InPlay from Briefing.com

7:50 am B.O.S. Better Online Solutions reports Q2 results (BOSC) :

  • Reports Q2 diluted net income per share of $0.05, compared to $0.02 in 2Q15; Q2 revs +3.4% to $6.31 mln compared to 2Q15.
  • "Our financial position continued to improve from quarter to quarter. As of June 30, 2016, our bank debt, net of cash, amounted to $1.8 mln"

7:45 am On The Wires (:WIRES) :

  • Lightbridge Corporation (LTBR) announces that it received official confirmation that the co is in compliance with all applicable requirements for listing on the Nasdaq Capital Market having met the bid price and shareholders' equity requirements.
  • FTI Consulting (FCN) announces the latest version of its RadianceTM visual analytics software platform. 
  • Chanticleer Holdings (HOTR) announces the geographical expansion of its agreement with a financial partner to include restaurants beyond the Seattle, Washington area. The investor is funding the opening of a Little Big Burger at Progress Ridge TownSquare in Beaverton, Oregon. Construction has begun and the restaurant is expected to open shortly.

7:31 am USG to sell L&W Supply to ABC Supply for $670 mln (USG) :

  • The transaction is expected to be completed before the end of 2016.
  • Completion of the Transaction will allow USG to reduce debt and achieve its target leverage ratio, accelerate high return investments in its Gypsum and Ceilings businesses through advanced manufacturing initiatives, and position the company to consider future capital returns to shareholders. The sale of L&W Supply is also expected to dampen USG's overall earnings cyclicality as well as provide opportunity for growth in the independent specialty dealer channel.
  • A conference call is being held at 9:00 a.m. Eastern time during which USG senior management will discuss the transaction.

7:31 am Providence Service Corporation announces it is selling 60% of Matrix Medical to Frazier Healthcare Partners, which values Matrix at ~$537.5mln (PRSC) :

  • Frazier Healthcare Partners to acquire a majority interest in Matrix Medical Network and Providence Service Corporation will maintain a significant interest and have representatives on Matrix's Board of Director. 
  • Transaction values Matrix at $537.5 mln
  • Providence to receive gross cash proceeds of approximately $418 mln before transaction costs, taxes, and customary post-closing adjustments. 
  • The strategic partnership with Frazier is expected to generate substantial strategic and operational benefits, such as:
    • Positioning Matrix to accelerate growth in its chronic care management and assessment offerings. 
    • Providing Matrix with access to Frazier's network and domain expertise in payor services, which can provide additional acquisition and investment opportunities for both Providence and Frazier. 
    • Allowing Providence to benefit from Matrix's enhanced earnings growth profile through its ongoing equity ownership.
  • Positioning Matrix to accelerate growth in its chronic care management and assessment offerings. 
  • Providing Matrix with access to Frazier's network and domain expertise in payor services, which can provide additional acquisition and investment opportunities for both Providence and Frazier. 
  • Allowing Providence to benefit from Matrix's enhanced earnings growth profile through its ongoing equity ownership.
  • Further details can be found in the 8-K to be filed on or about August 31, 2016.

7:29 am European Markets Update: FTSE CLOSED, DAX -0.7%, CAC -0.9% (:SUMRX) :

Major European indices trade lower across the board while UK's FTSE is closed for Summer Bank Holiday. Italy's MIB (-1.4%) has shown relative weakness with bank shares under pressure after the release of some disappointing data. All in all, the first half of the Monday session has been quiet.

  • In economic data:
    • Italy's August Business Confidence 101.1 (expected 102.5; last 102.9) and Consumer Confidence 109.2 (consensus 110.5; previous 111.2)
  • Italy's August Business Confidence 101.1 (expected 102.5; last 102.9) and Consumer Confidence 109.2 (consensus 110.5; previous 111.2)

---Equity Markets---

  • UK's FTSE is closed.
  • Germany's DAX is lower by 0.7% with exporters Volkswagen, Daimler, and BMW down between 1.1% and 1.7%. Deutsche Bank also lags, trading lower by 1.2%. On the upside, Deutsche Boerse has added 0.4%.
  • France's CAC has given up 0.9% amid broad weakness. ArcelorMittal is the worst performer, falling 3.0%, while Peugeot, Carrefour, Total, and Renault show losses between 1.1% and 2.0%. Financials Credit Agricole, BNP Paribas, and Societe Generale are all down near 1.0%.
  • Italy's MIB has slid 1.4%. Banca Pop Emilia Romagna, UBI Banca, Mediobanca, Banca Mediolanum, and Banca di Milano Scarl show losses between 1.7% and 2.6%.

7:12 am On The Wires (:WIRES) :

  • Abeona Therapeutics (ABEO) announces that enrollment has been completed for the low-dose cohort (n=3) in its ongoing Phase 1/2 trial for ABO-102 (AAV-SGSH).
  • PDL BioPharma (PDLI) announces that PDL has received ~$57.4 mln in connection with the termination of PDL's credit agreement with Paradigm Spine which included a repayment of the full principal amount outstanding of $54.7 mln as well as accrued interest and a prepayment fee.
  • Korea Electric Power (KEP) discloses in a regulatory filing that it entered into a Purchase and Sale Agreement with Cogentrix Solar Holdings, LLC on August 26, 2016 to acquire a photovoltaic power plant with an aggregate capacity of 30MW located in Alamosa County, Colorado, through a consortium with the COPA fund, a corporate partnership fund established by local institutional investors including the National Pension Service. KEPC plans to operate the power plant for 26 years from 2016 to 2042. Once regulatory approval and other conditions have been met, KEPC plans to make payment of the purchase price around end of October 2016.
  • AcelRx Pharmaceuticals (ACRX) announces that the co and its investigators will be presenting results from the Phase 3 SAP302 study of ARX-04 in 76 patients who were treated for moderate-to-severe acute pain in the emergency department. An oral presentation reviewing these results will be made at the International Society for Burn Injuries, which is taking place August 29 -- September 1 in Miami, Florida.
  • Caesars Entertainment (CZR) confirms in a regulatory filing that on August 26, 2016, the United States Bankruptcy Court for the Northern District of Illinois denied the motion by Caesars Entertainment Operating Company to extend an injunction enjoining the further prosecution of the lawsuits brought by BOKF, N.A., Wilmington Savings Fund Society, FSB, Relative Value-Long/Short Debt Portfolio, a Series of Underlying Funds Trust, Trilogy Portfolio Company, and Frederick Barton Danner, against Caesars Entertainment Corporation in New York and Delaware. Accordingly, the Guaranty Lawsuits will continue against CEC pursuant to their respective schedules. Arguments for summary judgment on the Guaranty Lawsuits brought in New York are scheduled for August 30, 2016. CEOC has filed a notice of appeal to the United States District Court for the Northern District of Illinois of the Bankruptcy Court's denial of the motion.

7:02 am Garmin's Garmin International responds to a modified order by the ITC on August 18, 2016, in the long-running investigation brought by Navico Holdings AS against Garmin (GRMN) :

  • The modified ITC order did not address Garmin's new tilted DownV scanning sonar transducer design -- which Garmin strongly asserts does not infringe -- that has been shipping since last December when the previous decision was made by the ITC.
  • The status of Garmin's new tilted transducer design relative to any of Navico's patents is still a matter pending before the courts and government agencies, and Navico has never accused Garmin's new tilted design of infringement before the ITC.
  • On August 25, 2016, Navico issued a press release regarding the ITC's modified order that incorrectly asserts that the new tilted design infringes on their patents as no court or government agency has ever made any infringement ruling on Garmin's new tilted transducer design.
  • All of these issues are currently pending before the Court of Appeals for the Federal Circuit, the court with review authority over the ITC, and Garmin anticipates a definitive ruling on these topics in early 2017.

7:02 am Inovio Pharma initiates a clinical study of its preventive Zika vaccine in 160 subjects in Puerto Rico (INO) :

Inovio's Cellectra-3P device is an intradermal DNA vaccine delivery device that has been shown to maximize antigen expression and immune responses in multiple human studies. Inovio will also assess differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory endpoint. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses - the immune responses necessary to fight viral infections - in small and large animal models.

  • Zika virus outbreak has been declared a public health emergency in Puerto Rico. The CDC estimates Zika will infect more than 25% of the Puerto Rican population by year end, providing the potential for this study's placebo control design to provide exploratory signals of vaccine efficacy.
  • In June, Inovio was the first to commence a human Zika trial, with sites in the U.S. and Canada. All 40 subjects for the first clinical study have been fully enrolled and dosed. Inovio expects to report results before the end of this year.

7:01 am Asian Markets Close: Nikkei +2.3%, Hang Seng -0.4%, Shanghai UNCH (:SUMRX) :

Equity indices across the Asia-Pacific region ended Monday on a mostly lower note while Japan's Nikkei (+2.3%) outperformed. The rally in Japan took place amid a 0.3% decline in the yen (102.15), which was pressured after Bank of Japan Governor Haruhiko Kuroda spoke on Saturday, reminding that the central bank is ready to implement more easing if needed.

  • In economic data:
    • Australia's July HIA New Home Sales -9.7% month-over-month (last 8.2%)
    • Hong Kong's July Retail Sales -7.7% year-over-year (last -8.9%)
  • Australia's July HIA New Home Sales -9.7% month-over-month (last 8.2%)
  • Hong Kong's July Retail Sales -7.7% year-over-year (last -8.9%)

---Equity Markets---

  • Japan's Nikkei gained 2.3% with nine sectors posting gains. Financials (+3.6%), industrials (+3.0%), and materials (+2.8%) outperformed while consumer staples (-0.6%) lagged. JTEKT, Alps Electric, Hino Motors, Showa Denko, Mazda Motor, and Yokohama Rubber gained between 5.5% and 7.1%.
  • Hong Kong's Hang Seng shed 0.4% amid weakness in gaming and property names. Galaxy Entertainment, Sands China, Sino Land, SHK Properties, and Henderson Land lost between 1.0% and 3.8%.
  • China's Shanghai Composite settled just below its flat line. Shandong Xinchao Energy, Shinva Medical Instrument, and Eastern Communications lost between 3.3% and 4.0% while Zhongzhu Holding, Hengli Petrochemical, and Shanghai Tianchen advanced between 4.9% and 5.5%.
  • India's Sensex added 0.4%. Tata Motors spiked 4.2% in reaction to better than expected results while Reliance Industries, Hero MotoCorp, Vedanta, and Hindalco Industries gained between 2.1% and 2.9%.

---FX---

  • USDJPY +0.3% to 102.15
  • USDCNY +0.2% to 6.6812
  • USDINR +0.1% to 67.193

7:01 am Cubic announces five-year ~$80 mln task order to support aviation training for the U.S. Navy and Marine Corps under the Navy's Fielded Training Systems Support (CUB) :

  • Co announces the award of a five-year, ~$80 mln task order to support aviation training for the U.S. Navy and Marine Corps under the Navy's Fielded Training Systems Support IV Indefinite Delivery Indefinite Quantity Multiple Award Contract.
  • This is the first award by the Naval Air Warfare Center, Training Systems Division using this fourth-generation IDIQ program -- that has an estimated ceiling value of $1.75 billion.

7:00 am Tonix Pharma announces end-of-Phase 2 Meeting with FDA for TNX-102 SL in post-traumatic stress disorder (TNXP) :

  • Co announces that it has received the final meeting minutes from the FDA from an End-of-Phase 2/Pre-Phase 3 meeting. These minutes confirmed the FDA's acceptance of Tonix's proposed Phase 3 studies and the planned New Drug Application data package to support the registration of TNX-102 SL for the treatment of PTSD.
  • Tonix plans to commence a randomized, double-blind Phase 3 clinical study of TNX-102 SL, 5.6 mg, in military-related PTSD in the first quarter of 2017 and to commence a randomized, double-blind Phase 3 clinical study of TNX-102 SL in predominantly civilian PTSD later in 2017.
  • Tonix expects the planned open-label extension studies to provide sufficient long-term safety exposure data to support the TNX-102 SL NDA for the treatment of PTSD.

6:44 am Pointer Telocation signs binding agreement to acquire Cielo Telecom for approximately $6.5 mln; accretion expected (PNTR) :

Cielo Telecom is a fleet management services company based in South Brazil. Cielo Telecom manages fleet customers covering approximately 16,000 trucks.

  • "Given our existing infrastructure in Brazil, we see strong synergistic potential from the combination of the newly acquired business with ours, and we expect the acquisition to be accretive as of the first day. We expect this acquisition to position us as one of the leading Fleet Management companies in Brazil."

6:44 am On The Wires (:WIRES) :

  • CEMEX, S.A.B. de C.V. (CX) announces that it will be participating in the proposed corporate restructuring of Grupo Cementos de Chihuahua, S.A.B. de C.V. ("GCC") that was announced by GCC and which has the purpose of simplifying GCC's current shareholder structure. If approved by GCC's shareholders as proposed, CEMEX will directly own 23% of the outstanding share capital of GCC and, additionally, own a minority interest in CAMCEM, an entity which in turn will own a majority interest in GCC as a result of the proposed restructuring.
  • CEMEX, S.A.B. de C.V. (CX) announces that it has reached an agreement with Grupo Cementos de Chihuahua, S.A.B. de C.V. ("GCC") on the terms and conditions regarding the sale to GCC of certain assets in the U.S. originally announced on May 2, 2016. Upon closing of this transaction GCC will pay CEMEX $306 mln.
  • 21Vianet Group (VNET) announces the acceptance, results and settlement of the co's invitation to all holders of the 6.875% Bonds due 2017 to tender their Bonds for purchase for cash upon the terms and subject to the conditions set forth in an offer to purchase dated August 1, 2016. As of the Expiration Time, tender instructions with respect to RMB1,579,400,000 aggregate principal amount of the Bonds, representing 78.97% of the outstanding principal amount of the Bonds, have been received and such Bonds have been validly tendered pursuant to the terms and conditions of the Offer to Purchase.
  • Giga-tronics (GIGA) discloses in a regulatory filing that on August 19, 2016, Spanawave Corporation filed an action against the Company in Contra Costs Superior Court for alleged breach of contract and alleged breach of the implied covenant of good faith and fair dealing. The complaint seeks specific performance of the agreement and damages. The parties may continue to negotiate in an effort to settle the dispute notwithstanding the filing.
  • Woolworths Group (WOLWF) confirms that it became aware of an ex parte application filed by Lowe's (LOW) in relation to the home improvement joint venture company, Hydrox Holdings Woolworths is yet to be served with documents relating to this application. The transactions relating to the Home Timber and Hardware sale and Masters inventory clearance by GA Australia are proceeding as announced.
  • NextEra Energy (NEE) announces that it has secured access to a contingent of financial institutions to act as financial advisors related to its previously announced definitive agreement to acquire 100% of the equity of reorganized Energy Future and certain of its direct and indirect subsidiaries, including EFH's ~80% indirect interest in Oncor Electric Delivery Co. NextEra Energy expects the transaction to be completed in the first quarter of 2017.
  • Comstock (CRK) has extended the previously announced early tender date and expiration date of 11:59 pm ET on Aug 26, 2016 to exchange any and all of its existing senior notes for three new series of secured notes and, in the case of the 10% senior secured notes due 2020, warrants exercisable for common stock to the new early tender date and expiration date of 11:59 pm ET on Sept 2, 2016.

6:30 am Orion Group Holdings announces a contract award of ~$28 mln (ORN) : The project will begin at the end of the 3rd quarter of 2016 with a duration of ~18 months.

6:30 am China Lending announces that its Board approved a one-time dividend of $0.09 per ordinary share (CLDC) :  

6:12 am On The Wires (:WIRES) :

  • Matador Resources Company (MTDR) announces the start-up last week of the Black River cryogenic natural gas processing plant Matador built in its Rustler Breaks prospect area in the Delaware Basin of Eddy County, New Mexico. The processing plant has an inlet capacity of ~60 mln cubic feet of natural gas/day.
  • Eco-Stim Energy Solutions (ESES) announces it has deployed two well stimulation crews at the same time.
  • Sizmek (SZMK) and Vector Capital announce that Solomon Merger Subsidiary has commenced the previously-announced tender offer for all of the outstanding shares of common stock of the co at a price of $3.90 per share, net to the seller in cash without interest.
  • Nam Tai Property (NTP) announces that on August 18, 2016, the Company signed a non-binding strategic cooperation agreement with China Construction Bank Corporation, Shenzhen Branch. Pursuant to the Strategic Cooperation Agreement, China Construction Bank intends to finance the co with a US$750 mln ($5 bln Renminbi) revolving credit loan in the next five years to support the co's construction costs in its land development projects.

6:05 am S&P futures vs fair value: +0.50. Nasdaq futures vs fair value: -1.00. :

6:05 am European Markets : FTSE...Holiday.........  DAX...10,504.26...-83.30...-0.80%.

6:05 am Asian Markets : Nikkei...16,737.49...+376.80...+2.30%.  Hang Seng...22,831.54...-78.00...-0.30%.

6:04 am Deutsche Bank confirmed agreement to sell subsidiary in Argentina to Banco Comafi S.A. (DB) :

  • Co announced that as part of the Bank's Strategy 2020 plan to rationalize its global footprint, it has entered into an agreement to sell its subsidiary in Argentina to Banco Comafi S.A. Deutsche Bank will continue to serve its clients in Argentina from global and regional hubs. 
  • The transaction is expected to close in the first half of 2017, subject to regulatory approvals and other customary conditions. Terms of the transaction were not disclosed.

6:02 am CTI BioPharma announces top-line results from PERSIST-2 phase 3 trial of pacritinib for high-risk patients with advanced myelofibrosis (CTIC) :

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses.

  • Preliminary results demonstrated that the Persist-2 trial met one of the co-primary endpoints showing a statistically significant response rate in spleen volume reduction in patients with myelofibrosis treated with pacritinib compared to BAT, including the approved JAK2 inhibitor ruxolitinib. Although the Persist-2 trial did not meet the other co-primary endpoint of greater than 50 percent reduction in Total Symptom Score, the preliminary analysis approached marginal significance compared to BAT.
  • The co-primary endpoints of the trial were the proportion of patients achieving a 35 percent or greater reduction in spleen volume from baseline to Week 24, as measured by magnetic resonance imaging or computerized tomography and the proportion of patients achieving a total symptom score reduction of 50 percent or greater using MPN-SAF TSS 2.0 diary from baseline to Week 24.
  • The most common treatment emergent adverse events for pacritinib were generally manageable diarrhea, nausea and vomiting. The incidence of cardiac and bleeding adverse events were similar across the arms. Overall mortality rates were comparable between arms.
  • Additional data from ongoing analyses along with top-line results from Persist-2 will be submitted for presentation at an upcoming scientific meeting.

6:01 am Cynapsus Therapeutics announces that the FDA has granted Fast Track Designation for APL-130277 (CYNA) :

  • APL-130277 is a product candidate for the treatment of OFF episodes in patients with Parkinson's disease. 
  • Based on patient visit schedules, post the dose titration phase, top line data for the Phase 3 Efficacy trial CTH-300 is expected in mid-to-late fourth quarter of 2016.
  • the CTH-201 Phase 2 Thorough QT study, is expected to commence in the fourth quarter of 2016, and is planned to be completed in the first half of 2017.

6:01 am Mylan Labs announces that its U.S. subsidiary will launch the first generic to EpiPen Auto-Injector at a list price of $300 per generic EpiPen two-pack carton (MYL) :

EpiPen and EpiPen Jr Auto-Injectors are used for the emergency treatment of life-threatening allergic reactions.

  • The co expects to launch the product in several weeks, pending completion of labeling revisions. Upon launch, the product will be available as a two-pack carton in both 0.15 mg and 0.30 mg strengths. Mylan also intends to continue to market and distribute branded EpiPen.
  • Mylan intends to initiate a direct ship program in conjunction with the launch of the generic at the $300 generic list price. Mylan also continues to fight for enhanced access to epinephrine auto-injectors through other measures, such as inclusion of the product on the federal and private insurance preventive drug lists, which could potentially eliminate all co-pays.

5:44 am Dr. Reddy's announces the launch of Nitroglycerin Sublingual tablets in the U.S. Market Hyderabad, India (RDY) :

Co announced that it has launched Nitroglycerin sublingual tablets USP, 0.3 mg, 0.4 mg and 0.6 mg, a therapeutic equivalent generic version of Nitrostat sublingual tablets in the US market on August 26, 2016, having been approved by the FDA.

  • The Nitrostat sublingual tablet brand had U.S. sales of ~$ 108 Million MAT for the most recent twelve months ending in March 2016 according to IMS Health
  • Nitrostat is currently marketed by Pfizer (PFE)

5:23 am On The Wires (:WIRES) :

  • Novogen (NVGN) announced that Dr Gordon Hirsch appointed as Chief Medical Officer, with responsibility for clinical development of Novogen's pipeline - formerly Vice President and Regional Medical Officer at Sanofi (SNY). 
  • Toshiba Corporation's (TOSBF) Storage & Electronic Devices Solutions Company announced the launch of industry-leading photocouplers for high-speed communications at data rates up to 50Mbps. Shipments of the two new products "TLP2767" and "TLP2367" start from today.

4:36 am Bayer reports new data for Xarelto, reaffirming positive benefit-risk profile in everyday clinical practice (BAYRY) :

Co announced that new real-world data from multiple countries on its oral Factor Xa inhibitor Xarelto in patients with non-valvular atrial fibrillation were presented at ESC Congress 2016.

  • Data from XAPASS - a prospective observational post-authorisation study, which enrolled more than 11,000 patients in Japan - confirmed low rates of both stroke and major bleeding in patients with non-valvular AF newly-initiated on rivaroxaban in routine clinical practice. These results were generally consistent with the Phase III J-ROCKET AF randomised clinical trial. Additionally, real-world insights from National Registers of a total of 57,498 patients in Sweden showed similar rates of major bleeding among patients treated with rivaroxaban and warfarin, but significantly lower rates of intracranial bleeding among patients treated with rivaroxaban.
  • Additionally, real-world insights from National Swedish Registers compared the incidence rate of major bleeding with rivaroxaban and warfarin in patients with non-valvular AF. Results showed similar rates of major bleeding with rivaroxaban and warfarin. However, rates of intracranial bleeding were significantly lower with rivaroxaban compared with warfarin.
  • Furthermore, updated results from the REVISIT-US study, a retrospective claims database analysis performed using U.S. MarketScan claims data, were also presented at ESC Congress 2016.
    • Results from REVISIT-US were initially presented at this year's congress of the European Cardiac Arrhythmia Society and in this real-world setting showed that rivaroxaban was seen to be associated with a non-significant 29% decrease in ischemic stroke accompanied by a significant 47% reduction in intracranial haemorrhage (:ICH) vs. warfarin.
    • Looking at the combined endpoint of ICH or ischemic stroke, rivaroxaban resulted in a significant 39% reduction vs. warfarin in REVISIT-US
  • Results from REVISIT-US were initially presented at this year's congress of the European Cardiac Arrhythmia Society and in this real-world setting showed that rivaroxaban was seen to be associated with a non-significant 29% decrease in ischemic stroke accompanied by a significant 47% reduction in intracranial haemorrhage (:ICH) vs. warfarin.
  • Looking at the combined endpoint of ICH or ischemic stroke, rivaroxaban resulted in a significant 39% reduction vs. warfarin in REVISIT-US

4:23 am Stada Arzneimittel votes to remove Chairman Dr Martin Abend; elects Carl Ferdinand Oetker as new Chairman of the Board (STDAF) :

Co announced the Supervisory Board of STADA Arzneimittel AG has elected Carl Ferdinand Oetker as new Chairman of the Board.

  • Prior to this the Annual General Meeting has removed former Chairman Dr. Martin Abend.
  • The shareholder meeting of STADA Arzneimittel AG has today resolved with 55.98% of the votes cast to remove the chairman of the supervisory board Dr. Martin Abend as a member of the company's supervisory board with effect as of the conclusion of the shareholder meeting on 26 August 2016.

3:50 am On The Wires (:WIRES) :

  • TIM and Samsung (SSNLF), in collaboration with Gemalto (GTOMY), launched the first smartwatch in Italy with an integrated embedded SIM, representing the evolution of the SIM Card and mobile devices. Samsung's Gear S2 Classic 3G Smartwatch is the first wearable device in the world with eSIM, a technological innovation that marks a further step towards the digital future of the Internet of Things.
  • CGG (CGG) announced at ONS 2016 the launch of TopSeis, the latest evolution in offshore broadband seismic, specifically designed to overcome the intrinsic lack of near offsets inherent in 3D towed-streamer seismic.
  • Vale S.A. (VALE) informed that the results of the investigation requested to Cleary Gottlieb Steen & Hamilton LLP on the rupture of the Fundo Dam in Mariana will be disclosed on August 29th at 2:00 pm EDT and it will be broadcasted live via webcast in English and Portuguese. The link will be available on Vale's webpage.
  • Following the dam rupture, Samarco, along with Vale and BHP Billiton (BHP), Samarco's shareholders, hired Cleary Gottlieb Steen & Hamilton LLP to carry an external investigation into the cause of the dam rupture.
  • Statoil (STO) announced it is increasing the value of Johan Sverdrup. The first phase is currently estimated at NOK99 billion, (Capex numbers in nominal terms based on project currency) a reduction of NOK24 billion since the PDO was submitted. The present break-even is reduced to below $25 per barrel for phase 1.

2:55 am Regeneron Pharma and Sanofi (SNY) present Phase 3 data for Praluent meets primary endpoint (REGN) :

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced detailed positive results from ODYSSEY ESCAPE, a Phase 3 trial which evaluated Praluent Injection in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia who require regular weekly or bi-weekly apheresis treatment.

  • The trial demonstrated that adding Praluent to existing therapy reduced LDL cholesterol by approximately 50% from baseline (compared to 2% increase for placebo).
  • Praluent significantly reduced the need for apheresis treatment by 75% compared to placebo (p less than 0.0001), the primary endpoint of the study. Results will be presented today at a Hot Line session at the ESC Congress 2016 in Rome, Italy.
  • Apheresis is a procedure similar to kidney dialysis where bad (LDL) cholesterol is removed from the blood, and is usually reserved for high-risk patients with very high cholesterol unable to achieve their cholesterol-lowering goals on any other therapy.
  • Despite being treated with apheresis and entering ODYSSEY ESCAPE with very high LDL cholesterol levels (4.7 millimoles/liter [mmol/L] or 181 milligrams/deciliter [mg/dL]), nearly two-thirds (63%) of patients treated with Praluent no longer required apheresis therapy after six weeks of receiving Praluent.
  • At this same time point, the average LDL cholesterol level among the Praluent-treated group was 2.3 mmol/L (90 mg/dL), compared to 4.8 mmol/L (185 mg/dL) in the placebo group.

2:52 am Amgen presents new data for Repatha indicating efficacy and safety across risk groups (AMGN) :

Co announced data presented showing Repatha consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (:CV) risk subgroups or with familial hypercholesterolemia.

  • The analysis showed that treatment with Repatha 140 mg every two weeks or 420 mg monthly consistently reduced levels of LDL-C and other lipids from baseline to the mean of weeks 10 and 12 across all risk categories compared to placebo or ezetimibe controls. For example, among very high-risk patients, Repatha reduced LDL-C levels from baseline 65.2% more than placebo and 40.7% more than ezetimibe. The rates of overall adverse events were similar for the three groups, occurring in 43.1%, 50.5% and 40.8% of patients on Repatha, ezetimibe and placebo, respectively.
  • In another presentation, researchers looking at the "Long-term safety, tolerability and efficacy of evolocumab in patients with heterozygous familial hypercholesterolaemia," found that treatment with Repatha for 48 weeks resulted in persistent and marked LDL-C reductions in these patients. The analysis showed that Repatha plus standard of care reduced LDL-C levels from baseline by 53.6% at 48 weeks, compared to a 2.1% increase for SoC alone.
    • The pooled analysis included 440 patients with heterozygous familial hypercholesterolemia who completed Amgen's RUTHERFORD-1 or RUTHERFORD-2 trials and entered open-label extension trials.
    • Patients were randomized in the extension trials to receive SoC alone or Repatha plus SoC. Repatha was well tolerated in the extension studies with no new safety signals. The rates of overall adverse events were similar for the two groups, occurring in 80% of patients receiving Repatha and 67% of patients receiving SoC.
  • The pooled analysis included 440 patients with heterozygous familial hypercholesterolemia who completed Amgen's RUTHERFORD-1 or RUTHERFORD-2 trials and entered open-label extension trials.
  • Patients were randomized in the extension trials to receive SoC alone or Repatha plus SoC. Repatha was well tolerated in the extension studies with no new safety signals. The rates of overall adverse events were similar for the two groups, occurring in 80% of patients receiving Repatha and 67% of patients receiving SoC.

2:45 am Roche Hldg's Zika PCR test receives Emergency Use Authorization from the FDA (RHHBY) :

Co announced that the FDA has issued an Emergency Use Authorization for the LightMix Zika rRT-PCR Test.

  • The product is for use in patients meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. The test is used for the detection of Zika virus in EDTA plasma or serum samples using Roche's LightCycler 480 Instrument II or cobas z 480 Analyzer.
  • In addition to the LightMix Zika rRT-PCR Test, Roche has also developed the cobas Zika Test for use with the cobas 6800/8800 Systems.
  • This test is available under an Investigational New Drug Application protocol to initiate collection and testing of blood samples for screening. It is currently being utilized in blood centres in the United States.

2:35 am On The Wires (:WIRES) :

  • Royal Philips (PHG) announced the launch of IntelliSpace Cardiovascular 2.1, the latest version of its next-generation Cardiovascular Image and Information Management System. Showcased at the Philips Booth during the ESC Congress 2016, IntelliSpace Cardiovascular provides clinicians with a single point of access anytime and virtually anywhere and allows for web-based echo reporting, delivering diagnostic quality viewing of echo images.
  • Axiall Corporation (AXLL) statement: At approximately 8:40 a.m. on Saturday, Aug. 27, 2016, a rail tanker car loaded with liquid chlorine developed a leak inside the Axiall Natrium chemical facility, which is located in Marshall County near Proctor, W.Va. The rail car is no longer leaking. Hazmat crews are on site and are evaluating the railcar and area of the leak. The Natrium plant was evacuated and is currently shut down.
  • Delta Galil Industries announced that it has completed its previously announced acquisition of contemporary premium brands, including the businesses and brands of 7 For All Mankind, Splendid and Ella Moss from VF Corporation (VFC).
  • Samsung Electronics (SSNLF) extends its innovation in displays with the release of its most powerful and visually compelling curved gaming monitors to date. The CFG70 (available in 24 and 27 inch) and CF791 (34-inch) monitors provide distinguished curvatures of 1800R and 1500R, respectively. Other best-in-class features include interactive LED lighting, an intuitive user dashboard, and AMD FreeSync Technology for the ultimate gaming experience.

2:29 am LivaNova reports results from its RESPOND-CRT trial confirming significant long term risk reduction in heart failure hospitalization (LIVN) :

Co announced long term results from the RESPOND-CRT clinical trial after an 18 month follow-up period. The RESPOND-CRT trial was designed to investigate the clinical efficacy and safety of device-based optimization using LivaNova's proprietary SonR cardiac contractility sensor technology in patients with advanced heart failure.

  • Previously, on May 5, 2016, LivaNova announced the RESPOND-CRT one-year results at the annual Heart Rhythm Society (HRS) and subsequently published a press release.
  • The one-year data showed that the study met its primary safety and efficacy end points and demonstrated that SonR was associated with a 35% risk reduction in heart failure hospitalization.
  • Automatic optimization with SonR was compared to manual echocardiography guided optimization. The proprietary SonR optimization system allows for cardiac resynchronization therapy to be continuously adapted to the needs of each patient, thus delivering an individualized therapy.
  • Longer term results, after a complete 18 months patient follow-up, confirmed the significant risk reduction in heart failure hospitalization on the overall population enrolled in the study.
  • Additionally, in subgroups of patients with atrial fibrillation and renal dysfunctions, a 48% and 41% risk reduction in cardiovascular death or hospitalization was observed with SonR, respectively.

2:27 am Medtronic reports long-term results of Micra Transcatheter Pacing System demonstrating consistent, sustained safety and effectiveness (MDT) :

Co announced new long-term results from the Medtronic Micra Transcatheter Pacing System Global Clinical Trial in a clinical trial update late-breaking session at the 2016 European Society of Cardiology Congress in Rome.

  • The Micra TPS is less than one-tenth the size of traditional pacemakers and is the only leadless pacemaker approved for use in both the U.S. and Europe. Data presented today at ESC showed that the risk for major complications with the Micra TPS remained consistently low, with 96 percent of patients experiencing no major complications through 12 months follow-up.
  • The Micra TPS reduced the risk of major complications by nearly half (48%) compared to conventional systems and the risk was lower across all patient sub-groups, whether measured by age, sex or comorbidity.
  • The overall reduction in major complications with the Micra TPS was associated with a 47% decrease in the risk of hospitalization and 82 percent reduction in risk of system revisions (meaning extraction, repositioning or replacement) compared to conventional pacing systems.
  • These reductions were largely due to the elimination of complications such as pneumothoraces (air between the lungs and chest wall), the absence of Micra dislodgements and device infections.

2:18 am China Petroleum (Sinopec) beats by CNY0.04 (SNP) :

Reports H1 EPS of CNY0.17 vs CNY0.13 Capital IQ consensus

  • Exploration and Production: the Company effectively optimised exploration and development activities. Its continuing efforts in exploration paid off with major discoveries in a number of regions. It attached great importance to the development of natural gas and actively expanded shale gas business. As for production operation, the Company strengthened cost discipline, substantially reduced low-efficiency and high-cost oil production, and increased natural gas production. This segment realized an operating loss of RMB 21.9 billion in the first half of 2016 but continued to generate cash inflow from operating activities.
  • Refining: the Company adjusted its product mix in response to sharp increase of throughput from other refineries and abundant market supply. The Company further optimised its oil product mix by increasing the production of gasoline, kerosene and light chemical feedstock with a further decline in diesel-to-gasoline ratio. In the first half of 2016, this segment realised an operating profit of RMB 32.6 billion, representing an increase of 113% year on year. The refining margin was RMB 514.4 per tonne, representing an increase of 47.9% year on year.
  • Marketing and Distribution: the Company coordinated and optimised internal and external resources and took full advantage of the synergies between its fuel and non-fuel businesses, achieving growth in their total business volume and retail transactions despite ample fuel supply and strong competition in the market. In addition, the Company adjusted marketing efforts by increasing the retail operation of premium products with high-octane numbers. Non-fuel business sustained rapid development with transaction amount significantly increased by 43% year on year. This segment's operating profit was RMB 15.8 billion, representing an increase of RMB 600 million year on year. 
  • Chemicals: the Company continued to adjust the structure of its feedstock, products and facilities. The Company further lowered the feedstock cost for ethylene, strengthened the integration among production, sales, product R&D and customer needs. The proportion of performance polymer and differentiated products further increased. The Company maintained low inventory operation and implemented differentiated marketing strategy. Total transaction of chemical products increased by 8.3% year on year. This segment's operating profit in the first half of 2016 stabilized at RMB 9.7 billion.

Capital Expenditures

  • Total capital expenditures were 13.474 billion yuan.
  • Capital expenditures for the exploration and production segment were 5.168 billion yuan, mainly for Phase Two of shale gas development in Fuling, the LNG terminals in Guangxi and Tianjin, and Phase Two of the Jinan-Qingdao gas pipeline

2:08 am Kenon Holdings provides updates on its CDA and Samay I plants; CDA reaches commerical operation (KEN) :

Co provided the following updates with respect to its subsidiary I.C. Power Pte's Cerro del Aguila ("CDA") and Samay I plants:

Update on CDA

  • On August 25, 2016, the third generating unit of CDA, a 510 MW run-of-the-river hydroelectric plant in Peru, reached commercial operation. The first two units reached commercial operation on August 3, 2016. With the completion of this unit, CDA is now capable of generating 510MW, making IC Power the principal power producer in Peru.
  • CDA is party to three power purchase agreements beginning in 2016, 2018 and 2022 for a significant portion of its capacity, contracting most of its firm energy between 2018 and 2027. As of March 31, 2016, the weighted average remaining life of CDA's PPAs based on firm capacity was 12 years.

Update on Samay I

  • The four operating units of Samay I were declared operational on May 26, 2016. Recent inspections revealed structural damage to units 2, 3, and 4, and as a result, all four units were declared unavailable to the system.
  • The Company, together with the EPC contractor for the plant and the equipment manufacturer, are in a process of trying to determine the cause of the damage.
  • The cost and the time for the necessary repairs and part replacements have not yet been fully determined.
  • Based upon preliminary estimates, repair schedules indicate that all four units should be operational within the next 6 months, but IC Power continues to assess the situation and no definitive determination has been made as to when the units will return to operation

1:56 am On The Wires (:WIRES) :

  • AT&T (T) and Home Box Office, Inc. have reached a multi-year, strategic agreement that will extend HBO's (TWX) award-winning content across all AT&T products. The agreement renews HBO's existing contract with the AT&T DIRECTV and U-verse services, and will also make all HBO and CINEMAX content available on DIRECTV NOW. AT&T expects the new streaming service to roll out by the end of the year.
  • Ecopetrol S.A. (EC) has been notified of Resolution 53015 of 2016, issued by the Superintendence of Industry and Commerce, pursuant to which an investigation is being opened regarding the alleged committing of restrictive business practices in the natural construction materials market, for materials extracted from the river basins of the Acacias, Castilla La Nueva and Guamal municipalities.