to an acceptable minimal level and five completely discontinued steroids with response. Twelve patients (29%) remain on treatment with ibrutinib.
  • IMBRUVICA, a first-in-class Bruton's tyrosine kinase (:BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech (JNJ)

10:36 am CTI BioPharma announces the PERSIST-2 Phase 3 study of pacritinib vs best available therapy shows 'encouraging' clinical activity in high-risk patients with advanced myelofibrosis in late-breaking session at ASH Annual Meeting (CTIC) :

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R.

  • Data presented at ASH show that in myelofibrosis patients a statistically significant response rate in spleen volume reduction with pacritinib therapy was observed compared to BAT that included use of the approved JAK1/JAK2 inhibitor ruxolitinib. The co-primary endpoint of reduction of Total Symptom Score was not achieved but trended toward improvement in TSS. Irrespective of prior ruxolitinib treatment, pacritinib therapy resulted in a statistically significant higher proportion of patients with SVR than patients on BAT.
  • Clinical studies for pacritinib are currently subject to a full clinical hold issued by the FDA in Feb 2016. At the time, the FDA noted interim overall survival results from the PERSIST-2 showing a detrimental effect on survival were consistent with the results from PERSIST-1. Two hundred twenty-one patients were enrolled at least 24 weeks prior to the full clinical hold and were potentially evaluable for the Week 24 efficacy endpoint. In the ITT efficacy population at study entry, 46 percent of patients had platelet counts less than 50,000 per microliter and 59 percent were anemic. Normal platelet counts range from 150,000 to 450,000 per microliter. The percentage of patients in the ITT efficacy population who received prior ruxolitinib was as follows: 41 percent pacritinib QD; 42 percent pacritinib BID; and 46 percent BAT.

10:35 am Wi-LAN acquires a portfolio of patents from Eastman Kodak (KODK); terms not disclosed (WILN) : The portfolio covers various elements of electrophotography and other printing technologies with broad geographic coverage across numerous countries, including the US, Germany, Japan and China.

10:30 am Kite Pharma presents results from the ZUMA-1 trial of axicabtagene ciloleucel in patients with chemorefractory aggressive non-Hodgkin lymphoma that met the primary endpoint at ASH 2016 (KITE) :

Co states, "We are encouraged by the high rate of complete remissions in this group and look forward to presenting longer follow-up at the primary analysis in the first quarter 2017."

  • ZUMA-1 met the primary endpoint of objective response rate (:ORR), p
  • The primary analysis of ZUMA-1 will include a minimum of 6 months of follow-up. Kite intends to seek regulatory approval of axicabtagene ciloleucel in refractory aggressive NHL and plans to complete its rolling submission of the Biologics License Application (:BLA) in the first quarter of 2017.

10:25 am Hanover Insurance increases quarterly dividend to $0.50/share from $0.46/share (THG) :  

10:17 am Allegiance Bancshares appoints Paul P. Egge as CFO effective December 19 (ABTX) : Most recently, Mr. Egge served as Senior Vice President, Director of Capital Planning and Corporate Development at Cadence Bank

10:15 am Sirius XM Radio works w/ AT&T (T) to provide 4G LTE connectivity to support SiriusXM Guardian in select 2017 model year FCA (FCAU) vehicles (SIRI) :  

10:02 am OCI Partners confirms receipt of buyout offer from OCI N.V. (shares halted) (OCIP) : The proposed transaction is subject to the negotiation and execution of a definitive agreement and approval of such definitive agreement and transactions contemplated thereunder by the board of directors of OCI N.V., the board of directors of the general partner of OCI Partners and a Conflicts Committee to be established by the OCIP Board, and would be subject to customary closing conditions.

10:01 am Verizon UBS Global Media & Communications Conference Notes (VZ) :

  • Market is moving towards skinny bundles.
  • Last year data traffic grew 45%.
  • AOL transaction continues to perform, up 10% in revenue in the last quarter.
  • Yahoo is doing all their work on the data breach.
  • More bullish on digital media b/c millennials aren't buying 300 channel bundles, seem more internet oriented.
    • Investing in things that resonate with younger group, b/c that's where co sees the opportunities.
  • Pillars for co moving forward: Sports, finance, news, and entertainment.
  • Respects AT&T Time Warner strategy, believes merger makes perfect sense.

9:45 am Safe Bulkers prices 13,600,000 offering at $1.10/share (SB) : The Company plans to use the net proceeds of the offering for the acquisition of secondhand vessels, capital expenditures and for other general corporate purposes, which may include repayment or settlement of its financial obligations.

9:42 am Toll Brothers (TOL +3%) leading homebuilders (ITB +0.6%) higher after strong report (call at 11) (TOL) : TOL +2.99% BZH +1.94% MHO +1.90% KBH +1.49% HOV +1.30% PHM +1.23% TPH +1.11% LEN +1.11% CAA +0.98% TMHC +0.94% MTH +0.84% ITB +0.77% CCS +0.49% WLH +0.44%

9:39 am Chipotle Mexican Grill sinks -7% down to a fresh 5-week low under $370-level after management expressed concerns about FY17 guidance. (CMG) : Next area of interest below lies near the early November lows around 360/353.

9:38 am Opening Market Summary: Monday's Laggards Display Early Strength (:WRAPX) :

The major averages began the trading day near their flat lines with losses in three cyclical sectors exerting pressure on the market. The S&P 500 hovers near its flat line.

Six of eleven sectors hold gains with yesterday's laggards like real estate (+0.6%), telecom services (+0.4%), and consumer staples (+0.3%) in the lead. On the flip side, industrials (-0.2%) and materials (-0.2%) hover just below their flat lines while energy (-0.9%) has been pressured by a 2.7% decline in crude oil, which has slid to $50.39/bbl.

Treasuries have inched up off their recent levels, pressuring the 10-yr yield one basis point to 2.38%.

9:36 am Airlines, real estate, banks, cybersecurity, homebuilders strong out the gate with energy and retail lagging vs. SPY -0.04% (SPY) : JETS +1.18% XLRE +0.83% IYR +0.71% KBE +0.65% HACK +0.57% ITB +0.55% KRE +0.52% SLV +0.41% IBB +0.21%... OIH -1.37% USO -1.28% XOP -1.04% XLE -0.84% XRT -0.41% XLI -0.21%

9:29 am On The Wires (:WIRES) :

  • Coronal Energy, powered by Panasonic (PCRFY), announces plans to substantially increase the number of solar PV projects it will acquire in 2017 and 2018. The ambitious program will support a rapidly expanding solar pipeline in North America that already totals over three gigawatts under development.
  • RLJ Lodging Trust (RLJ) announces that it has sold two hotels in New York City for $286 million or $494,500 per key. Separately, the Company sold one other hotel in Bakersfield, CA for $13 million.
  • Xplore Technologies (XPLR) announces that one of the nation's top 10 electric power and natural gas utility companies has placed a $1.7 million follow-on order for XSLATE B10 fully rugged tablets, bringing the customer's total investment in Xplore solutions to more than $2.7 million in 2016. This is the second follow-on order placed by the customer this year as part of an ongoing, multi-year initiative by the customer to increase the mobility of its field service operations and achieve new cost savings across its utility operations. Xplore continues to work closely with the customer to further expand its implementation of rugged tablets through additional orders.
  • SEI (SEIC) UK Private Banking today announced that it has extended its contract with Veritas Investment Management LLP (Veritas) for an additional three years. As a result, SEI has now secured contract extensions with all of its current SEI Wealth PlatformSM (the Platform) UK clients.
  • L-3 Communications (LLL) announces that it will change its name to L3 Technologies effective December 31, 2016. The new name capitalizes on L-3's strong brand equity, while better reflecting the Company's evolution into a leading global provider of a broad range of technology solutions. As part of its name change, L-3 will update its corporate logo and change its email and website to L3T.com on January 3, 2017. The Company's New York Stock Exchange ticker symbol will remain the same.
  • Mast Therapeutics (MSTX) reports that the first patient has been enrolled in an investigator-sponsored Phase 2 study of the Company's lead product candidate, AIR001, for the treatment of heart failure with preserved ejection fraction (HFpEF). The Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training (INABLE-TRAINING) in HFpEF study will evaluate AIR001's potential to improve the clinical responses to exercise training in individuals with HFpEF. The INABLE-TRAINING study is expected to enroll approximately 68 patients who will undergo 12 weeks of cardiac rehabilitation. The primary endpoint of the study will be the change in exercise capacity as measured by peak oxygen consumption.
  • Teva Pharmaceutical (TEVA) commented that its preliminary financial outlook for 2017, which was presented in July 2016, is not being updated until the company publicly announces updated guidance, which is expected to be in January 2017, as indicated in yesterday's press release.

9:19 am National Retail Properties prices $350 mln of 3.60% senior unsecured notes due 2026 at 98.897% of the principal amount with a yield to maturity of 3.733% (NNN) : Co intends to use the net proceeds from the offering to repay all of the outstanding indebtedness under its credit facility. In addition, the Company intends to use the remainder of the net proceeds from this offering to fund future property acquisitions and for general corporate purposes.

9:14 am Southside Banc prices an upsized common stock offering of 1.9 mln shares at $36.50/share for gross proceeds of about $69.4 mln (SBSI) :

  • The offering was upsized from $60 mln. The co intends to use the net proceeds from the offering, including any net proceeds from the underwriter's exercise of its option to purchase additional shares, for general corporate purposes, including potential future acquisitions and to support organic growth.
  • The co has granted the underwriter a 30-day option to purchase up to an additional 285,000 shares of Company common stock.

9:14 am S&P futures vs fair value: +3.50. Nasdaq futures vs fair value: +11.30. (:WRAPX) :

The stock market is on track for a modestly higher open as futures on the S&P 500 trade four points above fair value.

Index futures crept higher in overnight action, alongside modest gains in Asia. European markets have also flashed some strength this morning, led by Italy's MIB (+2.0%). The upbeat sentiment comes even though political uncertainty in Italy has increased due to the results of the weekend referendum.

The advance in U.S. futures and European markets has masked some selling in the commodity space. WTI crude began retreating immediately after yesterday's pit close and it is currently lower by 2.4% at $50.56/bbl.

On the corporate front, Toll Brothers (TOL 31.65, +1.18) holds a pre-market gain of 3.9% after beating revenue estimates on earnings that may not compare to estimates. Another discretionary component, Autozone (AZO 784.95, +8.53) is set to begin higher by 1.1% after beating earnings expectations.

Also of note, Chipotle Mexican Grill (CMG 381.05, -15.22) is down 3.8% after the company's management expressed worries about guidance for fiscal year 2017.

Treasuries are little changed with the 10-yr yield down one basis point at 2.39%.

9:14 am AT&T UBS Annual Global Media and Communications Conference Notes (T) :

  • Will be in front of the Senate Judiciary tomorrow at 10am ET to discuss AT&T Time Warner (TWX) merger.
  • On the new Trump Administration and the effect on AT&T
    • Co is hopeful of a moderate approach to regulations from the Trump administration
    • Very enthusiastic about Trump's corporate Tax reform plans.
  • Underlying industry trends and DirecTV Now
    • Believes this is the golden age of TV, and that people are underestimating premium long-term content.
      • Co made the deal with DirecTV for access to premium long-term content. 
    • Lowest content cost in the industry due to DirecTV acquisition.  
    • If you are a DirecTV customer, you are able to stream all of your content to your mobile device, including what is on your DVR.
    • Very little capital required to launch service.
    • By year end, half of Direct TV customers will be engaged in over-the-top (:OTT)
      • This is important, because co will be able to have very unique viewership data, which creates significant advertising opportunities.
    • Co has high expectations for churn reductions in the environment. 
  • The Time Warner acquisition
    • Classic vertical merger
    • Believes it is a clean deal and thinks review process should be straight forward. 
    • Co doesn't know if they will assume any licensesfrom Time Warner, which if assumed, will require an SEC review.

AT&T shares are flat pre-market

9:06 am Buffalo Wild Wings activist Marcato sends letter to Franchisees outlining the ways in which Marcato's roadmap for change and value creation at the Co can benefit franchisees' businesses and the Buffalo Wild Wings brand (BWLD) :

Highlights from the letter:

  • "We strongly believe that the future strength of Buffalo Wild Wings will be best realized through a return to a majority-franchised model, in which serving the needs of franchisees will be the key to growth and innovation. Under our proposal, Buffalo Wild Wings would adopt a franchisee-first approach"
    • "Franchising will be the top priority of the business, and the franchisor will no longer be conflicted by aspirations of company-operated unit expansion."
    • "Guest initiatives and related investments such as tablet order and pay, Guest Experience Captains, and loyalty programs will be vetted for franchisee feedback, ROIC analysis, and business improvement. Initiatives that do not deliver measurable and compelling results should not be rolled out."
    • "Franchisees will receive equal and immediate access to new systems, tools, marketing initiatives, and operational improvements that are proven at company-operated units."
    • "The result will be a franchisee-oriented corporate partner, with a leaner structure that can be more responsive to your needs". 
  • "New unit development has been constrained due to ever-increasing capital costs and pre-opening expenses, which have reduced the number of potential locations that can achieve the volumes to justify the required investment. Our plan would initiate a value-engineering review to reduce the costs of new unit development, improve ROIC, and expand the addressable market for BWW franchisee units."
  • "The Company has retained many choice "greenfield" markets in high-AUV regions, such as California, Florida, Texas, and Washington, D.C., for its own development, effectively capping the growth opportunities available to existing franchisees and deterring investments from new entrants." 
  • "The Board of Directors must include directors with real restaurant operating experience; with the financial acumen to appropriately evaluate the business considerations of BWW's brand and strategy development; and with an appreciation for the importance of a healthy and prosperous franchise system."

9:06 am Digi Intl: Belden (BDC) sends additional letter to the Board of Digi International reiterating its offer to acquire it for $13.82/share in cash (DGII) : "Since the release of the prior letter on November 11, Digi's management and Board of Directors have remained unwilling to respond or engage in discussions with Belden, despite repeated attempts at outreach. Belden believes that Digi's lack of engagement is to the detriment of Digi's shareholders. Belden believes this proposal to be a full and fair offer, represents a unique opportunity for Digi's shareholders to receive substantial and immediate value that recognizes Digi's strategic worth to Belden, and reflects a significant premium to the value that Digi could achieve on a standalone basis. Belden remains committed to bringing the two companies together and would prefer to execute a negotiated transaction. If Digi continues to ignore Belden's requests for a meeting and/or refuse to engage in any discussions, Belden is prepared to pursue alternative paths to complete a transaction. .....Belden is prepared to meet with Digi immediately to work toward a successful completion of the proposed transaction, and Belden looks forward to working with Digi's management team and Board of Directors to maximize value for all stakeholders. Although there can be no assurances a definitive agreement will be reached between the companies, Belden is committed to pursuing this transaction and will continue to update shareholders as the situation proceeds."

9:04 am Forest City Enterprises' Board will recommend shareholders approve a proposal to eliminate its current dual-class share structure and announces Scopia Capital will vote its shares in favor of co's nominees (FCE.A) :

Under the terms of the proposed reclassification, all of the outstanding shares of the Company's Class B Common Stock would be converted into shares of the Company's Class A Common Stock, and holders of Class B shares will exchange each of their Class B shares for 1.31 shares of Class A Common Stock.

  • In connection with the reclassification, RMS, Limited Partnership ("RMS"), the controlling shareholder of the Company's Class B shares, has agreed to vote all shares of Class B shares owned by it in favor of the proposal, representing a majority of the Class B shares outstanding.

In connection with today's announcement, the Company also announced an agreement with Scopia Capital Management, a long-term Forest City shareholder.

  • Under the terms of the agreement, Scopia has agreed, among other things, to vote its shares in favor of each of the Forest City Board's nominees at the Company's 2017 Annual Meeting of Shareholders and to vote in favor of the reclassification proposal.

9:04 am First NBC Bank discloses leadership transition plan, will separate the roles of Chief Executive Officer and President (FNBC) :

The co announced a leadership transition plan designed to strengthen the company's operations and to best position First NBC for the future. As part of its ongoing review of management and internal controls, the First NBC Board of Directors has announced its intent, subject to regulatory approvals, to:

  • Separate the roles of Chief Executive Officer and President, with Ashton J. Ryan Jr. continuing as President and a member of the Boards of Directors of First NBC Bank and First NBC Bank Holding Company
  • Appoint Hermann "Buck" Moyse, III, as Interim Chief Executive Officer of First NBC Bank and First NBC Bank Holding Company
  • Appoint Marsha S. Crowle as Interim Chief Operating Officer of First NBC Bank and First NBC Bank Holding Company. Ms. Crowle will continue to serve as Chief Compliance Officer.

First NBC has a comprehensive search process underway to identify a permanent Chief Executive Officer and Chief Operating Officer. The search process is led by the Board's recently formed Structural and Organizational Committee. First NBC has retained Chrisman & Company, a leading executive search firm, to assist in the process.

  • As previously announced, First NBC's Board of Directors is actively pursuing strategic options to deliver enhanced shareholder value. First NBC does not intend to comment further unless and until a definitive transaction is achieved.

9:02 am Atwood Oceanics announces agreement with Daewoo Shipbuilding & marine Engineering Co to delay the delivery of 2 newbuild ultra-deepwater drillships by 2 years (ATW) :

  • In connection with the delay, Atwood will make a payment of $125 mln for the Atwood Archer on or before Dec 15, 2016, as well as a payment of $15 mln on the earlier of June 30, 2018 or the delivery date. In respect of the Atwood Admiral, Atwood will make a payment of $10 mln on the earlier of September 30, 2017 or the delivery date. DSME will extend all remaining milestone payments, which include $83.9 mln plus fees and interest for the Atwood Admiral and $165.0 mln plus fees and interest for the Atwood Archer, until Dec 30, 2022.
  • "Our liquidity position is enhanced by approximately $250 mln from June 30, 2018 until final payments are made to DSME on December 30, 2022. This lengthened time for making final milestone payments represents a staggering of our debt maturities. Following the December 15, 2016 payment, all interest expenses on the outstanding amounts due to DSME will be accrued and paid at the time of the final milestone payment, improving our free cash flows through 2022."

9:01 am Calithera Biosciences presents clinical data from CB-839 at SABCS; data 'demonstrates' the clinical activity, tolerability, & mechanism of action of CB-839 in patients with advanced/metastatic triple negative breast cancer (CALA) :

  • Most patients had received prior taxane therapy in either the neo-adjuvant or metastatic setting. Among evaluable patients treated with CB-839 doses of at least 600 mg bid, there are 5 partial responses and disease control in 11 patients. In addition, the combination overcomes resistance to paclitaxel in heavily pretreated TNBC patients. There is a 38% response rate and 50% disease control rate in patients who received prior taxanes in the metastatic setting. There is a 50% response rate among taxane-refractory African American patients, consistent with higher glutamine utilization observed in tumors from this population.
  • The combination of CB-839 and paclitaxel has been well tolerated to date, with adverse events that have been easily manageable and reversible, including several paclitaxel related toxicities. There was one case of dose-limiting, recurrent grade 3 neutropenia at the 400 mg dose level, which led to a reduction in the dose of paclitaxel for that patient. The most frequent adverse event = Grade 3 is neutropenia.

9:01 am Nucor has agreed to acquire Southland Tube, an independent manufacturer of hollow structural section steel tubing, for $130 million (NUE) :

HSS is used in a broad array of structural and mechanical applications including nonresidential construction, infrastructure, and heavy equipment end-use markets.

  • In 2006, 8% of Nucor's total steel mill shipments were to our downstream businesses.
    • Co expects that number to grow to about 20% with these acquisitions.

9:00 am Teledyne Tech acquires Hanson Research; terms not disclosed (TDY) : Hanson Research 'specializes' in analytical instrumentation for the pharmaceutical industry.

8:59 am On The Wires (:WIRES) :

  • WPCS International Incorporated (WPCS) announces $2.6 million in new contracts during November 2016.
  • Ultratech (UTEK) announces that the Laboratory for Emerging and Exploratory Devices has chosen the Ultratech-CNT Fiji G2 PEALD system as its instrument of choice for its research activities. Professor Salahuddin was recently honored at the White House by President Barack Obama for his work in developing nano-scale electronic and spintronic devices for low power logic and memory applications.
  • Ignite Restaurant Group (IRG) announces that Debra Eybers has been named Interim Chief Operating Officer, effective November 29, 2016 and Lou Anne Banks joined the company as Vice President of Marketing on October 17, 2016. Robert S. Merritt, Chief Executive Officer of Ignite Restaurant Group, stated, "We are excited to have Deb and Lou Anne join the Ignite team. They both bring a wealth of industry experience that will be instrumental in our future success. We look forward to working with Deb and Lou Anne as they help lead two important areas of focus for our company."

8:59 am Ring Energy prices 6.525 mln common stock offering at $11.50/share (REI) :  

8:57 am S&P futures vs fair value: +3.50. Nasdaq futures vs fair value: +10.10. (:WRAPX) :

The S&P futures trade four points above fair value.

Equity indices in the Asia-Pacific region ended Tuesday on a higher note. Press reports from Japan indicated the country may issue mid-year deficit bonds, marking the first such issue since 2009. The Reserve Bank of Australia kept its key interest rate at 1.5%, as expected. The People's Bank of China strengthened the yuan fix to mid-November levels.

  • In economic data:
    • Japan's Average Cash Earnings +0.1% year-over-year (consensus 0.2%; last 0.0%) and October Overtime Pay -1.4% year-over-year (last -1.3%)
    • Australia's Q3 Current Account deficit narrowed to AUD11.40 billion from AUD15.90 billion (expected deficit of AUD13.70 billion)

---Equity Markets---

  • Japan's Nikkei added 0.5% with seven sectors ending in the green. Utilities (+2.3%), materials (+1.9%), and financials (+1.7%) outperformed while consumer staples (-0.6%) and health care (-0.4%) lagged. SUMCO, Kobe Steel, Mitsubishi Materials, Casio Computer, Isuzu Motors, and Panasonic gained between 2.8% and 5.5%.
  • Hong Kong's Hang Seng climbed 0.8% with financials ending among the leaders. China Life Insurance, HSBC, ICBC, BoC Hong Kong, Bank of China, and Hang Seng Bank gained between 1.1% and 3.6%.
  • China's Shanghai Composite shed 0.2%. China Eastern Airlines fell 3.0% while Aluminum Corp of China, Jiangxi Copper, Orient International, and China Sports Industry Group lost between 3.0% and 4.2%.
  • India's Sensex added 0.2%. Housing Development Finance gained 2.1% while Tata Steel, SBI, Reliance Industries, Infosys, and Wipro gained between 0.6% and 1.2%. Hindustan Unilever was the weakest performer, falling 1.2%.

Major European indices trade in the green with Italy's MIB (+1.7%) showing relative strength. According to the Italian Interior Ministry, the country is on track for an election in February. Prime Minister Matteo Renzi agreed to delay his resignation until a budget for next year is passed. With the main focus on Italy, participants may have overlooked yesterday's Eurogroup meeting on Greece. It is not yet known whether the International Monetary Fund will take part in the Greek bailout after expressing concerns about insufficient debt relief included in the deal.

  • In economic data:
    • Eurozone Q3 GDP +0.3% quarter-over-quarter, as expected (last 0.3%); +1.7% year-over-year (consensus 1.6%; last 1.6%). Retail PMI held at 48.6.
    • Germany's October Factory Orders +4.9% month-over-month (expected 0.6%; last -0.3%)
    • Swiss November CPI -0.2% month-over-month (expected -0.1%; last 0.1%); -0.3% year-over-year (consensus -0.2%; last -0.2%)

---Equity Markets---

  • Germany's DAX is higher by 0.3% with utilities and financials among the leaders. E.On, RWE, Deutsche Bank, and Commerzbank are up between 1.4% and 5.3%. On the downside, Linde, Henkel, and Siemens are all down near 0.8%.
  • UK's FTSE trades up 0.2% with financials contributing to the advance. HSBC, RBS, Land Securities, British Land Company, Intu Properties, and Barclays hold gains between 1.4% and 3.3%. Miners are on the defensive with Anglo American, BHP Billiton, Rio Tinto, and Glencore down between 1.5% and 3.7%.
  • France's CAC has climbed 0.6%. Financials Societe Generale, BNP Paribas, and Credit Agricole are among the leaders with gains between 1.0% and 5.0%. On the downside, energy names Total and Technip are both down near 0.7% while Airbus and Valeo show respective losses of 1.1% and 1.6%.
  • Italy's MIB is higher by 1.7%. Financials like Mediobanca, UBI Banca, Intesa Sanpaolo, Unicredit, and Banca Pop Emilia Romagna are up between 2.0% and 6.2%.

8:48 am Gapping down (SCANX) :

Gapping down
In reaction to disappointing earnings/guidance
: MIK -10.1%, IRTC -3.6%

Select metals/mining stocks trading lower: BBL -2.9%, BHP -2.8%, MT -2.1%, GFI -1.9%, RIO -1.8%, AA -1.5%, X -1.4%, FCX -1.4%, VALE -1.3%, CLF -1.2%

Select oil/gas related names showing early weakness: EPE -2.1%, SDRL -1.9%, DNR -1.8%, WLL -1.3%, MRO -1.1%

Other news:

  • RGSE -25.5% (public offering of common stock & series I warrants to purchase shares of common stock; size not disclosed )
  • SGY -15.6% (provides operational update for its Amethyst well; no assurance well can be restored to previous levels)
  • SB -14.8% ( to offer Common Stock)
  • LXRX -8.6% (announces top-line results today from a Phase 2 clinical study of sotagliflozin conducted by Lexicon in collaboration with JDRF)
  • RCII -7.7% ( CFO Guy J. Constant resigns; also downgraded to Hold from Buy at Deutsche Bank )
  • FET -6% (prices 7 mln shares of common stock by co and selling shareholders at a price to the public of $21.50 per share)
  • TEVA -4.4% ( names Dipankar Bhattacharjee as President and CEO, Global Generic Medicines Group, effective today; reaffirms FY16 forecast)
  • ASUR -4.2% (prices underwritten public offering of 1,695,000 newly issued shares of common stock at $8.00/share)
  • CMG -3.9% (mgmt says it is nervous about FY17 guidance at Barclays Conf)
  • SBSI -3.8% (announces an underwritten public offering of approx. $60 mln of its common stock )
  • STWD -3.6% (prices 17.8 mln shares of common stock for gross proceeds of $394.3 mln)
  • REI -2.9% (to offer shares of its common stock )
  • SIEN -2.8% ( confirms receipt of FDA pre-market supplement approval for four new breast implant styles in both shaped and round as well as additional profile and sizing options for nine existing implant offerings)
  • MTDR -2.6% (prices 6,000,000 shares at $24.65/share)
  • ZG -1.5% (proposes offering of $400 mln of convertible senior notes due 2021)

Analyst comments:

  • OSK -1.1% (downgraded to Neutral from Buy at Longbow)
  • SPWR -1% (downgraded to Neutral from Buy at Guggenheim)
  • SKYW -1% (downgraded to Hold from Buy at Evercore ISI)
  • NKE -0.8% (downgraded to Market Perform from Outperform at Cowen)

8:46 am Bristol-Myers announces updated results for Opdivo monotherapy and in combination with Yervoy in previously treated small cell lung cancer at World Conference on Lung Cancer (BMY) : The confirmed objective response rate (primary objective) was 25% (95% CI: 15, 37) in patients who received Opdivo plus Yervoy and was 11% (95% CI: 6, 19) with Opdivo alone with additional follow-up. Response was observed regardless of platinum sensitivity or prior lines of therapy. With the combination, three patients experienced a complete response. The estimated two-year overall survival rate (secondary objective) was 30% with Opdivo plus Yervoy and was 17% with Opdivo alone. In this updated analysis, no new safety signals were observed. Grade 3/4 treatment-related discontinuation rates were 10% in the Opdivo plus Yervoy group and 4% in the Opdivo group.

8:45 am Gapping up (SCANX) :

Gapping up
In reaction to strong earnings/guidance
:

  • COUP +6.3%, BOBE +4.8%, (also continues to evaluate all options to create shareholder value and is working with J.P. Morgan to review and evaluate potential opportunities for value creation; no formal timeline for the completion of the review )
  • CONN +4.5%, BMO +2.8%, HOME +2.5%, TOL +2%, AZO +1.1%, BNED +0.9%, HDS +0.6%

M&A news: IL +16.1% (to be acquired by Synchronoss Technologies (SNCR) for $13.00/share),P +3.2% (RBC's Mark Mahaney on CNBC says Sirius (SIRI) is front runner to acquire the company)

Select financial related names showing strength: DB +4.1%, RBS +3.6%, BCS +3.1%, CS +2.3%, SAN +1.9%, BBVA +1.4%, LYG +1%

Other news:

  • TXMD +27.7% (announces 'positive' top-line results from its pivotal phase 3 Replenish Trial of TX-001HR; trial met primary endpoints )
  • HTBX +23.4% (reports topline response and survival results in the ongoing Phase 1b study evaluating HS-110 in combination with Opdivo)
  • NVCN +11.3% (provides an update on the clinical experience with its Tiara transcatheter mitral valve)
  • DRYS +8.5% (continued strength)
  • SAGE +8.1% (announces its expedited development plan for SAGE-547 following receipt of formal meeting minutes from a meeting with the FDA)
  • NVLS +6.9% (CFO discloses the purchase of 24K shares)
  • IMMU +6.7% (IMMU-140 'demonstrated a significant antitumor effect)
  • CLNE +4.6% (announces two new fueling station construction projects and multiple projects for its Facility Modification Services)
  • VSTM +2.8% (reports Phase 2 DYNAMO clinical data; results in a 46% ORR)
  • ACHN +2.4% ( announces data presented at American Society of Hematology Meeting demonstrate potential advantages of factor D inhibition for the treatment of complement alternative pathway-mediated diseases )
  • BLCM +2.1% ( presents clinical results to date of BPX-501 pediatric program and provides regulatory update at investor event during ASH Annual Meeting)
  • AGIO +1.5% (reports new clinical data from Phase 1 Trial of Single Agent AG-120)
  • AZN +1% (reports Phase III trial of Tagrisso; demonstrates superiority over chemotherap)

Analyst comments:

  • ENPH +7% (initiated with a Buy at Craig Hallum)
  • HSBC +3.9% (upgraded to Equal Weight from Underweight at Morgan Stanley)
  • ZYNE +3.2% (resumed with a Buy at Jefferies)
  • UBS +2% (upgraded to Overweight from Equal Weight at Morgan Stanley
  • NFLX +0.7% (upgraded to Hold from Sell at Evercore ISI)
  • SKX +0.6% (initiated with a Outperform at Wells Fargo)

8:42 am VBI Vaccines completes sale of 3.475 mln common shares at $3.05/share in a private placement to Perceptive Advisors, for total gross proceeds of approx. $10.6 mln; co also announced $13 mln in secured debt (VBIV) :

  • Under the terms of the equity financing, VBI sold an aggregate of 3,475,000 of its common shares at a price of $3.05 per share in a private placement to Perceptive Advisors, for total gross proceeds of approximately $10.6 million.
  • Additionally, Perceptive Advisors increased its current credit agreement with VBI by funding an additional $13 million in secured debt. In conjunction with the additional debt funding, VBI issued a warrant to Perceptive Advisors for the purchase of an aggregate of 1,341,282 common shares at an exercise price of $3.36 per share.
  • Co intends to use the proceeds of the private placement for working capital and general corporate purposes, including the continued advancement of its growing pipeline of vaccine candidates.

8:41 am Barnes & Noble Education misses by $0.14, misses on revs; guides FY17 revs in-line; comps -2.9% due to lower enrollments and a softer retail environment (BNED) :

  • Reports Q2 (Oct) earnings of $0.64 per share, excluding non-recurring items, $0.14 worse than the Capital IQ Consensus of $0.78; revenues rose 2.0% year/year to $770.7 mln vs the $778.8 mln Capital IQ Consensus. Note, co reported GAAP EPS of $0.63 and non-GAAP income of $29.7 mln, but did not give a non-GAAP number on a per share basis. We simply divided by shares outstanding to get $0.64. It's a miss either way.
  • Co issues in-line guidance for FY17, sees FY17 revenue growth of +3-4% which we compute as $1.86-1.88 bln vs. $1.86 bln Capital IQ Consensus Estimate.
  • Oct same store comps decreased -2.9%.
  • "Though our new business wins enabled us to grow total sales, comparable store sales declined as a result of lower enrollments and a softer retail environment...Since we experienced lower textbook and general merchandise sales on our campuses, we are continuing the roll out of our price matching program and adjusting our promotional strategy in a targeted and disciplined manner to reflect current market conditions, and are continuing our cost management initiatives across the company. Consistent with this performance, we have revised our financial guidance to reflect the possibility that general merchandise sales remain softer than expected this fiscal year."
  • For FY17, co expects same store comps to decrease by 2.0% to 3.0% compared to the prior year.

8:33 am S&P futures vs fair value: +4.20. Nasdaq futures vs fair value: +13.30. (:WRAPX) :

Equity futures remain in the green with the S&P 500 futures up four points against fair value.

Unit labor costs increased 0.7% during the third quarter, which was higher than the 0.2% increase that had been anticipated by the Briefing.com consensus. Productivity was left unrevised at 3.1%. The Briefing.com consensus expected an increase of 3.3%.

The October trade balance showed a deficit of $42.6 billion while the Briefing.com consensus expected the deficit to come in at $41.8 billion. The previous month's deficit was revised to $36.2 billion from $36.4 billion.

8:32 am ePlus acquires the IT Services equipment and integration business of Consolidated Communications (CNSL) (PLUS) : Consolidated IT Services business provides data center, unified communications, networking, and security solutions to a diverse set of domestic and international customers including commercial, enterprise, and state, local, and education organizations in the upper Midwest. Consolidated IT Services is based in Minneapolis, MN and is a Cisco gold partner. As part of the transaction, ePlus and Consolidated Communications ESI, Inc. have entered into a co-marketing agreement to sell the other party's products and services to their customers. The acquisition of certain assets and the assumption of certain liabilities of Consolidated Communications IT Services closed on December 5, 2016. Terms were not disclosed. Consolidated Communications ESI had revenues of approximately $55 million for its fiscal year 2015.

8:32 am Cellectar Biosciences presents on its ongoing Phase I dose escalation clinical study of CLR 131 to assess safety & tolerability of the compound in patients with relapsed or refractory multiple myeloma at ASH 2016 (CLRB) :

CLR 131 is an investigational compound under development for a range of hematologic malignancies.

  • Results demonstrated all eight evaluable patients achieved a min of stable disease. The poster also reported a mean of approximately three months of progression-free survival in Cohort 1 and four months in Cohort 2. To date, one patient in Cohort 2 continues to experience PFS. Significantly, four of eight patients experienced a greater than 50 percent reduction in serum free light chains, which are a 'key efficacy indicator' for multiple myeloma. Per the International Myeloma Working Group criteria, in the absence of M protein, an FLC reduction of 50 percent or greater, is defined as a partial response. Overall, Cohort 2 patients experienced a more significant FLC reduction and a more sustained FLC response versus Cohort 1, with the difference in reduction being maintained across the entire study, and increasing at the subsequent evaluation time points. Cohort 2 patients achieved a 20 percent greater reduction in FLC on day 22 than was experienced by patients in Cohort 1, a 38 percent greater reduction at Day 43 and 43 percent greater FLC reduction at the final evaluation time point, Day 64.
  • Seven of eight evaluable patients achieved a reduction in either serum or urine M protein, which also are key efficacy indicators for multiple myeloma. Similar to the FLC marker, the Cohort 2 reduction of M protein was more sustained with the patients experiencing continued reduction in M protein beyond day 64. It is also important to note that based upon M protein reduction 38 percent of patients experienced a minimal response at these low, one-time doses.
  • The primary endpoint for this study is to determine the safety and tolerability of CLR 131 in a heavily pre-treated patient population. Evaluable study patients received an average of four prior lines of treatment. The adverse event profile in both cohorts was similar and showed no dose dependency. While the leading adverse events were leukopenia and thrombocytopenia with a median grade of 2 (mild to moderate) for both, there have been no dose-limiting toxicity events to date. Importantly, no patients experienced non-hematologic adverse events as seen with many other compounds used to treat this patient population. Specifically, there were no reports of peripheral neuropathy, fatigue, cardiovascular events, or venous thromboembolisms. The efficacy and safety profile of CLR 131 shown to date allows future development of the compound, either at the Cohort 2 dose of 18.75 mCi/m2 or at one of the future higher doses being tested. The study is currently completing Cohort 3 at a single 25 mCi/m2 dose.

8:31 am Recon Technology announces a patent for its proprietary Oilfield Wastewater Treatment Device by China's State Intellectual Property Office (RCON) :  

8:31 am Kadmon Holdings announces data from its ongoing Phase 2 clinical study of tesevatinib for the treatment of epidermal growth factor receptor NSCLC that has metastasized to the brain and/or the leptomeninges (KDMN) :

  • Eleven of the first 13 enrolled patients treated with tesevatinib 300 mg QD in this ongoing study did not have central nervous system (CNS) progression on tesevatinib. Eight of these patients showed an improvement in clinical symptoms, often by Day 14 of treatment. Intracranial radiological improvement was documented in four patients who had follow-up MRIs.
  • The study is being conducted in patients who have progressed with brain metastases and/or symptomatic leptomeningeal metastases while on prior therapy with other EGFR inhibitors, as well as in patients with no prior treatment and brain metastases at initial presentation.
  • Of the 13 enrolled patients, 12 had disease progression while on prior treatment with the EGFR inhibitor erlotinib and radiation therapy to the brain, five of whom had also received other EGFR inhibitors and chemotherapy. Currently approved EGFR inhibitors have poor brain penetration, limiting their ability to treat intracranial metastases. The rapid action of tesevatinib on clinical symptoms and shrinkage of tumor volumes demonstrates conclusively that tesevatinib enters the CNS and targets EGFR-driven tumors.
  • As expected, five of the 12 pretreated patients had peripheral disease progression, while in four of those five patients, tesevatinib controlled CNS lesions.
  • In addition to the results observed in pretreated patients, one enrolled patient with no prior treatment who presented with brain metastases showed a robust partial response in brain metastases in an MRI taken on Study Day 29 and showed a partial response in both brain metastases and peripheral disease at Study Day 57. This patient continues on tesevatinib as of Study Day 92. These findings support the notion that tesevatinib monotherapy has the potential to be a first-line treatment in this patient population.

8:31 am Theravance Biopharma announces that the FDA granted Fast Track designation to Velusetrag for the treatment of symptoms associated with idiopathic & diabetic gastroparesis (TBPH) :  

8:31 am Synopsys initiates a $100 mln accelerated share repurchase agreement (SNPS) : Synopsys will receive an aggregate initial share delivery of approximately 1.39 million shares, with the remainder to be settled on or before Feb 16, 2017, upon completion of the repurchase. The specific number of shares that Synopsys ultimately repurchases under the ASR will be based on Synopsys' volume-weighted average share price during the repurchase period, less a discount.

8:29 am On The Wires (:WIRES) :

  • XBiotech Inc. (XBIT) announces thatenrollment has been completed in its randomized, placebo-controlled Phase I/IIstudy evaluating dosing, safety and efficacy of the Company's novel antibodytherapy, 514G3. This proprietary antibody therapy has received Fast TrackDesignation by the FDA for the treatment of all forms of Staphylococcusaureus infections, including Methicillin-resistant S. aureus (:MRSA). The Company reports that top-line findings from the 514G3 study should be reported in firstquarter 2017.
  • CoreLogic (CLGX) released its CoreLogic Home Price Index (HPI) and HPI Forecast for October 2016 which shows home prices are up both year over year and month over month.  The CoreLogic HPI Forecast indicates that home prices will increase by 4.6 percent on a year-over-year basis from October 2016 to October 2017, and on a month-over-month basis home prices are expected to increase by 0.2 percent from October 2016 to November 2016.
  • CymaBay Therapeutics (CBAY) announces that the World Health Organization has recommended seladelpar as the designated international nonproprietary name for MBX-8025.
  • iCAD (ICAD) announces that researchers will present updated data on the use of intraoperative radiation therapy (:IORT) with the Xoft Axxent Electronic Brachytherapy (eBx) System during the San Antonio Breast Cancer Symposium (:SABCS) in San Antonio, Texas. The data include results from a subset of patients who received IORT with the Xoft System as a boost prior to administration of whole breast radiation therapy (:WBRT) in patients with early-stage breast cancer. The Xoft System and its suite of products will be showcased at SABCS in the Xoft booth (#257) from December 6-10, 2016.
  • Tissue Regenix Wound Care announces the company has been awarded a group purchasing contract with Premier (PINC). The agreement provides Premier members with access to DermaPure human dermal allograft featuring dCELL technology for the treatment of complex, acute and chronic wounds.
  • Parsley Energy, a subsidiary of Parsley Energy, Inc. (PE) announces that it has commenced a cash tender offer to purchase any and all of its 7.500% senior unsecured notes due 2022. As of December 5, 2016, there was $550 million aggregate principal amount of the 2022 Notes outstanding. The tender offer is being made pursuant to an offer to purchase, dated today, and a related letter of transmittal and notice of guaranteed delivery. The tender offer will expire at 5:00 p.m., New York City time, on December 12, 2016, unless extended (the "Expiration Time"). Tendered 2022 Notes may be withdrawn at any time before the Expiration Time.

8:23 am Merck announces updated Keytruda data in small cell lung cancer and mesothelioma presented at 17th World Conference on Lung Cancer (MRK) :

Keytruda is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

  • Results from KEYNOTE-028 SCLC Cohort
    • Updated findings from 24 heavily pre-treated patients with advanced SCLC demonstrated a confirmed ORR of 33.3 percent, including one complete response and seven partial responses. One patient had stable disease and 13 patients had progressive disease. Responses were durable, with a median duration of response of 19.4 months.
    • Additionally, the median PFS was 1.9 months, with a six-month PFS rate of 28.6 percent and 12-month PFS rate of 23.8 percent. The median OS was 9.7 months, with a six-month OS rate of 66.0 percent and a 12-month OS rate of 37.7 percent. The safety profile of Keytruda was consistent with that observed in previously reported studies. Grade 3-5 treatment-related adverse events were asthenia, blood bilirubin increased, colitis and intestinal ischemia. Some patients experienced adverse events of special interest, including autoimmune thyroiditis, infusion site reaction, cytokine release syndrome and colitis.
  • Results from KEYNOTE-028 Malignant Pleural Mesothelioma Cohort
    • Results showed a confirmed ORR of 20.0 percent. All responses were partial responses and 13 patients had stable disease. The median duration of response was 12.0 months. In total, 60.9 percent of evaluable patients experienced a decrease in tumor size. Additionally, the median PFS was 5.4 months, with a six-month PFS rate of 45.8 percent and a 12-month PFS rate of 20.8 percent. Median OS was 18.0 months, with a six-month OS rate of 83.5 percent and a 12-month OS rate of 62.6 percent.
    • The safety profile of Keytruda was consistent with that observed in previously reported studies. Grade 3 treatment-related adverse events were ALT increase, appetite decrease, dyspnea, iridocyclitis, neutrophil count decreased, pyrexia and thrombocytopenia. Some patients experienced adverse events of special interest, including erythema/erythema multiforme, hypothyroidism, infusion-related reaction, iridocyclitis and rhabdomyolysis. There were no Grade 4 or 5 treatment-related adverse events and no treatment-related deaths.

8:20 am Heat Biologics reports topline response and survival results in the ongoing Phase 1b study evaluating HS-110 in combination with Opdivo for the treatment of non-small cell lung cancer (HTBX) :

In an oral presentation, principal investigator, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, reported that one-year results from the first eight trial patients showed that the HS-110/nivolumab combination was well-tolerated, with a safety profile consistent with single agent nivolumab. There were no additional toxicities seen in HS-110/nivolumab combination compared to existing data on single agent nivolumab alone. HS-110 generated a robust antigen-specific immune response in several patients, consistent with the mechanism of action seen in other HS-110 trials. Additionally, the patients who responded best to the combination therapy (immune responders) had longer overall survival and better objective response rate (:ORR) than the non-immune responders, even though they had the same baseline immune function.

  • Immune responders in the study saw a 50% ORR, while non-immune responders saw a 0% ORR. This is important, as checkpoint inhibitors have been shown, independently, to be much more effective in tumors with pre-existing, high tumor-infiltrating lymphocytes (TIL). As such, there now exists an acute need to address the large proportion of non-responders with low-TIL tumors.
  • Moreover, the immune responders had a better median overall survival (:OS) than non-immune responders. The one-year OS is currently 50% for the responders, and 25% for the non-responders. Finally, immune responders also saw a better median OS at 12.7 months, than non-immune responders, who saw a median OS of 7.1 months. Researchers concluded that immune response may correlate with clinical efficacy and that HS-110 may have synergistic activity with immune checkpoint inhibitors.
  • "We were impressed by the ability of HS-110 to activate a CD8+ T cell immune response. The HS-110/nivolumab combination is worth continued exploration in the treatment of lung cancer, as the HS-110 mechanism of action is potentially synergistic with anti-PD-1 checkpoint inhibitors."

Heat plans to hold an investor call on December 8th at 8:30 a.m. ET to discuss its overall clinical strategy moving forward.

8:11 am Parsley Energy announces a $600 mln private placement of senior unsecured notes due 2025 (PE) : Parsley intends to use the net proceeds from the notes offering, along with cash on hand, to repurchase for cash any and all of the Issuers' outstanding 7.500% senior unsecured notes due 2022 pursuant to a tender offer, pay fees and expenses thereof and, at its option, redeem any of the 2022 notes that remain outstanding thereafter. The notes offering is not conditioned on the consummation of the tender offer. The tender offer is conditioned on, among other things, the notes offering.

8:07 am KNOT Offshore Partners announces private placement of $50 million of new Series A Convertible Preferred Units at $24.00/unit (KNOP) : The Partnership expects to use the net proceeds for general partnership purposes, which may include acquisitions, capital expenditures or the repayment of indebtedness.

8:05 am Vectrus appoints Charles Prow President & CEO, effective today (VEC) : Prow was also appointed to the board of directors and succeeds Kenneth W. Hunzeker, who retired effective Dec 5, 2016. Prow has 25 years of experience with positions at IBM Corporation, PricewaterhouseCoopers, and Coopers & Lybrand.

8:05 am American Express acquires InAuth, provider of mobile device authentication and intelligence solutions; financial details not disclosed (AXP) :  

8:03 am Inovio Pharma announces that the International Vaccine Institute will provide new funding and support to further advance GLS-5300, Inovio's vaccine to prevent MERSS virus infection (INO) :

Dr. J. Joseph Kim, Inovio's President & CEO and a member of the Board of Trustees of IVI, said, "This collaborative funding is part of a 41 billion Won (USD $34 million) grant publicly pledged in 2015 from the Samsung Foundation to IVI to support the development of a MERS vaccine for emergency use in Korea and internationally. The goal of this funding is to expand clinical testing of GLS-5300 toward emergency use authorization by the Korean government as well as authorities of other countries.... Inovio's GLS-5300 remains the only vaccine for MERS in clinical testing. With this support from IVI, Inovio, GeneOne, and our other collaborators can expand GLS-5300 vaccine development in Korea and the US. Our phase I MERS trial in the U.S. is fully enrolled with 75 subjects dosed. We intend to report interim data in early 2017 and publish the full data set in peer reviewed journals. We already published positive non-human primate protection results. After obtaining human safety and immunogenicity data, we may be in position to secure additional external funding as well as approach regulators next year to discuss the path to approval via the "Animal Rule," Dr. Kim said.

8:03 am Johnson & Johnson subsidiary Janssen announces new analysis presented with Bayer (BAYRY) shows people with cancer who received Xarelto for blood clots had fewer ER visits and lower healthcare costs than those given standard treatment (JNJ) :

  • The analysis presented this week by Janssen and its development partner, Bayer (BAYRY), at the 2016 American Society of Hematology (ASH) Annual Meeting examines the use of Xarelto in cancer-associated thrombosis, an area of critical unmet need.
  • In the first six months of the study, similar rates of people were sent to the ER to start anticoagulation treatment between the Xarelto and LMWH groups (71% vs. 63%, respectively). After those six months, there was a significant decrease in people starting treatment with Xarelto in the ER from 71% at baseline to 42% at one year and 34% at 18 months, which researchers attributed to physicians becoming more familiar with Xarelto.
  • After one year, 18% of people who were prescribed Xarelto were managed by a simple telephone call, typically after a recent outpatient visit. Researchers also observed significant cost savings for people taking Xarelto, which was mainly due to the reduction in ER visits. The start of anticoagulation treatment was classified in one of four ways: an ER visit, a second return outpatient visit on the same day, a single outpatient visit or a telephone communication. Patients whose VTE developed as an inpatient were excluded.

8:02 am America First Tax Exempt Investors to issue 700k Series A Preferred units representing L.P. interests in the partnership resulting in $7 mln in aggregate proceeds to the Partnership (ATAX) : ATAX entered into a Subscription Agreement to issue 700,000 Series A Preferred Units representing limited partnership interests in the Partnership resulting in $7 million in aggregate proceeds to the Partnership. The Preferred Units (which are non-cumulative, non-convertible and non-voting) are a class of limited partnership interests in the Partnership and are being issued pursuant to a private placement of up to a maximum of $100 million. The Private Placement is directed solely to insured depository institutions chartered under the laws of any state or the District of Columbia, or of the United States. The Partnership will use the proceeds received in the Private Placement, including the closing of the second subscription agreement described above, to acquire mortgage revenue bonds that are issued by state and local housing authorities to provide construction and/or permanent financing for affordable multifamily and student housing and commercial properties.

8:02 am S&P futures vs fair value: +2.50. Nasdaq futures vs fair value: +10.00. (:WRAPX) :

U.S. equity futures trade in the green this morning, with the S&P 500 futures up three points above fair value.

Oil prices dropped from their 16-month high overnight. This drop in price has shifted the focus to Saturday's non-OPEC producers meeting in Vienna to see if non-OPEC countries will mimic the OPEC production cuts. WTI Crude is currently at $51.15/bbl.

Treasuries have gained a little momentum, putting the 10-yr yield down one basis point to 2.39%.

In U.S. corporate news of note:

  • Apple (AAPL 109.50, +1.24): +1.1% after seeing record watch sales over the first holiday week, according to Reuters.
  • Autozone (AZO 784.95, +8.53): +1.1% after beating earnings estimates.
  • HD Supply Holdings (HDS 40.00, +0.25): +0.6% after reporting earnings in-line with the company's November 9th announcement.

Reviewing overnight developments:

  • Asian equity indices ended on a higher note. Japan's Nikkei +0.5%, Hong Kong's Hang Seng +0.8%, China's Shanghai Composite -0.2%
    • In economic data:
      • Japan's Average Cash Earnings +0.1% year-over-year (consensus 0.2%; last 0.0%) and October Overtime Pay -1.4% year-over-year (last -1.3%)
      • Australia's Q3 Current Account deficit narrowed to AUD11.40 billion from AUD15.90 billion (expected deficit of AUD13.70 billion)
    • In news of note:
      • Press reports from Japan indicated the country may issue mid-year deficit bonds, marking the first such issue since 2009.
      • The Reserve Bank of Australia kept its key interest rate at 1.5%, as expected.
      • The People's Bank of China strengthened the yuan fix to mid-November levels.
  • Major European indices trade in the green. Germany's DAX +0.2%, UK's FTSE +0.2%, France's CAC +0.3%, Italy's MIB +0.6%
    • In economic data:
      • Eurozone Q3 GDP +0.3% quarter-over-quarter, as expected (last 0.3%); +1.7% year-over-year (consensus 1.6%; last 1.6%). Retail PMI held at 48.6.
      • Germany's October Factory Orders +4.9% month-over-month (expected 0.6%; last -0.3%)
      • Swiss November CPI -0.2% month-over-month (expected -0.1%; last 0.1%); -0.3% year-over-year (consensus -0.2%; last -0.2%)
    • Among news of note:
      • According to the Italian Interior Ministry, the country is on track for an election in February. Prime Minister Matteo Renzi agreed to delay his resignation until a budget for next year is passed.
      • After yesterday's Eurogroup meeting in Greece, it is still not known whether the International Monetary Fund will take part in the Greek bailout after expressing concerns about insufficient debt relief included in the deal.

8:02 am Altria announces Philip Morris International submitted a Modified Risk Tobacco Product application for an electronically heated tobacco product with the FDA Center for Tobacco Products (MO) : FDA will now determine whether to accept the application for substantive review. Upon regulatory authorization by the FDA, Altria's companies have an exclusive license to sell this heated tobacco product in the United States.

8:01 am Asure Software prices underwritten public offering of 1,695,000 newly issued shares of common stock at $8.00/share (ASUR) : Asure intends to use the net proceeds received from the sale of the common stock for general corporate purposes, including the payment of a portion of its outstanding subordinated indebtedness.

8:01 am Equinix to acquire a portfolio of 24 data center sites and their operations from Verizon (VZ) for $3.6 bln (EQIX) :

The 24 sites consist of 29 data center buildings across 15 metro areas. The addition of these strategic facilities and customers will further strengthen Equinix's global platform by: increasing interconnection in the U.S. and Latin America; opening three new markets in Bogot, Culpeper and Houston; and accelerating Equinix's penetration of the enterprise and strategic market sectors, including government and energy.

  • The acquired portfolio includes approximately 900 customers, with a significant number of enterprise customers new to Equinix's platform, and it adds approximately 2.4 million gross square feet. It will bring Equinix's total global footprint to 175 data centers in 43 markets and approximately 17 million gross square feet across the Americas, Europe and Asia-Pacific markets. The transaction is expected to close by mid-2017, subject to the satisfaction of customary closing conditions.
  • "This unique opportunity complements and extends Equinix's strategy to expand our global platform. It enables us to enhance cloud and network density to continue to attract enterprises, while expanding our presence in the Americas. The new assets will bring hundreds of new customers to Platform Equinix while establishing a presence in new markets and expanding our footprint in existing key metros. The deal will also provide significant value for shareholders as the proposed transaction is expected to be immediately accretive to our adjusted funds from operations per share upon close."

8:01 am AzurRx BioPharma agrees in principle with TransChem to license TransChem's proprietary transition state chemistry technology for MTAN inhibition (AZRX) :

Co reaches an agreement in principle with TransChem to license TransChem's proprietary transition state chemistry technology for MTAN inhibition. MTAN plays a key role in bacterial quorum sensing.

  • "We believe this technology will enable us to tackle one of the major frontiers in medicine, the impact of bacterial biofilms on humans. This proposed license from TransChem will be a step forward in positioning AzurRx BioPharma to become a significant player in the development of non-systemic therapies for gastrointestinal and infectious diseases."

8:00 am Microbot Medical appoints Hezi Himelfarb as Chief Operating Officer (:MBOT) :

Mr. Himelfarb joins Microbot after serving since 2008 as the Chief Executive Officer of IceCure-Medical Ltd., a Tel Aviv Stock Exchange listed company focused on advanced cryotherapy systems intended for the growing physician-office market.

7:59 am On The Wires (:WIRES) :

  • Endo International plc (ENDP) announces that one of its operating companies, Par Pharmaceutical, has begun shipping mycophenolate mofetil hydrochloride (HCl) for injection following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Par's mycophenolate mofetil hydrochloride (HCl) for injection is the generic version of Roche's CellCept and is the first and currently the only generic injectable available. According to IMS Health data, U.S. sales of injectable CellCept were approximately $42 million for the 12 months ended October 31, 2016.
  • Ormat Technologies (ORA) announces that its subsidiary, Ormat Nevada Inc., concluded and signed a $36 million engineering, procurement and construction (EPC) contract with a subsidiary of Cyrq Energy, Inc. (Cyrq). Under the EPC contract, Ormat will provide one air-cooled ORMAT ENERGY CONVERTER (OEC) at Cyrq's Soda Lake geothermal power project in northern Nevada. The project is expected to come on line in the first half of 2018.
  • Medallion Midstream, LLC and its affiliate, Medallion Midstream Services, LLC, entered into a letter of intent to construct a new Delaware Basin crude oil pipeline system to provide crude oil gathering and transportation services for Parsley Energy (PE) . The new pipeline will be anchored by Parsley's long-term dedication to Medallion of approximately 35,000 acres held under lease and/or mineral interest in Pecos and Reeves Counties, Texas.
  • Jacobs Engineering Group (JEC) receives a contract from the New Jersey Department of Transportation to provide construction inspection services for the Smart Moves 2015 -- North program. Under the terms of the contract Jacobs is overseeing inspection work in the City of Newark; the townships of Clinton, Parsippany -- Troy Hills, and West Milford; and the counties of Essex, Hunterdon, Morris, and Passaic, New Jersey.

7:50 am HomeStreet announces $60 mln common stock at-the-market equity offering (HMST) : Co intends to use the net proceeds, if any, for general corporate purposes and possible future acquisitions or growth opportunities. The Company may also use a portion of the net proceeds to provide new capital to the HomeStreet Bank to support its future growth. Pending allocation to specific uses, the Company intends to invest the proceeds in short-term interest-bearing investment grade securities. The Company does not have any immediate plans, arrangements or understandings relating to any material acquisition.

7:37 am Francesca's beats by $0.05, beats on revs; guides Q4 in-line (FRAN) :

  • Reports Q3 (Oct) earnings of $0.23 per share, excluding non-recurring items, $0.05 better than the Capital IQ Consensus of $0.18; revenues rose 15.2% year/year to $119.5 mln vs the $116.28 mln Capital IQ Consensus. This was due to a 7% increase in comparable sales (vs. mid-single comp guidance) primarily driven by an increase in the number of transactions both at boutiques and on-line as well as the addition of 50 net new boutiques since the prior year quarter. The Company opened 18 boutiques and closed one boutique during the quarter, bringing the total boutique count to 669 at the end of the quarter. Ecommerce comparable sales increased 47% to $5.7 million driven by increased website traffic and conversion rate.
    • Gross profit, as a percent of net sales, increased to 48.2% from 46.6% in the prior year quarter. This increase was attributable to 40 basis points of higher merchandise margin and 120 basis points of occupancy costs leverage. The increase in merchandise margin was mostly due to favorable mix change and lower markdowns compared to the prior year quarter.
  • Co issues in-line guidance for Q4, sees EPS of $0.36-0.40, excluding non-recurring items, vs. $0.38 Capital IQ Consensus Estimate; sees Q4 revs of $143-148 mln vs. $144.26 mln Capital IQ Consensus; low-single digit decline to low single digit increase in comps.

7:36 am Ariad Pharm announces results of studies on Iclusig in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia at ASH 2016 (ARIA) :

Iclusig is indicated as a treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia for whom no other tyrosine kinase inhibitor therapy is indicated. It is also indicated as a treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

  • Ponatinib in Chronic-Phase Chronic Myeloid Leukemia Patients: Final Report from a Phase 1 Trial
    • Anti-leukemic activity was observed with ponatinib treatment:
      • Results showed that 72 percent of CP-CML patients had a major cytogenetic response (MCyR), 65 percent had a complete cytogenetic response (CCyR) and 56 percent had a major molecular response (:MMR), a key secondary endpoint deeper than cytogenetic response.

      • Of note, 44 percent of CP-CML patients achieved MR4, 33 percent achieved MR4.5, and 26 percent achieved MR5; MR4, MR4.5 and MR5 are deeper levels of molecular response than MMR. The median time to MCyR, CCyR and MMR was 2.8, 5.5 and 7.4 months, respectively.
        By Kaplan-Meier analysis, among those who achieved response, median duration of MMR was 27.1 months. Median durations of MCyR, CCyR were not reached.
  • Long-Term Follow-up of the Efficacy and Safety of Ponatinib in Philadelphia Chromosome-Positive Leukemia Patients with the T315I Mutation
    • Responses continue to be observed in CP-CML patients with T315I patients treated with ponatinib at four years. In the combined analysis of these patients from both trials:
      • 75 percent (57/76) of T315I+ CP-CML patients achieved MCyR, 72 percent achieved CCyR, and 61 percent achieved MMR.
      • By Kaplan-Meier estimate, 83 percent of patients with response were estimated to maintain MCyR at four years, and 81 percent were estimated to maintain CCyR at four years.
      • The median duration of response has not yet been reached. The probability for overall survival in CP-CML patients with T315I in PACE at 4.5 years was 72 percent.
    • Analysis of the Sub-Clonal Origins of Compound Mutations in Patients with Refractory Ph+ Malignancies Treated with Ponatinib
      • In the PACE study, ponatinib induced high rates of major hematological response (MaHR) and MCyR in Ph+ ALL patients (41% and 47%), even though 91 percent of these patients had received at least two prior TKIs.
        • For these patients, median progression-free survival was three months for Ph+ ALL patients.
        • In TKI refractory patients treated with ponatinib, Ph+ ALL patients gained BCR-ABL compound mutants at end of treatment more often than CP-CML patients.
        • Coupled with estimates of leukemia initiating cell fractions, these data estimate the clinical propensity of Ph+ ALL to acquire on-target mutations. These findings provide a molecular hypothesis for the observation that Ph+ ALL patients treated with ponatinib in the front-line had estimated 80 percent overall survival at three years.

7:34 am Almost Family announces new five-year $350 million revolving credit facility and also announces that it cleared the necessary regulatory approvals for the previously announced agreement to acquire a controlling interest in Community Health Systems (CYH) (AFAM) :

  • The $350 million revolving credit facility replaces the Company's previous $175 million credit facility. The Facility includes an accordion feature which permits expansion up to $500 million.
    • Borrowings, other than letters of credit, under the Facility generally will bear interest at a rate varying from LIBOR rate plus 1.50% to LIBOR rate plus 2.75%, depending on leverage (0.25% lower than the previous facility). The Facility is secured by substantially all of the Company's assets and the stock of its subsidiaries.
  • The Company also announced that it cleared the necessary regulatory approvals for the previously announced agreement to acquire a controlling interest in the entity holding the home health and hospice assets of Community Health Systems.
    • With the completion of this transaction, Almost Family will operate 340 branches across 26 states and its annual net revenue run rate is expected to exceed the $800 million mark.
    • The Company expects to fund the acquisition on December 30, 2016 the last day of its fiscal year.

7:32 am Perma-Fix Enviro enters into an initial term sheet with Acsion Industries to support the development of several products, including a Technetium-99 generator (PESI) : Stephen Belcher, Chief Executive Officer of Perma-Fix Medical S.A., stated, "With the support of Acsion, we are more confident than ever we can achieve our commercial goals with far lower investment and less impact to the environment than alternative approaches, with a vertically integrated supply chain from the initial purchase of molybdenum-98 through to finished product."

7:32 am TG Therapeutics announces data was presented yesterday from 3 combination studies involving TGR-1202 & TG-1101 at the ASH Annual Meeting (TGTX) :

  • Phase I Trial of TGR-1202, a Next Generation Once-Daily PI3Kd Inhibitor, in Combination with Brentuximab Vedotin, in Patients with Relapsed/Refractory Hodgkins Lymphoma.
    • 60% (3 of 5) ORR, including a 40% CR rate observed across brentuximab vedotin refractory patients.
    • 64% (7 of 11) ORR, including a 45% CR rate observed across all patients treated.
  • Preliminary Results from a Phase I Dose Escalation Trial of Ruxolitinib and the PI3Kd Inhibitor TGR-1202 in Myelofibrosis
    • The patient population enrolled was advanced, with the majority having 2 or more prior mutations at baseline
    • Per protocol, all enrolled patients were on a stable dose of ruxolitinib monotherapy with best response to ruxolitinib monotherapy achieved prior to enrollment
    • Following the addition of TGR-1202, 11/12 patients experienced improvement in hemoglobin, many with a concomitant reduction in platelet counts indicating clinical benefit beyond ruxolitinib monotherapy
    • 83% of study participants experienced clinical benefit (hematologic improvement, reduced spleen size and/or improvement in symptoms) including one patient who achieved a CR and continues on study, now out 72 weeks.

7:31 am Volaris Aviation reports November 2016 prelim traffic results; RPMs +19.9% Y/Y, ASMs +15.9% Y/Y, load factor of 84.6%, +2.8% Y/Y (VLRS) :

  • During November 2016 Volaris increased total capacity, as measured in ASMs, +15.9% Y/Y, in response to strong demand in its domestic and international markets.
  • Total demand, as measured in RPMs, in November 2016 +19.9% Y/Y, reaching 1.2 bln.
  • Co transported a total of 1.3 million passengers during the month, +21.1% Y/Y.
  • In November 2016, Volaris increased domestic and international ASMs by 14.1% and 20.4%, respectively.
  • Network load factor for November reached 84.6%, +2.8% Y/Y.

7:31 am Real Goods Solar announces public offering of common stock & series I warrants to purchase shares of common stock; size not disclosed (RGSE) :  

7:31 am Digital Ally announces plans to enter the non-lethal weapon market (DGLY) : To protect its innovation in this market, the Company filed a U.S. Patent Application for its first electroshock weapon in May 2015. The application was recently published by the United States Patent and Trademark Office (:USPTO), which automatically publishes applications 18 months from filing. The application awaits examination by the USPTO. Digital Ally has developed the intellectual property for a wirelessly controlled electronic weapon. As designed, the electroshock weapon would fire a wireless direct contact projectile from a launcher to administer the shock to the subject. The launcher is controlled by radio frequency. In addition to reducing the projectile velocity at launch and allowing the officer to control the shock wirelessly through radio frequency, the Company's wirelessly controlled electronic weapon is designed to be more compact, easy to carry, and provide improved accuracy.

7:30 am CECO Environ. appoints Matthew Eckl as CFO effective Jan 9, 2017 (CECE) :

  • Edward Prajzner, the Company's current Chief Financial Officer, will serve in the new role as Executive Vice President of Corporate Development.
  • Eckl currently serves as the Vice President, Finance -- Energy Group at Gardner Denver.

7:29 am On The Wires (:WIRES) :

  • Egalet Corporation (EGLT) announces the United States Patent and Trademark Office has issued patent number 9,498,446 covering Egalet's proprietary Guardian Technology abuse-deterrent products which contain a matrix and an exterior shell including Phase 3 product candidate, Egalet-002. The patent offers protection through February 2030 for Egalet-002 and other products developed with a shell using Guardian Technology.
  • TG Therapeutics (TGTX) announces that the target enrollment of 120 patients in the GENUINE Phase 3 study has been met and enrollment will be closed shortly. The GENUINE Phase 3 study is a randomized study of TG-1101, the Company's novel, glycoengineered anti-CD20 monoclonal antibody in combination with ibrutinib, the oral Bruton's tyrosine kinase, versus ibrutinib alone in approximately 120 patients with high-risk relapsed or refractory Chronic Lymphocytic Leukemia. In October, the study was modified to convert the primary endpoint solely to Overall Response Rate. If the study results are positive, and subject to a positive outcome of pre-BLA meeting with the FDA, the Company plans to utilize the results to file for accelerated approval. The Company expects to release top-line data from the GENUINE Phase 3 study in the first half of 2017.
  • Onconova Therapeutics (ONTX) and Cellworks presented at ASH 2016. The presentation by Dr. Guillermo Garcia-Manero from the MD Anderson Cancer Center, lead investigator from the ONTME trial, used Cellworks' proprietary bio-simulation platform to retrospectively correlate clinical benefit to IV rigosertib treatment in the Phase 3 ONTIME study in HR-MDS patients with molecular and cytogenetic data. This computer simulation led to the characterization of certain biological pathways that predict response to IV rigosertib in HR-MDS patients. Notably, patients with these predictive biological pathways also shared common cytogenetic abnormalities -- trisomy of chromosomes 8 and 21 -- that correlated with positive clinical outcome in ONTIME.
  • Omeros Corporation (OMER) will provide continued supply of OMS721 for a pediatric patient with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who is currently receiving the drug under the company's compassionate use program. The patient's treating physician requested extended access to OMS721 for his 15 year-old patient given her positive results with OMS721 treatment, including discontinuation of dialysis. HSCT-TMA most commonly affects the kidneys but can also damage the lungs, gastrointestinal tract and central nervous system, and severe cases often require dialysis and carry a mortality rate in excess of 90 percent. In addition to its Phase 2 clinical program in TMA, OMS721 is currently in a Phase 3 program for patients suffering from atypical hemolytic uremic syndrome and in a Phase 2 program for renal diseases, including immunoglobulin A (IgA) nephropathy and membranous nephropathy.
  • Barracuda Networks Inc. (CUDA) and High-Tech Bridge SA announce a technology alliance and integration of High-Tech Bridge's ImmuniWeb Web Security Testing Platform and Barracuda's Web Application Firewall from version 9.0 and above. The integration will allow customers to deploy virtual patching of web application vulnerabilities in just a few clicks.

7:17 am Magellan Midstream and LBC Tank Terminals are expanding the infrastructure of Seabrook Logistics, owned 50/50 by subsidiaries of the cos, by increasing its crude oil and condensate storage and pipeline assets in the Houston Gulf Coast area (MMP) :

Seabrook Logistics is constructing 1.7 million barrels (270,000 cubic meters) of additional crude oil and condensate storage adjacent to LBC's existing terminal in Seabrook, Texas.

  • In addition, Seabrook Logistics is connecting its facility to Magellan's Houston crude oil distribution system by constructing a 24-inch (61-centimeter) diameter bi-directional pipeline between the Seabrook Logistics' facility and Genoa Junction and investing in a new Aframax dock with up to a 45-foot draft.
  • The expansion is currently estimated to cost $250 mln and be operational during mid-2018, subject to receipt of necessary permits and regulatory approvals.
  • Further, in anticipation of incremental volume on Magellan's Houston crude oil distribution system, Magellan is separately investing an additional $70 mln to build a new 24-inch diameter pipeline from its East Houston terminal to Holland Avenue.
    • Magellan's new crude oil pipeline segment is also expected to be operational during mid-2018.

7:16 am European Markets Update: DAX +0.2%, FTSE +0.2%, CAC +0.3% (:SUMRX) :

Major European indices trade in the green with Italy's MIB (+0.6%) showing relative strength. According to the Italian Interior Ministry, the country is on track for an election in February. Prime Minister Matteo Renzi agreed to delay his resignation until a budget for next year is passed. With the main focus on Italy, participants may have overlooked yesterday's Eurogroup meeting on Greece. It is not yet known whether the International Monetary Fund will take part in the Greek bailout after expressing concerns about insufficient debt relief included in the deal.

  • In economic data:
    • Eurozone Q3 GDP +0.3% quarter-over-quarter, as expected (last 0.3%); +1.7% year-over-year (consensus 1.6%; last 1.6%). Retail PMI held at 48.6.
    • Germany's October Factory Orders +4.9% month-over-month (expected 0.6%; last -0.3%)
    • Swiss November CPI -0.2% month-over-month (expected -0.1%; last 0.1%); -0.3% year-over-year (consensus -0.2%; last -0.2%)

---Equity Markets---

  • Germany's DAX is higher by 0.2% with utilities and financials among the leaders. E.On, RWE, Deutsche Bank, and Commerzbank are up between 1.4% and 5.3%. On the downside, Linde, Henkel, and Siemens are all down near 0.8%.
  • UK's FTSE trades up 0.2% with financials contributing to the advance. HSBC, RBS, Land Securities, British Land Company, Intu Properties, and Barclays hold gains between 1.4% and 3.3%. Miners are on the defensive with Anglo American, BHP Billiton, Rio Tinto, and Glencore down between 1.5% and 3.7%.
  • France's CAC has climbed 0.3%. Financials Societe Generale, BNP Paribas, and Credit Agricole are among the leaders with gains between 1.0% and 3.2%. On the downside, energy names Total and Technip are both down near 0.7% while Airbus and Valeo show respective losses of 1.1% and 1.6%.
  • Italy's MIB is higher by 0.6%. Financials like Mediobanca, UBI Banca, Intesa Sanpaolo, Unicredit, and Banca Pop Emilia Romagna are up between 0.9% and 3.7%.

7:08 am Michaels Stores misses by $0.03, misses on revs; guides Q4 EPS below consensus; Q3 comps -2% vs guidance of +0.5-1.5%; authorizes $300 mln stock repurchase program (MIK) :

  • Reports Q3 (Oct) earnings of $0.40 per share, excluding non-recurring items, $0.03 worse than the Capital IQ Consensus of $0.43; revenues rose 5.0% year/year to $1.23 bln vs the $1.26 bln Capital IQ Consensus. Comparable store sales decreased 2.0% (guidance +0.5-1.5%) driven by a decrease in customer transactions, which was partially offset by an increase in average ticket.
  • Co issues downside guidance for Q4, sees EPS of $0.94-0.98, excluding non-recurring items, vs. $0.99 Capital IQ Consensus Estimate; Co sees Q4 comps flat to down 1.5%.
  • Gross profit increased 0.2% to $466.6 million, from $465.6 million in the third quarter of fiscal 2015.
  • As a percentage of net sales, gross profit was 38.0% compared to 39.8% in the third quarter of fiscal 2015.
  • In December 2016, the Board of Directors authorized the Company to purchase, from time to time, as market conditions warrant, $300 million of the Company's common stock, which is in addition to its prior repurchase authorization. 

7:06 am Auris Medical confirms that the TACTT3 Phase 3 trial with Keyzilen will resume enrollment in early 2017 per previous guidance following receipt of approvals from European regulatory agencies and ethics committees on the protocol amendment (EARS) :

As part of its continued dialogue with the FDA, Auris Medical recently had two meetings related to the Keyzilen program.

  • Through a Type C Meeting, the FDA confirmed that, as per standard practice, two positive confirmatory trials would be required to submit a NDA; the Agency did not provide feedback on the TACTT3 protocol amendment because the trial is being conducted in Europe and is not under the Investigational NDA.
  • In a separate meeting with the FDA, alignment was achieved on key items of the Keyzilen Chemistry, Manufacturing, and Controls section for a future NDA.

7:06 am Pluristem Therapeutics announces a milestone in its development program for PLX-R18; data expected in first half of 2017 (PSTI) :

PLX-R18 is being evaluated as a medical countermeasure in the treatment of the hematologic components of Acute Radiation Syndrome by the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health.

  • The NIAID has now completed the dosing of the first cohort and is preparing to initiate dosing of the second and final cohort. Data from the completed study are expected in the first half of 2017. Based on these data the optimal treatment dose will be chosen for a pivotal large animal study designed to meet the requirements for a Biologics License Application submission under the FDA's Animal Rule regulatory pathway.

7:05 am SAGE Therapeutics announces its expedited development plan for SAGE-547 following receipt of formal meeting minutes from a meeting with the FDA; 'path forward for SAGE-547 to potentially support a NDA in 2018' (SAGE) :

The current SAGE-547 program in PPD, along with prior Phase 2 data, were confirmed as supporting, if successful, a potential NDA. Sage's PPD clinical program, now in Phase 3, will require only minor modifications, including an increase in sample size.

  • Agreement with the FDA was achieved on the clinical endpoints for these pivotal trials.
  • Co anticipates announcing top-line data from the PPD registration trials in 2H17.
  • "We are encouraged by the FDA's feedback and appreciate their guidance regarding our SAGE-547 development program in postpartum depression," said Jeff Jonas, M.D., Co's CEO. "Based on our meeting, we have clear and efficient direction for the expedited development path forward for SAGE-547 to potentially support a New Drug Application (:NDA) in 2018."

7:04 am AcelRx reports market expectations and commercial plans for ARX-04 from Analyst & Investor event on December 1 (ACRX) :

  • "The event provided an opportunity for AcelRx and several key opinion leaders to share their outlook for ARX-04," commented Howie Rosen, chief executive officer of AcelRx. "The underlying theme of overcrowding in emergency rooms combined with a non-invasive sublingual approach to the treatment of moderate-to-severe acute pain resonates with practicing physicians. We look forward to the submission of the NDA later this month and in working with the FDA on its review of ARX-04."

7:04 am Mateon Therapeutics presents data from its on-going phase 1b OX1222 study of OXi4503 in combination with cytarabine in patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome at ASH 2016 (MATN) :

  • The first cohort enrolled 6 patients at a dose of 3.75 mg/m2 of OXi4503 in combination with an intermediate dose (1g/m2/day x 5 days) of cytarabine. The second cohort enrolled 4 patients at a dose of 4.68 mg/m2 of OXi4503 in combination with the same intermediate dose of cytarabine. Patients enrolled into OX1222 were treatment-resistant, end-stage AML/MDS patients who had on average four prior therapy failures before entering the study.
  • In total 2 of 10 (20%) patients achieved a complete remission (CR) on treatment and currently remain in CR without further treatment -- one at 6 months and the other at 3 months. One patient of six (17%) responded in the 3.75 mg/m2 dose cohort, and one patient of four (25%) responded in the 4.68 mg/m2 dose cohort. The study is currently enrolling patients in the third cohort at 6.25 mg/m2 of OXi4503.
  • OXi4503 was generally well tolerated in the first two cohorts of the study. The adverse event profile remains similar to that seen in the monotherapy Phase 1b portion of the trial, with coagulopathies and hematological adverse events the most significant events. The most common drug-related SAEs were anemia (30%), neutropenia (30%), D-dimer increase (20%), thrombocytopenia (20%), and AST increase (20%). One patient in the 3.75 mg/m2 cohort experienced a dose-limiting toxicity of hypofibrinogenemia with no clinical evidence of bleeding, which resolved with treatment.

7:03 am Spectrum Pharma at ASH: Case match control analysis of Propel reveals survival advantage for patients with relapsed/refractory (R/R) peripheral t-cell lymphoma (:PTCL) treated with Pralatrexate (SPPI) :

Co announced the presentation of data from a case match control analysis of the PROPEL Study in a poster presentation session at the 58th American Society of Hematology (ASH).

In this retrospective, observational study, 80 patients out of 109 treated on the PROPEL study were successfully matched 1:1 with the control population. A highly significant difference in the Overall Survival between the control population and the pralatrexate group was observed. The overall survival observed in the control population was 4.04 months (95% CI 2.60, 6.01) which was consistent with historical controls, while the median OS in for pralatrexate treated cohort was 14.78 months (95% CI 10.61-22.31). The most common adverse reactions from the PROPEL study were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

  • "FOLOTYN was the first drug approved for the treatment of relapsed or refractory PTCL and continues to have the leading market share in 2nd line therapy. PTCL is an aggressive disease with a poor prognosis and we are excited that FOLOTYN has the potential to improve outcome for PTCL patients. We are also looking forward to emerging new data in combination treatments that might prove to benefit PTCL patients in earlier lines of treatment and with the possibility to include FOLOTYN in future PTCL first line regimens."

7:03 am Codexis enters into an exclusive agreement with Tate & Lyle to supply a proprietary enzyme for use in the company's food ingredient production (CDXS) : "We are delighted to move our partnership with Tate & Lyle to the commercial level," said Codexis President and CEO John Nicols. "This agreement further validates the ability of our CodeEvolver protein engineering platform technology to improve and support manufacturing processes, in this case in the food industry. Expanding application of our technology to new markets has been a strategic priority for Codexis and establishing this agreement is a notable achievement."

7:02 am KKR to acquire a majority stake in Optiv from a group of private investors, including a private equity fund managed by Blackstone (BX); financial terms not disclosed (KKR) :

Optiv Security is a provider of end-to-end cyber security solutions.

  • The company is being acquired from a group of private investors, including a private equity fund managed by Blackstone (BX).
  • Other selling shareholders include Investcorp and Sverica.
  • Financial terms of the transaction are not being disclosed.

7:02 am Neovasc provides an update on the clinical experience with its Tiara transcatheter mitral valve (NVCN) :

Co provided an update on the clinical experience with its Tiara transcatheter mitral valve. Tiara is a novel transcatheter device designed to treat mitral regurgitation (:MR), a condition that is often severe and can lead to heart failure and death.

  • To date, 22 patients have been treated with the Tiara valve at medical centers in Canada, the U.S. and Europe with more implantations scheduled for the coming weeks. The technical success rate in these implantations was 19/22 or 86%. In these technically successful implantations, paravalvular leak levels were reported as mild, trace or absent in 100% of these cases.
  • All cause 30-day mortality in the 19 patients who have reached 30 days post implant with Tiara is 15.7% (3/19).
  • The 3 remaining patients treated within the last 30 days are recovering well.
  • Of note, there has been no 30-day mortality reported in any of the last 8 patients treated over a month ago.
  • To date, the longest patient follow up available is nearing 3 years post implant, where the Tiara valve remains fully functional.
  • There have been no reported adverse events related to the valve performance.
  • TIARA II, a 115 patient, non-randomized, prospective clinical study evaluating Tiara's safety and performance, recently received approval to begin enrolling patients in Italy. It is expected that data from this study will be used to file for CE Mark approval for Tiara.

7:02 am AutoZone beats by $0.04, reports revs in-line (AZO) :

  • Reports Q1 (Nov) earnings of $9.36 per share, $0.04 better than the Capital IQ Consensus of $9.32; revenues rose 3.9% year/year to $2.47 bln vs the $2.49 bln Capital IQ Consensus. 
    • For the quarter, gross profit, as a percentage of sales, was 52.7% (versus 52.5% for the same period last year). The improvement in gross margin was attributable to lower acquisition costs, partially offset by higher supply chain costs associated with current year inventory initiatives (-14 bps).
    • Operating expenses, as a percentage of sales, were 34.1% (versus 34.2% the same period last year). Operating expenses, as a percentage of sales, were relatively flat to last year as favorability across several areas was offset by higher domestic store payroll (-9 bps).
    • AutoZone repurchased 478 thousand shares of its common stock for $363 million during the first quarter, at an average price of $759 per share. At the end of the first quarter, the Company had $783 million remaining under its current share repurchase authorization.

7:01 am Immunomedics announces that IMMU-140 'demonstrated a significant antitumor effect without any undue toxicity in four hematopoietic tumors in preclinical studies' at ASH 2016 (IMMU) :

  • IMMU-140 comprises the humanized antibody, IMMU-114, conjugated to the moderately-toxic drug, SN-38, through the co's proprietary linker, CL2A, the same toxic payload and antibody-drug linker that are in sacituzumab govitecan. The latter ADC has produced encouraging results in a Phase 2 study in patients with metastatic triple-negative breast cancer and has been designated a Breakthrough Therapy by the FDA for TNBC patients who have received at least two prior therapies for their late-stage disease.
  • The goal of this preclinical study was to determine if SN-38, a drug not commonly used in liquid malignancies, would prove to be an effective and safe therapeutic when targeted with the IMMU-114 antibody, which could then improve the antitumor activity of IMMU-114.
  • When given subcutaneously, it has encouraging efficacy in a Phase 1 first-in-man study in patients with advanced, relapsed, non-Hodgkin lymphoma and chronic lymphocytic leukemia, with a good safety profile. In contrast, acute myelocytic leukemia, despite high expression levels of HLA-DR, has proven to be resistant to the antitumor effects of IMMU-114 in vitro. As a result, AML, along with acute lymphocytic leukemia and multiple myeloma, continue to be a therapy challenge.
  • Mice bearing human MM had a median survival time that was about a 60% improvement when compared to IMMU-114 therapy. In CLL, both IMMU-140 and IMMU-114 produced a similarly improved MST. Therapy with IMMU-140 was well tolerated by the mice with no appreciable loss in body weight.

7:01 am Buckle's Board authorizes $0.75/share special cash dividend (BKE) : (2015 declared special dividend $1/share, 2014 was $2.77/share)

7:01 am Bio-Path reviews BP1001 data as a treatment for chronic myelogenous leukemia at ASH 2016; results demonstrate BP1001 decreased the proliferation of Gleevec (imatinib)-resistant CML cells in a dose-dependent manner (BPTH) :

  • BP1001 is a neutral-charge liposome-incorporated antisense drug designed to inhibit protein synthesis of Grb2.
  • The results demonstrated that BP1001 decreased the proliferation of Gleevec (imatinib)-resistant CML cells in a dose-dependent manner. In addition, BP1001 pretreatment enhanced the inhibitory effects of Sprycel in CML cells, leading to cell death. Five CML blast phase patients were enrolled in the first cohort (5 mg/m2 BP1001) of the Phase 1 BP1001 clinical study. Two CML patients, who had T315I mutation, showed significant reductions in circulating blasts during treatment. One patient's blasts were reduced from 89% to 12%, while another patient's blasts were reduced from 24% to 7%.

7:00 am IntraLinks Holdings to be acquired by Synchronoss Technologies (SNCR) for $13.00/share in cash, or approximately $821 mln (IL) :

Synchronoss Technologies (SNCR) and Intralinks announced that they have entered into a definitive agreement for Synchronoss to acquire Intralinks for approximately $821 million in equity value. Under the terms of the agreement, Synchronoss will commence a cash tender offer to acquire all of the outstanding common stock of Intralinks for $13.00 per share. The transaction, which was unanimously approved by the board of directors of both companies, is expected to close late in the first calendar quarter of 2017, subject to customary closing conditions. Ron Hovsepian, Chief Executive Officer of Intralinks, is expected to be appointed Chief Executive Officer of Synchronoss and join the Synchronoss Board of Directors upon closing of the transaction with Synchronoss' Founder and current Chief Executive Officer, Stephen G. Waldis will move into the role of active Executive Chairman of the Board.

  • In conjunction with today's announcement Synchronoss is also announcing an agreement to divest a portion of its activation business to Sequential Technology International, LLC for a total purchase price of $146 million. As part of this transaction, Sequential Technology will purchase 70% of Synchronoss' carrier activation business that is being divested, with Synchronoss retaining a 30% ownership piece which could be reduced during the course of 2017. Synchronoss is in the process of pursuing strategic alternatives for the remaining activation business assets.
  • Given the expected closing in the first calendar quarter of 2017, Synchronoss expects the Intralinks transaction to have no impact to its fourth quarter financials. With the impact from the Sequential Technology divestiture and assuming a late first quarter 2017 close on the Intralinks deal, Synchronoss is giving initial 2017 revenue guidance of between $810 million and $820 million [May not compare to the $818.48 mln Capital IQ Consensus Estimate] with pro forma EPS of between $2.45 and $2.60 for the combined entity [May not compare to $3.11 Capital IQ Consensus Estimate]. The co is targeting $40 million of combined synergies within the first year of closing the Intralinks deal.
  • Synchronoss expects to finance the Intralinks acquisition with its existing cash, proceeds from the Sequential Technology transaction, and $900 million of new debt.

6:56 am Roper to acquire Deltek in an all cash transaction valued at $2.8 billion; accretive, expected to add $80 million to 2017 free cash flow (ROP) :

  • Deltek is the leading global provider of software and information solutions for project-based businesses serving niche markets, including government contractors and professional services firms.
  • The transaction is expected to be accretive to Roper's 2017 cash flow.
    • Including estimated financing costs, the acquisition is expected to add $80 million to Roper's 2017 free cash flow.
    • Roper expects Deltek to deliver $535 million of revenue and $200 million of EBITDA in 2017, excluding the impact of fair value accounting of Deltek's deferred revenue.
    • The Company expects the transaction to have limited impact on 2017 EPS due to non-cash amortization expense, the extent of which has not yet been determined.
  • The transaction is expected to close prior to the end of this year. 
  • Conference Call to be held at 9:00am ET today

6:53 am Bank of Montreal beats by CAD$0.25, beats on revs; raises dividend 2% Q/Q to CAD$0.88 (BMO) :

  • Reports Q4 (Oct) earnings of CC$2.10 per share, excluding non-recurring items, CC$0.25 better than the Capital IQ Consensus of CC$1.85; revenues rose 5.9% year/year to CC$5.28 bln vs the CC$5.13 bln Capital IQ Consensus. Return on equity was 13.8% and adjusted return on equity was 14.4%.
  • Book value per share increased 6% from the prior year to $59.56 per share. The Common Equity Tier 1 Ratio was 10.1%.
  • Provisions for credit losses of $174 million, compared with $128 mln due to higher provisions in Canadian and U.S. P&C and lower net recoveries in Corporate Services.
  • BMO announced a first quarter 2017 dividend of $0.88 per common share, up $0.02 or 2% from the preceding quarter

6:52 am Genesco to sell its SureGrip Footwear subsidiary to Shoes for Crews; terms not disclosed (GCO) :

  • SureGrip markets a broad line of occupational, slip-resistant footwear at a range of price points for the hospitality, grocery, foodservice, healthcare and industrial industries under a portfolio of well-known brands including New Balance, Caterpillar, Dockers, Lila, Merrell, Aerosoles, Crocs, DC Shoes, Johnston & Murphy and Keuka. Like SFC, SureGrip products are distributed both through corporate safety footwear programs as well as direct-to-consumer.
  • The transaction is expected to close by the end of 2016.

6:50 am Asian Markets Close: Nikkei +0.5%, Hang Seng +0.8%, Shanghai -0.2% (:SUMRX) :

Equity indices in the Asia-Pacific region ended Tuesday on a higher note. Press reports from Japan indicated the country may issue mid-year deficit bonds, marking the first such issue since 2009. The Reserve Bank of Australia kept its key interest rate at 1.5%, as expected. The People's Bank of China strengthened the yuan fix to mid-November levels.

  • In economic data:
    • Japan's Average Cash Earnings +0.1% year-over-year (consensus 0.2%; last 0.0%) and October Overtime Pay -1.4% year-over-year (last -1.3%)
    • Australia's Q3 Current Account deficit narrowed to AUD11.40 billion from AUD15.90 billion (expected deficit of AUD13.70 billion)

---Equity Markets---

  • Japan's Nikkei added 0.5% with seven sectors ending in the green. Utilities (+2.3%), materials (+1.9%), and financials (+1.7%) outperformed while consumer staples (-0.6%) and health care (-0.4%) lagged. SUMCO, Kobe Steel, Mitsubishi Materials, Casio Computer, Isuzu Motors, and Panasonic gained between 2.8% and 5.5%.
  • Hong Kong's Hang Seng climbed 0.8% with financials ending among the leaders. China Life Insurance, HSBC, ICBC, BoC Hong Kong, Bank of China, and Hang Seng Bank gained between 1.1% and 3.6%.
  • China's Shanghai Composite shed 0.2%. China Eastern Airlines fell 3.0% while Aluminum Corp of China, Jiangxi Copper, Orient International, and China Sports Industry Group lost between 3.0% and 4.2%.
  • India's Sensex added 0.2%. Housing Development Finance gained 2.1% while Tata Steel, SBI, Reliance Industries, Infosys, and Wipro gained between 0.6% and 1.2%. Hindustan Unilever was the weakest performer, falling 1.2%.

---FX---

  • USDJPY +0.1% to 113.97
  • USDCNY UNCH at 6.8804
  • USDINR -0.2% to 67.851

6:49 am At Home Group beats by $0.01, beats on revs; raises FY17 EPS in-line, raises rev, comp guidance (HOME) :

  • Reports Q3 (Oct) adj. earnings of $0.03 per share, $0.01 better than the Capital IQ Consensus of $0.02; revenues rose 22.5% year/year to $170.7 mln vs the $165.63 mln Capital IQ Consensus. 
    • Comparable store sales increase of 4.2%.
  • Co issues guidance for FY17, sees EPS of $0.54-0.57 (from $0.53-0.56), excluding non-recurring items, vs. $0.55 Capital IQ Consensus Estimate; raises FY17 revs to $750-758 mln from $738-750 mln vs. $747.67 mln Capital IQ Consensus; net sales growth outlook is based on 23 net new store openings and an assumed comparable store sales increase of 2.5% to 3.0% from +1.5-2.0%. "As a result of our strong third quarter performance and fourth quarter momentum, we are increasing our fiscal 2017 top and bottom line expectations. For the full year, we now expect to achieve 20% to 22% net sales growth, an ~six-fold increase in net income, and a 34% to 40% increase in pro forma adjusted net income."  
  • "We are pleased to report strong third quarter results driven by broad-based strength across both new and existing stores. Our differentiated, value-oriented product offering resonated with our customers and, combined with the progress we are making on our merchandising and marketing initiatives, drove our tenth consecutive quarter of over 20% net sales growth and our eleventh consecutive quarter of positive comparable store sales growth."

6:48 am Pentair increases quarterly cash dividend to $0.345/share from $0.34/share (PNR) :  

6:31 am CEMEX announces progress towards initiatives to regain an investment-grade capital structure; 'well on track' to reach its debt reduction target of $3-3.5 bln by the end of 2017 (CX) :

  • The co will be able to meet its $1.5-$2 bln 2017 asset disposal target ahead of schedule.
  • With the proceeds from asset divestments, as well as free cash flow generation and cash on hand, CEMEX has reduced total debt plus perpetual securities by more than $2 bln year to date, in line with this year's target. Taking into account this reduction in debt, as well as expected additional debt payments before year end, CEMEX is on target to reach its leverage ratio target of about 4.25 times by the end of this year.
  • With the proceeds from pending asset divestments, as well as continued favorable free cash flow generation, CEMEX is also well on track to reach its debt reduction target of $3 to-$3.5 bln by the end of 2017.
  • The co is also currently on course to reach its initiatives to increase free-cash-flow by U.S.$670 mln by the end of this year. In addition, the company expects to meet its cost-and-expense reduction target of $150 mln which has contributed to CEMEX's improvement in profitability during 2016.
  • The co has enlarged its revolving credit facility and now has no significant maturities until Mar 2018.

6:31 am Noble Midstream Partners provides Q4 guidance for Oil and Gas gathering volumes of 62 - 65 thousand MBoe/d and EBITDA of $36-40 million, or attributable to the Partnership of $26-29 million (NBLX) :

4Q16 Guidance

  • Oil and Gas gathering volumes of 62 -- 65 thousand barrels of oil equivalent per day (MBoe/d)
  • Produced water gathering volumes of 10 -- 12 thousand barrels of water per day (MBw/d)
  • Fresh water delivery volumes of 125 -- 150 (MBw/d)
  • Net Income of $34 - $37 million
  • EBITDA(1) of $36 - $40 million, or attributable to the Partnership of $26 - $29 million
  • Distributable Cash Flow (1) of $24 - $27 million

Co states, "We are pleased with the operational momentum that has carried over from the third quarter when new volumetric records were set in all segments. The business continues to significantly exceed our IPO forecast and activity levels on dedicated acreage are already ahead of our expectations."

6:31 am Matador Resources prices 6,000,000 shares at $24.65/share (MTDR) :  

6:30 am Acasti Pharma announces proposed offering of units (ACST) : The co announced that it has received a receipt for a preliminary short form prospectus in connection with a proposed offering of units of Acasti for minimum gross proceeds of CAD$6,500,000 and maximum gross proceeds of CAD$10,000,000. If the Minimum Offering is completed, the Corporation intends to use the net proceeds from the Offering to fund its operations through December 31, 2017 to complete its manufacturing scale-up and the planning for the Phase 3 clinical trial for CaPre, Acasti's lead product candidate.

6:23 am Airbus booked 15 orders for its single-aisle and widebody jetliners during November (EADSY) :

  • Airbusbooked 15 orders for its single-aisle and widebody jetliners during Novemberwhile making 61 deliveries involving all members ofits current-production product line: the A320 Family, A330, A350 XWB and A380.

6:22 am Daimler AG's Mercedes-Benz unit increased its worldwide unit sales in November by 12.7% to 182,602 vehicles (DDAIF) :

  • Unit sales by Mercedes-Benz in Europe increased by 16.7% to 78,797 vehicles -- never before so many cars have been delivered to customers in a November as this year. In Germany, demand for Mercedes-Benz automobiles increased last month to 25,599 units (+7.2%).

6:19 am Clean Energy Fuels announces two new fueling station construction projects and multiple projects for its Facility Modification Services, including three for Cummins Inc.'s (CMI) Sales and Service business (CLNE) :  

6:10 am HD Supply Holdings reports Q3 earnings and revs in-line with Nov 9 preannouncement; guides Q4 EPS in-line, revs in-line (HDS) :

  • Reports Q3 (Oct) earnings of $0.83 per share, $0.01 better than the Capital IQ Consensus of $0.82, and in-line with co's pronouncement in which co expected Q3 adj. EPS of $0.82-0.83; revenues rose 3.4% year/year to $2.01 bln vs the $2.01 bln Capital IQ Consensus.
    • Revs were in-line with pre-announcement on Nov 9, where prelim Q3 net sales of $2,008 mln
  • Co issues in-line guidance for Q4, sees EPS of $0.38-0.46 vs. $0.41 Capital IQ Consensus Estimate; sees Q4 revs of $1.61-1.67 bln vs. $1.64 bln Capital IQ Consensus Estimate.
  • Preliminary November Sales Results
    • Preliminary Net sales in November were ~$526 million, which represents YoY average daily sales growth of ~2.3%.
    • Preliminary November YoY average daily sales growth by business was Facilities Maintenance ~0.9%, Waterworks ~2.9% and Construction & Industrial ~3.8%.
    • There were 18 selling days in November 2016 and 18 selling days in November 2015.

6:10 am Conn's beats by $0.11, misses on revs; Q3 same store sales -10.1% (CONN) :

  • Reports Q3 (Oct) loss of $0.08 per share, excluding non-recurring items, $0.11 better than the Capital IQ Consensus of ($0.19); revenues fell 4.7% year/year to $376.8 mln vs the $392.61 mln Capital IQ Consensus. 
  • "As a result of the rollout, all of November's Texas originations were under the direct loan program, which improved the APR on new originations to over 27%, an increase in excess of 500 basis points compared to September. We expect the direct loan program, planned changes in other states, and changes to no-interest programs will increase Conn's overall yield by 600 to 900 basis points on new originations by the end of fiscal 2018,"
  • "The recent enhancements to our underwriting model affected the third quarter's same store sales by ~1,000 basis points and were the primary drivers of the 10.1% reduction in same store sales [vs. guidance for a high single digit decline]. Retail Gross Margin Strengthened 40 Basis Points Sequentially to 37.5% [vs. 36.5-37.25%]."
  • "Conn's retail operation continues to perform well despite the significant impact underwriting refinements have had on sales. During the fiscal 2017 third quarter, retail gross margins improved 40 basis points from both fiscal 2017 second quarter and fiscal 2016 third quarter levels."
  • The following are the Company's expectations for the business for the fourth quarter of fiscal 2017: Change in same store sales down approximately 10.0%; Retail gross margin between 37.0% and 37.5% of total net sales; Provision for bad debts between 16.75% and 17.75% of the average total customer portfolio balance (annualized).

6:05 am Photronics beats by $0.02, reports revs in-line; guides Q1 EPS, revs in-line (PLAB) :

  • Reports Q4 (Oct) earnings of $0.05 per share, excluding non-recurring items, $0.02 better than the Capital IQ Consensus of $0.03; revenues fell 24.2% year/year to $107.37 mln vs the $106.98 mln Capital IQ Consensus. As a reminder, the company pre-announced results in early November
    • "Demand for our products fell during the quarter as many of our customers decreased new design activity, reducing the demand for new photomasks, especially at the high end. High end FPD remains soft as the industry transitions from LCD to OLED, temporarily reducing new design activity. High end IC memory is starting to see pricing recovery, driving new design activity but not yet impacting mask demand. High end IC logic, which can be volatile, was down this period. Net income fell due to the lower sales level, but we were able to offset some of the decline by reducing our operating expenses."
  • Co issues in-line guidance for Q1, sees EPS of $0.01-0.06 vs. $0.03 Capital IQ Consensus Estimate; sees Q1 revs of $104-112 mln vs. $107.69 mln Capital IQ Consensus Estimate.
    • "While we believe our end market demand will improve in 2017, we don't anticipate any meaningful improvement during the first quarter. Markets should basically remain level with fourth quarter demand, with potential tailwinds from high-end logic offset by seasonal softness from Christmas and Chinese New Year holidays."

6:03 am GoDaddy acquires Host Europe Group for $1.79 bln; intends to explore strategic alternatives for the PlusServer biz (GDDY) :

  • GoDaddy to acquire Host Europe Group for EUR 1.69 bln ($1.79 bln), including EUR 605 mln paid to the selling shareholders and EUR 1.08 bln in assumed net debt. The transaction has been approved by the GoDaddy board of directors and HEG's shareholders and is expected to close in the second quarter of 2017.
  • HEG is currently owned by Cinven, one of Europe's leading private equity firms, which acquired the business in Aug 2013. GoDaddy intends to integrate the majority of HEG's business while exploring strategic alternatives for HEG's PlusServer managed hosting business, including a possible sale.
  • HEG has reported consistently strong top line and cash flow growth and is on track to generate approximately US$328 mln in bookings and ~$139 mln in adj EBITDA in 2016. The purchase price of EUR 1.69 bln ($1.79 bln), represents ~11x HEG's 2016 estimated adj EBITDA including anticipated annual synergies.
  • Because its business model differs from GoDaddy, GoDaddy intends to explore strategic alternatives for the PlusServer biz, which is expected to generate approximately $92 mln in bookings and $41 mln in adj EBITDA in 2016.
  • GoDaddy will host a conference call and webcast to discuss the acquisition at 8:00 am ET on Dec 6, 2016.

6:03 am Reata Pharmaceuticals files a registration statement on Form S-1 for an underwritten public offering of shares of its Class A common stock (RETA) : Co intends to use the net proceeds from the offering to advance the development of its lead product candidate, bardoxolone methyl, through a Phase 2/3 trial and additional Phase 2 programs, to advance the development of its additional lead product candidate omaveloxolone, and to provide funds for working capital and other general purposes, including clinical trials and preclinical studies.

6:02 am Mesoblast announces that MD Anderson Cancer Center and NIH will fund a clinical trial combining its Mesenchymal Precursor Cell-based expansion and ex-vivo fucosylation of hematopoietic stem cells for cord blood transplantation in cancer patients (MESO) : The new trial of up to 25 patients, entitled 'Cord Blood Ex-vivo MPC Expansion Plus Fucosylation to Enhance Homing and Engraftment', is supported by a grant from the NIH National Cancer Institute (NCI Grant R01 CA061508-19) and will be led by Dr Amanda Olson, Assistant Professor, Department of Stem Cell Transplantation and Dr Shpall at MDACC. If the results of the combination study are positive, Mesoblast's proprietary ex vivo-fucosylation technology may be incorporated into the company's Phase 3 program of MPC-expanded HSCs.

6:02 am Medtronic announces their Endurant II/IIs Stent Graft System Receives CE Mark for use with chevar parallel graft technique (MDT) :

  • This expanded indication in the European Union enables the Endurant II/IIs stent graft system to be used in patients with complex aneurysms with short aortic neck lengths >=2 mm, expanded from the prior neck length indication >=10 mm.
  • The CE Mark is supported by a comprehensive review of clinical data fromliterature using the Endurant II/IIs stent graft system with the ChEVARtechnique. In the flagship PROTAGORAS study, outcomes were tracked withradiologic follow up over a mean of two years. The study used a standardizedprocedural approach with the Endurant system and balloon expandable coveredstents.
    • The results, which were published in the Journal of Vascular Surgery,demonstrated that standardized use of the Endurant II/IIs stent graft systemwith ChEVAR in 128 patients is associated with 100 percent technical success,statistically significant aneurysm sac regression (p = .001), 95.7 percentprimary patency of the chimney grafts and a low incidence of chimney relatedreinterventions.(1,2)

5:58 am Shanghai...-0.16% (FXI) :  

5:58 am S&P futures vs fair value: +0.20. Nasdaq futures vs fair value: +4.30. :

5:58 am European Markets : FTSE...6734.82...-12.00...-0.20%.  DAX...10691.85...+7.00...+0.10%.

5:58 am Asian Markets : Nikkei...18360.54...+85.60...+0.50%.  Hang Seng...22675.15...+169.60...+0.80%.

5:47 am Petrobras Brasileiro receives injunctions to suspend the divestment processes of the interest of its subsidiary BR Distribuidora (PBR) :

Co informs that becameaware of two decisions of the federal court of Sergipe state that grantedinjunctions in actions to suspend the divestment processes of the interest ofits subsidiary BR Distribuidora and of the transfer of rights of oil andnatural gas exploration, development and production of a set of onshorefields.

  • Petrobras will appealthese injunctions and clarifies that these processes are being conducted incompliance with the stages laid down in the Divestment System, guaranteeingextensive competition among potential interested parties, as a means ofensuring the best deal for the Company.
  • Furthermore, thedivestment processes of Petrobras are analyzed by various internal committeesand submitted to the competent bodies for approval of the transactions.

5:35 am On The Wires (:WIRES) :

  • Novogen (NVGN) enrolled the first patient into its firstin-human, phase I clinical study for Cantrixil in ovarian cancer. Opening the study represents an important clinical and commercial milestone for Novogen. It is anticipated that up to 60 patients will be recruited and the study will run for ~18 months.
  • Thomas Cook Group (TCKGY) will take full control of its UK retail store network, following notification by The Co-operative Group of the decision to exercise its option over its stake in their Joint Venture. Thomas Cook will purchase The Co-operative Group's 30 per cent stake and Central England Co-operative's 3.5% stake for 50.0 million and 5.8 million, respectively, in cash. Following completion, which is expected in November 2017, Thomas Cook will own 100% of the UK retail stores business.
  • Toyota Motor (TM), in pursuit of superb driving and environmental performance, and based on the Toyota New Global Architecture structural reform, has developed advanced engines and transmissions and further evolved its hybrid systems. Toyota intends to deploy these new powertrain units in a rapidly broadening range of vehicle models, starting in 2017.

5:08 am Affimed Therapeutics reports New preclinical data on Bi-and Trispecific immune cell engagers; AFM13 showed combination with IL-2 or IL-15 had a synergistic effect on AFM13-mediated expansion (AFMD) :

Co announced the presentation of preclinical data from three studies at ASH

  • AFM13 - In summary, the data presented at ASH demonstrates that AFM13 specifically enhances the cytotoxic, proliferative and cytokine-producing potential of NK-cells. In addition, the results indicate that the distinctive modulation of NK-cell receptors can be utilized to monitor NK-cell responses during AFM13 therapy and to select candidates for therapeutic combination strategies.
  • AFM11 - In summary, T-cell-engaging immunotherapies such as bispecific T-cell-recruiting antibodies or chimeric antigen receptor T-cells (CAR-T) have emerged as highly active therapeutics in hematological malignancies and these results highlight the importance of taking the specifics of chemotherapeutic pretreatment into account in the planning of immuno-oncology trials.
  • Trispecific Antibodies - Due to its largely tumor cell-specific expression profile, B-cell maturation antigen (BCMA/CD269) has emerged as a promising target antigen for antibody-based therapies of MM. CD200 was selected as the second MM-expressed surface antigen found in the majority of patients. In vitro, the trispecific antibodies selectively engaged NK-cells through bivalent binding to CD16A and monovalent binding to both BCMA and to CD200. Binding to BCMA+/CD200+ cells and the resulting increase in avidity led to preferential lysis of antigen double-positive cells compared with antigen single-positive cells. These data suggest that dual-targeting may increase the therapeutic window compared to approaches targeting only one antigen.

5:03 am AstraZeneca reports Phase III trial of Tagrisso; demonstrates superiority over chemotherapy (AZN) :

Co presented data from the AURA3 trial that is supportive of Tagrisso potentially becoming the new standard of care for 2nd-line treatment of patients with epidermal growth factor receptor T790M mutation-positive locally-advanced or metastatic non-small cell lung cancer.

  • The first randomised Phase III data showed that Tagrisso 2nd-line therapy improved progression-free survival by 5.7 months compared with standard platinum-based doublet chemotherapy
  • AURA3 data showed Tagrisso offered a statistically-significant improvement in PFS versus standard platinum-based doublet chemotherapy
  • In the 34% of patients with central nervous system metastases at baseline, PFS was also significantly greater with Tagrisso than with platinum-based doublet chemotherapy
  • The AURA3 safety data for Tagrisso were in line with previous experience.

4:54 am Electricite de France divests 100% of EDF DMSZ (ECIFY) :

E.D.F. International SAS signed with the ENKSZ First National Public Utility Elso Nemzeti Kzmuszolgltat Zrt, a 100% Hungarian state-owned company, a definitive agreement for the sale of the whole of its stake in EDF DMSZ Zrt.

  • The EDF DMSZ Group provides and distributes electricity to 775,000 retail and business customers and operates 32,320 kilometers of network lines in the South- east Hungary region.
  • EDF DMSZ Zrt. operates directly under four licenses: Universal Service Provider, Open Market trader, natural gas commerce and public lightening operation, and indirectly through its subsidiary named EDF DMSZ Hlzati Eloszt Kft. under a distribution licence.
  • Completion of the transaction is subject to merger control clearance in Hungary and the consent of the Hungarian Energy and Public Utility Regulator. Authorization by the French Ministry of Economy is also required.

4:34 am Novartis reports first-line study results for Zykadia; demonstrates 45% reduction in the risk of disease progression (NVS) :

Co announced results from its Phase III open-label, randomized,active-controlled, multi-center ASCEND-4 study, which found that patients withanaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer treated with first-line Zykadia had amedian progression-free survival of 16.6 months, compared to 8.1 months in patients treated withstandard first-line chemotherapy with maintenance. This equated to a45% reduction in the risk of disease progression

  • Overall survival data, a key secondary endpoint of the study, are immature; however, a positive trend in favor of Zykadia was observed, despite 72.4% of patients in the chemotherapy arm receiving an ALK inhibitor as their first treatment after discontinuing chemotherapy. Pre-specified secondary endpoints demonstrating the efficacy of Zykadia in ALK+ advanced NSCLC patients included overall response rate (:ORR), overall intracranial response rate (:OIRR), disease control rate (:DCR) and duration of response (DoR). 
  • Patients taking Zykadia had an ORR of 72.5% compared to 26.7% in patients treated with standard chemotherapy.
  • Further, patients with measurable brain metastases experienced an OIRR of 72.7% with Zykadia compared to 27.3% with standard chemotherapy. Patients without brain metastases at screening experienced a median PFS of 26.3 months with Zykadia compared to 8.3 months with standard chemotherapy.
  • Additionally, patients taking Zykadia demonstrated a DCR of 84.7% and DoR of 23.9 months
  • Study results were measured by a blinded independent review committee.
  • Patients treated with Zykadia also reported better overall general health status and improvement in lung cancer-specific symptoms compared to patients treated with standard chemotherapy

4:22 am On The Wires (:WIRES) :

  • Clavister (CLAV) announced that NTTBP, Japanese provider of carrier grade Wi-Fi service, highly customized Wi-Fi services for transportation facilities, vehicles, convenience stores and local government, high-density WiFi in studiums and convention centers, and value added services, and a group company of NTT Group has selected Clavister and its integrator partner MIRAIT to implement security on NTTBP's extensive public Wi-Fi network which has over 220,000 access points across Japan.
  • TSYS (TSS) announced that it has renewed its payments agreement with Advanzia Bank S.A., the largest issuer of credit cards in Luxembourg, to continue processing the bank's consumer credit card portfolio. TSYS will also provide additional services such as fraud and risk management, verification and contactless card support.
  • Philip Morris International (PM) on Dec. 5 submitted a Modified Risk Tobacco Product application for its electronically heated tobacco product with the FDA Center for Tobacco Products. This is consistent with the company's stated goal of submitting its MRTP application in 2016. PMI anticipates the FDA taking a minimum of 60 days to complete an administrative review to determine whether to accept the application for substantive review.
  • Eurofins Scientific (ERFSF) announced that it has acquired Exova's environment testing business in Eastern Canada for about CAD13 mln. The acquired business includes 5 laboratories in Quebec and Ontario, employing about 160 staff, and generated around CAD19 mln of revenues in 2015.

4:18 am CNinsure to change company name to Fanhua Inc; changes Nasdaq ticker symbol to FANH (CISG) :

4:16 am Inogen announces Scott Wilkinson to succeed Raymond Huggenberger as CEO effective Mar 1, 2017; reiterates 2016 and 2017 guidance (INGN) :

Co announced that its Board of Directors has appointed Scott Wilkinson as Inogen's President and Chief Executive Officer, effective March 1, 2017. Mr. Wilkinson
will also join the Board of Directors on January 1, 2017.

  • Wilkinson will succeed Raymond Huggenberger, who is retiring as Chief Executive Officer, effective March 1, 2017.
    • Wilkinson currently oversees Inogen's global commercial, manufacturing, service, research and development, technical and support operations.

Financial Outlook for 2016 and 2017

  • Co reaffirms guidance for FY16 (Dec), sees FY16 (Dec) revs of $194-198 mln vs. $198.20 mln Capital IQ Consensus Estimate.
    • Inogen is reiterating its 2016 net income estimate range of $12.5 to $14.5 million
    • Inogen is also reiterating its expectation for net positive cash flow for 2016 with no additional equity capital required to meet its current operating plan
  • Co reaffirms guidance for FY17 (Dec), sees FY17 (Dec) revs of $230-236 mln vs. $234.60 mln Capital IQ Consensus Estimate.
    • Inogen is reiterating net income and Adjusted net income estimate of $16 to $18 million
    • Inogen is reiterating its guidance range for Adjusted EBITDA of $45 to $49 million
    • Inogen also continues to expect net positive cash flow for 2017 with no additional equity capital required to meet its current operating plan.

4:11 am On The Wires (:WIRES) :

  • Nidec (NJDCY) announced that the Company has acquired full ownership of Canton Elevator, Inc, a privately owned US company, from its owners through the Company's subsidiary, Nidec Motor Corporation based in St. Louis, MO on Dec 5. As a result of the Transaction, Canton became a consolidated subsidiary of Nidec. Terms were not disclosed. Canton Elevator had Sales of $33.7 mln in FY15
  • CGG (CGG) announced the delivery of near real-time imaging results for a 4,200 sq km BroadSeis 3D marine seismic survey acquired offshore Morocco. CGG delivered the very-fast-track RTM PSDM volume to the client only 4 days after the last shot. This technical feat crowned an excellent operational performance by the crew of the CGG Geo Caspian who worked in a safe, collaborative and effective partnership with the client to complete the program ahead of schedule.
  • Cognizant (CTSH) announced the expansion of its operations in the Kingdom of Saudi Arabia with the opening of a new office in Riyadh.
  • BroadSoft (BSFT) announced the commercial availability of BroadSoft UC-One Conference Room -- a one-click conference room system experience that enables businesses to easily and affordably connect existing conference rooms to any UC-One virtual conference.
  • Total (TOT) has been awarded exploration licenses on 3 Blocks in offshore Mexico, following the country's first competitive deep water bid round. Total will be operator of Block 2 in the Perdido basin with a 50% interest, while ExxonMobil (XOM) has the remaining 50%. The block covers a surface area of 2,977 sq km at water depths ranging from 2,300 to 3,600 meters. In the Salina basin, Total has won a participating interest of 33.3%, alongside Statoil ((STO) - 33.4%) and BP (33.3%), in Blocks 1 and 3.

4:08 am Celgene presents interim results from the ABOUND clinical trial of ABRAXANE; support safety, efficacy and tolerability (CELG) :

Co announced interim results from the ABOUND clinical trial program evaluating the use of ABRAXANE in patients with advanced non-small cell lung cancer

  • Interim ABOUND.70+ data in 128 elderly patients (= 70 years old) receiving first-line treatment with ABRAXANE/carboplatin for advanced NSCLC found that 91 (73%) patients experienced grade =2 peripheral neuropathy or grade =3 myelosuppression [primary endpoint].
  • At the time of the analyses, the median overall survival was 14.6 months and the median progression-free survival was 6.2 months, pooled across the two treatment arms [secondary endpoints].
  • Patients were randomized to receive first-line treatment with ABRAXANE/carboplatin either continuous weekly or weekly every three weeks with a one-week break.i Overall, 80% of patients discontinued treatment and the majority did so due to adverse events (24%) or disease progression (34%). Grade =2 PN was reported in 34% of patients, and grade =3 neutropenia, anemia, and thrombocytopenia was observed in 52%, 21% and 21% of patients, respectively. 
  • The interim ABOUND.sqm data in 284 patients receiving first-line induction treatment with ABRAXANE/carboplatin for stage IIIB/IV squamous NSCLC showed that the safety profile was consistent with that previously reported for the squamous subset in the pivotal Phase III trial.ii,iii During the induction phase, all patients received four 21-day cycles of standard ABRAXANE/carboplatin therapy.
  • Overall, 119 patients (42%) discontinued treatment during the induction phase.
  • The majority of patients discontinued treatment due to disease progression (34%) or adverse events (24%). The most common grade 3/4 treatment emergent adverse events were hematologic and included anemia (26%), neutropenia (43%) and thrombocytopenia (15%).

4:05 am Hutchison China MediTech reports pre-clinical data for HMPL-523; (HCM) :

CO announces that data from a recent pre-clinical study, investigating the in vitro and in vivo anti-tumor activities of novel Spleen Tyrosine Kinase inhibitor, HMPL-523.

  • In vitro in B-cell lymphoma cell lines with Syk/BCR dysregulation, HMPL-523 was found to block phosphorylation of B-cell linker protein as well as inhibit cell viability by inhibiting cell survival and increasing apoptotic rate. HMPL-523 also showed synergistic anti-tumor activity on human diffused large B-cell lymphoma cells, in combination with other drugs such as Phosphoinositide-3-Kinase d inhibitors, B-cell lymphoma 2 family inhibitors, or chemotherapies.
  • Potent anti-tumor activity was also demonstrated in nude mice bearing B-cell lymphoma xenograft tumors with Syk/BCR dysregulation.
  • Clinical development in oncology and immunology
    • In hematological malignancies, HMPL-523 is currently being studied in a Phase I dose escalation study, which was initiated in Australia in January 2016 and is expected to complete in the first half of 2017.
    • This study is in patients with relapsed and/or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia for whom there is no standard therapy.

4:02 am Teva Pharma receives positive outcome for COPAXONE; removal of pregnancy contraindication from label in Europe (TEVA) :

Co announced that it has received a positive outcome through the variation procedure to remove the pregnancy contraindication from the European label for COPAXONE 20 mg/mL. The product was originally authorized through a decentralized procedure in Europe.

  • The removal of the pregnancy contraindication follows a Positive Variation Assessment Report issued by the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and agreed by all Concerned Member States in Europe, that were involved in the procedure.
  • Granting of national approvals by all involved EU Member States will happen in the near future.
  • COPAXONE is indicated for the treatment of patients with relapsing forms of multiple sclerosis

4:00 am MorphoSys reports updated clinical results for MOR202; 91% of evaluable patients showed objective response (MPSYY) :

Co presented updated safety and efficacy data from an ongoing phase 1/2a clinical study evaluating MOR202 alone and in combination with immunomodulatory drugs lenalidomide and pomalidomide, plus dexamethasone, in heavily pre-treated patients with relapsed/refractory multiple myeloma

  • Patients treated with MOR202 in combination with Len/Dex had a median of 2 prior regimens; 64% were refractory to their last therapy. In this arm of the trial, 91% of evaluable patients (10 out of 11) showed an objective response (defined as either a complete response or a partial response) to MOR202 and Len/Dex.
    • Considering only patients in the highest dosing cohort of 16mg/kg MOR202 plus Len, ORR (objective response rate) was 100%, with 7 out of 7 patients showing response to treatment
  • In the group receiving MOR202 with Pom/Dex, patients had a median of 3 prior therapies, all being refractory to their last therapy. In these heavily pretreated patients, 57% (4 out of 7) showed a response, with two patients achieving a complete remission.
    • In relapsed/refractory patients treated with MOR202 alone, 29% (5 out of 17) showed an objective response.
  • Responses are ongoing in 16 of 19 patients, with the longest response ongoing for more than 14 months. The median progression-free survival of the patients treated with MOR202 alone was 4.7 months; the median PFS for the combination regimen has not yet been reached.

3:54 am Celyad SA presents new data from its CAR-T NKR-2 Phase I Trial; demonstrates strong safety signals, including no cases of cytokine release syndrome (CYAD) :

Co presented new data from the Phase I trial of NKR-2 in patients with acute myeloid leukemia and multiple myeloma

  • Strong safety signals, including no cases of cytokine release syndrome, cell-related neurotoxicity, auto-immunity, or CAR-T related death.
  • Although no blast reduction was observed, an AML patient reported no progression (3+months) and improvement in all hematological parameters under no additional therapy at the highest dose
  • Other previously reported patients also showed prolonged survival with unanticipated responses to subsequent treatments, and improvements in hematological parameters despite aggressiveness of baseline disease.
  • In vitro testing of the two patients for which tumor samples were available showed that CAR-T NKR-2 destroyed tumor cells, confirming the relevance of the previously published pre-clinical work.

3:52 am On The Wires (:WIRES) :

  • Trinity Place Holdings (TPHS) announced that in a joint venture with Pacolet Milliken Enterprises, Inc. they have closed on the acquisition of The Berkley, a newly built, market-leading 95-unit apartment building in Williamsburg, Brooklyn for $68.875 million. The purchase was capitalized by a $42.5 million interest-only senior loan from Freddie Mac at a spread of 216 basis points above LIBOR.
  • Ocwen Financial (OCN) announced the completion of the settlement of the previously announced Exchange Offer by its subsidiary Ocwen Loan Servicing, pursuant to which OLS issued $346.9 million aggregate principal amount of 8.375% Senior Secured Second Lien Notes due 2022 in exchange for $346.9 million aggregate principal amount of Ocwen's 6.625% Senior Notes due 2019 that had been tendered in the Exchange Offer.
  • Micron Technology (MU) announced that it has completed the acquisition of Inotera Memories, Micron acquired all of Inotera's outstanding shares for consideration worth 30 New Taiwan Dollars per share or approximately $0.94 per share. This represents a transaction value of ~$4.0 billion, net of cash and debt at Inotera, to acquire the equity not already owned by Micron.
  • Global Sources (GSOL) announced that the Company has renewed its contracts with AsiaWorld-Expo Management to host its trade shows at Hong Kong's AsiaWorld-Expo in 2019 and 2020 at a total contract value of ~$27.1 million.

3:50 am BeiGene presents updated clinical data for BGB-3111; demonstrates overall response rate of 94% (BGNE) :

Co presented updated clinical data from an ongoing Phase I study of BTK inhibitor BGB-3111 in patients with Waldenstrm's macroglobulinemia.

  • The updated clinical data continue to demonstrate that BGB-3111 is well-tolerated and highly active in WM, with an overall response rate of 94%, including a major response rate of 78% and a very good partial response rate of 34%, at a median follow-up time of 9.6 months.
  • As of October 3, 2016, the cutoff date for the current analysis, 33 patients were included in the safety analysis, and 32 of the 33 patients were evaluable for response as one patient had IgM
  • Adverse events were generally mild in severity, self-limited, and usually encountered only in the earlier part of the treatment course. The most frequent AEs (=20%) of any attribution were upper respiratory tract infection (39%), petechiae / purpura / contusion (33%), nausea (24%), diarrhea (24%), and constipation (21%), all of which were grade 1 or 2 in severity except for one case of diarrhea (3%).
  • Four serious AEs were assessed as possibly related to BGB-3111, including one case each of grade 3 cryptococcal meningitis, grade 3 pneumonia, grade 2 atrial fibrillation, and grade 2 vomiting. Other grade 3 or greater events considered possibly related to BGB-3111 included two cases of neutropenia and one case each of diarrhea, hypertension, increased liver function test, pulmonary hypertension, and vomiting. In total, three cases of atrial fibrillation were reported (all grade 1 or 2), and two of the three occurred in patients with pre-existing AF.
  • No serious hemorrhage (= grade 3 hemorrhage or CNS hemorrhage of any grade) was reported.
  • The only treatment discontinuation was due to exacerbation of pre-existing bronchiectasis in a patient who achieved a VGPR on BGB-3111, and the subsequent death of this patient was also the only fatal event in the study and was assessed by the investigator to be unrelated to study treatment

3:47 am Stone Energy provides operational update for its Amethyst well; no assurance well can be restored to previous levels (SGY) :

As previously reported, production from Stone's Amethyst well was shut in during late April 2016 to allow for a technical evaluation.

  • During the first week of November, we initiated acid stimulation work and intermittently flowed the Well during the month of November at a rate of 10 -- 15 million cubic feet of gas per day, while observing and evaluating the Well's performance. On November 30, 2016, we performed a routine shut in of the Well to record pressures and determined that pressure communication exists between the production tubing and production casing strings, resulting from a suspected tubing leak.
  • Co is currently diagnosing the pressure information in an attempt to determine the most likely failure points and expect to have a better understanding within one to two weeks.
  • Co has communicated our findings to date with the Bureau of Safety and Environmental Enforcement and will be working with BSEE in determining our next steps.
  • Co will evaluate our options to restore production from the Well, and all potential impacts on our estimated proved oil and gas reserves, which we anticipate will continue for at least several months.
  • The estimated proved reserves associated with the Amethyst well at year-end 2015 were ~79 billion cubic feet of gas equivalent.
  • Co can provide no assurance that it will be able to restore the Well's production to previous levels, or at all.
  • Co also cannot ensure that a replacement or sidetrack well would be economic, or that we would have sufficient liquidity if significant capital is needed to restore the Well's production.

3:44 am Agnico-Eagle Mines reports investment in G4G Capital Corp (AEM) :

Agnico Eagle Minesthat announced it has entered into a share purchase agreement with G4G Capital Corp, which is proposed to be renamed White Gold Corp,  pursuant to which Agnico Eagle has agreed to purchase from the Issuer on a private placement basis such number of common shares of the Issuer equal to 19.93% of the total issued and outstanding Common Shares on a non-diluted basis as at the closing of the Transaction

  • Agnico Eagle will pay $1.20 per Common Share.

3:41 am Starwood Property Trust prices 17.8 mln shares of common stock for gross proceeds of $394.3 mln (STWD) :  

3:40 am AbbVie presents new Phase 2 data for Ibrutinib; demonstrates 48% overall response rate (ABBV) :

Co announced efficacy and safety findings from a Phase 2 study demonstrating that nearly half (48%) of patients with relapsed/refractory marginal zone lymphoma had a complete or partial response with single-agent ibrutinib (:IMBRUVICA), as assessed by Independent Review Committee investigators. The median duration of response was not reached.

  • Overall, the safety data from this study was consistent with the known safety profile of ibrutinib in B-cell malignancies.
  • The most common adverse events (AEs) included fatigue (44%), diarrhea (43%), anemia (33%), nausea (25%), thrombocytopenia, peripheral edema and arthralgia (24% each), cough (22%), dyspnea and URTI (21% each). Grade 3 or 4 AEs occurred in 63% of patients.
  • The most frequent were anemia (14%), pneumonia (8%) and fatigue (6%). Grade 1 and 2 atrial fibrillation occurred in four (6%) patients
  • IMBRUVICA, a first-in-class Bruton's tyrosine kinase inhibitor, is jointly developed and commercialized by Janssen Biotech (JNJ) and Pharmacyclics LLC, an AbbVie company.

3:38 am Verastem reports Phase 2 DYNAMO clinical data; results in a 46% ORR in patients with double refractory indolent non-hodgkin lymphoma (VSTM) :

Co announced the presentation of results from the DYNAMO study, a Phase 2 clinical trial evaluating the safety and efficacy of duvelisib in patients with indolent non-Hodgkin lymphoma that is double refractory to both rituximab and chemotherapy.

  • The DYNAMO study included 129 evaluable patients with double refractory iNHL
  • The overall response rate (:ORR) was 46% as determined by independent review committee
  • Among disease subgroups, the ORR was 41% in follicular lymphoma, 68% in small lymphocytic lymphoma, and 33% in marginal zone lymphoma.
  • Median duration of response among all patients was 9.9 months.
  • Notably, 83% of patients had reductions in the size of their target lymph nodes per IRC.
  • Duvelisib was generally well tolerated, with an expected and manageable safety profile with appropriate risk mitigation. The most common Grade =3 adverse events included neutropenia (28%), infection (18%), diarrhea (15%), thrombocytopenia (13%) and anemia (12%).

3:35 am Cornerstone Pharmaceuticals (IDT Corp key investor) presents Phase I Data on CPI-613; demonstrates encouraging efficacy and safety results (IDT) :

Co presented data from two Phase I trials evaluating its lead compound, CPI-613. The two datasets show encouraging efficacy and safety results in patients with acute myeloid leukemia (:AML) and T-cell non-Hodgkin's lymphoma, respectively, supporting the clinical rationale for combining CPI-613 with standard chemotherapy in two hematologic malignancies that have historically been difficult to treat.

  • CPI-613 - A total of 67 patients (median age of 60 years, with ages ranging from 21-79 years) were enrolled, of whom 62 were ultimately evaluable.
    • The overall response rate (:ORR) was 50%, including 26 patients in complete remission (CR) and 5 in CR with incomplete blood count recovery (CRi); median survival was 6.7 months.
    • Response was significantly associated with survival, with a median survival of 13.2 months in responders versus 3 months for all others.
  • T-cell NHL Data
    • As of October 21, 2016, eight patients had been dosed; all eight were evaluable for safety and six were evaluable for efficacy. The most common grade 3 or higher toxicities, lymphopenia and neutropenia, occurred in four patients. The protocol was later amended to discontinue dose escalation at doses of 2,750 mg/m2 or higher for dose-limiting toxicities and to expand the 2,550 mg/m2 cohort.
    • The ORR was 83%. Three patients with peripheral T-cell lymphoma not otherwise specified (:NOS) attained a complete response. Two patients -- one with mycosis fungoides and one with angioimmunoblastic T-cell lymphoma -- had a partial response. One patient with T-cell acute lymphoblastic leukemia experienced progressive disease.

3:31 am Actinum Pharma reports results from Phase 1 Clinical Trial of Actimab-A; shows that 42% of patients with low peripheral blast burden responded to Actimab-A (ATNM) :

Co presents results from its Phase 1 trial of Actimab-A. Actimab-A is currently being studied in a 53-patient Phase 2 clinical trial as a monotherapy for patients newly diagnosed with Acute Myeloid Leukemia age 60 and above who are ineligible for currently used induction therapies. The Phase 2 trial is studying Actimab-A as a monotherapy administered via two fifteen minute intravenous injections of 2.0 Ci/kg/fraction of Actimab-A given a week apart.

  • Of the 18 patients in the Phase 1 trial, 28% (5 of 18) had objective responses (2 CR, 1CRp and 2 CRi). Amongst patients with objective responses, median response duration was 9.1 months (range, 4.1-16.9 months). At the 3 highest dose levels in the Phase 1 trial (1.0 Ci/kg/fraction - 2.0 Ci/kg/fraction) objective responses were seen in 33% of patients (5 of 15).
  • Mean bone marrow blast reduction amongst evaluable patients was 66% with 57% of patients having bone marrow blast reduction of 50% or greater and 79% of patients (11 of 14) had bone marrow blast reductions after Cycle 1 of therapy. The Phase 1 trial enrolled patients newly diagnosed with AML who are age 60 and above who were administered Actimab-A in combination with low-dose Cytarabine.
  • Median patient age was 77 with 67% of patients having prior myelodysplastic syndrome of which, 83% received prior therapy consisting of either hypomethylating agents or a hematopoietic stem cell transplant.
  • A formal interim analysis will occur after 31 patients receive Actimab-A, which the Company expects to occur in mid-2017. The Company anticipates the Phase 2 trial to be complete by the end of 2017.

3:25 am Uranium Resources retires $8 mln indebtedness occurring in in two tranches (URRE) :

  • Under the deal, an investor has purchased an initial $2.5 million amount of notes from RCF and has entered into an agreement to exchange these notes for shares of URI's common stock.
  • The investor has also agreed to purchase the remaining $5.5 million of notes from RCF and exchange such notes for shares of URI's common stock

3:23 am Zimmer Biomet discloses early tender of $2.6 bln of Notes; upsizes of its cash tender offers for certain outstanding debt securities (ZBH) :

  • The Co also announced that it is increasing the aggregate purchase price from $1.1 bln to $1.25 bln

3:21 am Sangamo BioSci reports data for its Hemophilia A Program; on track to file Investigational New Drug Application by end of 2016 (SGMO) :

Co announced the presentation of preclinical and manufacturing data that support SB-525, its gene therapy program for hemophilia A

  • The development of adenovirus associated vector cDNA gene therapy approaches for hemophilia A has been challenging due to a number of factors, including the large size of the native human Factor 8 gene, low levels of human Factor VIII protein expression from conventional promoters, and low yields of vector in large scale manufacturing processes. Through an iterative process Sangamo scientists have developed an improved AAV construct that expresses an hF8 cDNA cassette.
    • A single intravenous administration of SB-525 results in the expression of significant levels of hFVIII in mice and non-human primates (NHPs) and correction of the bleeding defect in a mouse model of hemophilia A. The construct also resulted in greatly improved AAV yields during vector manufacturing.
  • Importantly, dosing studies in NHPs which evaluated SB-525 manufactured at GMP-clinical scale demonstrated a robust and reproducible dose response curve and the most potent dose response in NHPs thus far disclosed for an hF8 cDNA gene therapy program.
    • In these animals, mean hFVIII levels ranged from 5% of normal at the lowest dose to 230% at the highest.
    • The therapeutic levels of hFVIII that were observed in these studies support starting clinical doses in the E11 vg/kg range. 

3:15 am LGI Homes reports November home closings rose 28.9% YoY (LGIH) :

Co announced 321 homes closed in November 2016, up from 249 home closings in November 2015, representing year-over-year growth of 28.9%.

  • The Company ended the first eleven months of 2016 with 3,696 home closings, a 24.4% increase over 2,971 home closings during the first eleven months of 2015.

3:14 am Agios Pharma reports new clinical data from Phase 1 Trial of Single Agent AG-120; Overall Response Rate of 38% and Complete Remission Rate of 18% (AGIO) :

Co presented new clinical data from the ongoing Phase 1 study evaluating single agent AG-120 in advanced hematologic malignancies

  • As of August 1, 2016, data from the completed dose-escalation portion of the Phase 1 trial from 78 patients with advanced IDH1 mutant positive hematologic malignancies treated with AG-120, including 63 patients with relapsed and/or refractory acute myeloid leukemia, continue to show a favorable safety profile and durable clinical activity.
  • Data from the ongoing expansion phases were not reported. For all dose escalation patients, an overall response rate of 38% (30 of 78) and a complete remission rate of 18% (14 of 78) were observed. For the 63 R/R AML patients, the overall response rate and complete remission rates were 33% (21 of 63) and 16% (10 of 63) respectively. Patients were on study treatment for up to 24.2 months with a median duration of response of 10.2 months for all responders and 6.5 months for the R/R AML responding patients.
  • In order to study the depth of response to single agent AG-120, molecular detection of the mutant IDH1 burden in blood and bone marrow samples were analyzed using next generation sequencing in 67 patients from the dose-escalation portion of the study. Molecular clearance was defined as reduction of the IDH1 mutation below the limit of detection of the assay (1% for IDH).
  • Molecular data show that treatment with AG-120 resulted in clearance of the IDH1 mutation in 36% of patients (5 of 14) in complete remission compared to 4% of patients (2 of 53) that did not achieve complete remission.
  • This is the first demonstration that treatment with single agent AG-120 can result in mIDH1 clearance

3:11 am Celgene reports combined analysis of CC-486; demonstrated had a 38% overall response rate (CELG) :

Co announced results from an analysis of three phase I/II studies evaluating CC-486 in patients with myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myeloid leukemia who had received prior hypomethylating agents

  • For all patients treated with CC-486, the overall response rate (:ORR), which included complete remission (CR), partial remission (:PR), CR with incomplete hematologic recovery (CRi; AML patients only), hematologic improvement (HI), and transfusion independence (TI), was 38%.
  • Marrow CR was assessed in MDS pts with =5% bone marrow blasts at baseline.
  • Four of 11 patients (36%) who were refractory to prior HMAs responded, including one AML patient who attained CR with CC-486. Five of 14 patients (35%) who had relapsed during or after prior HMA therapy responded. Of patients who had received at least six cycles of prior HMA therapy, the ORR was 33% (6/18).
  • The most frequent (=10%) grade 3-4 hematologic adverse events were anemia (34%) and thrombocytopenia (23%), neutropenia (17%).The most frequent grade 3-4 gastrointestinal adverse events were diarrhea and vomiting (11% each).

3:09 am Seattle Genetics and Bristol-Myers Squibb (BMY) highlight first data from Phase 1/2 study evaluating ADCETRIS; data showed 90% Objective Response Rate and 62% Complete Response Rate (SGEN) :

Seattle Genetics (SGEN) and Bristol-Myers Squibb (BMY) highlighted the first reported data from an ongoing phase 1/2 clinical trial evaluating ADCETRIS in combination with Opdivo in relapsed or refractory classical Hodgkin lymphoma

  • Preliminary Results from a Phase 1/2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma
    • Of 29 response-evaluable patients, 26 patients (90%) had an objective response, including 18 patients (62%) with a complete metabolic response and eight patients (28%) with a partial metabolic response. One patient (3%) had stable disease and two patients (7%) had progressive disease.
    • Of the 42 patients enrolled, all patients (100%) received one or more dose of the study therapies, 12 patients (29%) remain on treatment, 28 patients (67%) have completed treatment and two patients (five%) discontinued prior to the end of treatment. At the time of data analysis in the ongoing trial, nine patients (21%) initiated an ASCT and two patients (5%) received an alternative salvage therapy prior to ASCT. Preliminary analysis shows no impact of ADCETRIS and Opdivo combination on stem cell mobilization or engraftment.
    • The median number of doses administered for both ADCETRIS and Opdivo was four. Of the 42 patients, no patients had a dose reduction during treatment due to an adverse event for either therapy. Dose delays occurred for three patients (7%) with ADCETRIS treatment and four patients (10%) with Opdivo treatment. Reasons for dose delays were urticaria, thrombosis, elevated lipase, chills and hypoxia.
    • The most common adverse events of any grade occurring prior to ASCT in more than 20% of patients were fatigue, nausea, infusion related reaction, pruritus and rash. One patient had a treatment-related serious adverse event after Cycle 1 of ADCETRIS, with Grade 3 dehydration, Grade 1 asthenia and nausea, Grade 2 hypercalcemia and malaise.
    • Infusion-related reactions (IRR) were observed in 38% of patients and most symptoms included flushing and nausea (14% each); chest discomfort, dyspnea, urticaria (12% each); cough and pruritis (10% each). A protocol amendment was made requiring premedication with low-dose corticosteroids and antihistamine. No patients discontinued treatment due to an IRR.
    • Potential immune-related adverse events included IRR (36% [one IRR not reported as associated with infusion]; Grade 1 or 2), rash (29%; Grade 1 or 2), diarrhea (26%; Grade 1 or 2), transaminase elevation (10%; Grade 1 and 3/4) and hypothyroidism (five%; Grade 2). There were no occurrences of pneumonitis or colitis.

3:04 am Merck reports new KEYTRUDA data from pivotal KEYNOTE-087 trial show ORR of 69.0% and CRR of 22.4% (MRK) :

Co reported updated findings evaluating KEYTRUDA, the company's anti-PD-1 therapy, in two trials of patients with relapsed or refractory classical Hodgkin lymphoma.

  • In the KEYNOTE-087 and KEYNOTE-013 trials, KEYTRUDA demonstrated overall response rates (:ORR) of 69.0% and 58%, respectively. KEYNOTE-013, which had a median follow up of 29 months, showed responses of 12 months or greater in 70% of patients who responded to therapy.
  • Results from KEYNOTE-087:
    • Across all 210 enrolled patients, the ORR was 69.0% by BICR, and the complete remission rate was 22.4%. Across all cohorts, 93% of patients experienced a decrease in tumor burden.
  • Results from KEYNOTE-013:
    • Across all 31 patients enrolled in the KEYNOTE-013 classical Hodgkin lymphoma cohort, the ORR was 58% by BICR, and the complete remission rate was 19%.
    • Thirty-nine% of patients achieved partial remission and 23% had stable disease
    • The median duration of response was not yet reached and 70% of responding patients had a response of 12 months or greater.
    • The median duration of follow-up was 29 months

3:00 am Bluebirdbio provides updates on HSC gene therapy programs; confirms two-to-threefold increase in vector copy numbers observed in retrospective in vitro analyses (BLUE) :

Co provided updates across its hematopoietic stem cell (HSC) gene therapy programs, including:

  • Updated interim clinical data from the Northstar study of LentiGlobin drug product in transfusion-dependent -thalassemia confirm patients with non-0/0 genotypes and =12 months of follow-up have stopped regular transfusions; patients with 0/0 genotypes and =12 months of follow-up had a median reduction in transfusion volume of 63%
  • Drug product vector copy numbers for the first HGB-207 and HGB-206 patients who will be treated using LentiGlobin drug product made using our improved manufacturing process are 2.9 and 3.3, respectively
  • Updated interim clinical data from seven subjects in the HGB-206 study of LentiGlobin drug product in severe sickle cell disease  underscore the need for recently implemented protocol amendments seeking to improve HbAT87Q production in this population
  • Company to expand enrollment in Starbeam study of Lenti-DTM in cerebral adrenoleukodystrophy by eight patients

2:57 am Forum Energy Tech prices 7 mln shares of common stock by co and selling shareholders at a price to the public of $21.50 per share (FET) :

  • 3.5 mln shares are being offered by the Co and 3.5 mln shares are being offered by the Selling Stockholders

2:55 am Atkore International launches secondary public offering of 8 mln shares of common stock by selling stockholder (ATKR) :

  • The Company will not receive any proceeds from the sale of shares being sold in this offering.

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