5:54AM Volkswagen AG recorded a good delivery performance in November with volumes up 3.4% to 522,100 (November 2012: 504,800) units (VLKAY) 51.25 : In the Asia-Pacific region, the Volkswagen Passenger Cars brand grew deliveries by 15.8 percent from January to November, handing over 2.46 (2.12) million vehicles to customers, of which 2.26 (1.92; +17.5 percent) million units were delivered in China (including Hong Kong), the region's largest single market. In contrast, deliveries in India declined to 54,300 (63,600; -14.7 percent) units. In the North America region, the delivery level was unchanged, with the brand handing over 563,000 vehicles, of which 373,700 (394,100; -5.2 percent) new models were handed over to customers in the United States.
5:35AM Lake Share Gold increases 2014 production guidance (LSG) 0.38 : Co provides updated guidance for 2014, including target gold production of 160,000 to 180,000 ounces. Previously, the Company had indicated a target range for annual production of 140,000 to 160,000 ounces. Other guidance for 2014 includes cash operating cost per ounce sold between $675 and $775 and all-in sustaining cost per ounce sold between $950 and $1,050.
5:33AM Toll Brothers beats by $0.10, reports revs in-line (TOL) 33.58 : Reports Q4 (Oct) earnings of $0.54 per share, $0.10 better than the Capital IQ Consensus Estimate of $0.44; revenues rose 65.1% year/year to $1.04 bln vs the $1.04 bln consensus.
3:54AM On The Wires (WIRES) :
3:50AM Huntsman to issue EUR200 mln in Senior Notes due 2021 (HUN) 23.62 :
3:44AM Cell Therapeutics presents interim results from Phase 2 Tosedostat Trial in older patients with acute myeloid leukemia or myelodysplastic syndrome (CTIC) 1.82 : Co presents promising interim results from an investigator-initiated Phase 2 clinical trial of tosedostat in combination with cytarabine or decitabine in newly diagnosed older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome. Tosedostat is a first-in-class selective inhibitor of aminopeptidases, which are required by tumor cells to provide amino acids necessary for growth and tumor cell survival. Tosedostat is administered orally and has been previously shown to induce complete remissions as monotherapy in relapsed or refractory AML.
This presentation reported on the results of 26 patients (median age was 69) enrolled in the first dose cohort. Patients were randomized to treatment with tosedostat in combination with either cytarabine or decitabine. Fourteen out of 26 (54%) patients in this cohort had either a complete response (39%) or complete response with incomplete blood count recovery (CRi; n=4, 15%). The%age of complete responses was comparable between arms. Seven (50%) of the 14 CR/CRi were achieved in patients with poor-risk cytogenetic features. Importantly, 10 of the 26 patients subsequently went on to receive hematopoietic stem cell transplant. The study achieved its primary objective with 21 (82%) patients alive at four months. Median overall survival was encouraging at ~12 months for both study arms. Tosedostat combination therapy was well tolerated and predominantly administered as an outpatient therapy. The primary side effects of the combination therapy, the majority of which were associated with the cytarabine arm, included febrile neutropenia (50%), pulmonary infections (31%) and sepsis (19%). Clinically significant non-hematological toxicities were uncommon and predominantly low grade.
3:41AM A.O. Smith executive chairman to retire, Ajita Rajendra named chairman and CEO (AOS) 52.97 : Co announces that Executive Chairman Paul Jones has decided to retire following the company's Annual Shareholders Meeting in April 2014.
The company's Board of Directors has elected Ajita Rajendra as chairman of the Milwaukee-based water technology company effective upon Jones' retirement. Rajendra will continue to serve as president and chief executive officer of the company. Jones will remain a member of the company's Board of Directors.
3:38AM Celgene reports REVLIMID-Treated patients with deletion-5q MDS who achieve transfusion-independence of at least 26 weeks and AML-free survival associated with cytogenetic response (CELG) 170.01 : Co presents results from a retrospective analysis of patients with International Prognostic Scoring System Low- or Intermediate-1-risk myelodysplastic syndromes with del(5q) treated with REVLIMID were presented at the American Society of Hematology annual meeting in New Orleans, La.
In the analysis, 286 patients from the MDS-003 and MDS-004 studies received lenalidomide from the study start. Of the total, 181 were evaluable for both cytogenic response and red-blood cell transfusion independence (RBC-TI) of at least 26 weeks, (88 patients from MDS-003 and 93 patients from MDS-004).
Of those 181 patients, 130 had isolated del(5q), 32 had del(5q) plus 1 additional abnormality, 14 had del(5q) plus more than 1 additional abnormality, and 5 patients had missing cytogenetics at baseline.
A total of 103 patients (56.9%) achieved a CyR (complete and partial response). The likelihood of a CyR was increased in patients who achieved RBC-TI of at least 26 weeks compared with those who did not: 71% versus 31%. CyR rates were comparable across the isolated del(5q) and del(5q) plus 1 additional abnormality groups (59% vs. 63%, but lower in the del(5q) plus more than 1 additional abnormality group compared to these 2 groups combined. In patients with isolated del(5q) and del(5q) plus 1 additional abnormality, CyR was associated with a 41% and 58% reduction, respectively, in the risk of AML or death compared with no CyR. In all cytogenetic groups, median AML-free survival was longer in those who achieved CyR compared with non-responders, although it was not statistically significant in patients with del(5q) more than 1 additional abnormality. In a multivariate Cox proportional hazard model, factors associated with AML-free survival were CyR, total REVLIMID dose in cycle 1, lower IPSS-R categorization, female gender, and younger age.
3:32AM Ambit Biosciences announces 4 presentations including results of phase 2b randomized, open-label study of lower doses of quizartinib in flt3 itd positive relapsed refractory acute myeloid leukemia patients (AMBI) 8.31 : Co announces four oral presentations given at the 55th Annual ASH Conference in New Orleans, with data highlighting the Company's lead drug candidate, quizartinib.
Results of the Phase 2b Randomized, Open-Label, Study of Lower Doses of Quizartinib in Subjects with FLT3-ITD Positive Relapsed Acute Myeloid Leukemia (AML): The purpose of this study is to assess the efficacy and safety of lower doses of quizartinib in the treatment of patients 18-years or older with relapsed/refractory FLT3 ITD positive AML to further improve the benefit:risk assessment of quizartinib.
This preliminary analysis is based on data available through May 28, 2013 with a minimum of eight weeks of follow up since the last subject first visit. A total of 76 patients were enrolled from May 21, 2012 to March 27, 2013. Median age for all patients was 55 (19-77) and 92% were FLT3-ITD. 35 patients remained in follow-up at the time of the analysis, and are currently censored for overall survival. The following key information was presented:
For dose of 30mg:
3:22AM Volvo to sell Volvo Rents to private equity firm for ~SEK7.2 bln (VOLVY) 12.80 : Co announces it has agreed to sell Volvo Rents to the US private equity firm Platinum Equity for ~SEK 7.2 bln. At closing, net financial debt in the Volvo Group's Industrial Operation is expected to be reduced by the same amount.
The transaction is expected have a negative impact on the Group's operating income of ~SEK 1.5 bln in the fourth quarter of 2013.
3:17AM LDK Solar enters into further forbearance with noteholders (LDK) 1.38 : Co announces that it has entered into a new 30-day forbearance arrangement with holders of a majority in aggregate principal amount of its US$-Settled 10% Senior Notes due 2014. The new forbearance arrangement, which expires on January 9, 2014, relates to the interest payment due under the Notes on August 28, 2013. That interest payment is still unpaid. It is LDK Solar's intention to find a consensual solution to its obligations under the Notes as soon as possible and LDK Solar remains hopeful that it will be able to achieve that goal.
3:13AM lululemon athletica appoints Laurent Potdevin as CEO (LULU) 70.34 : Co announces its Board has appointed Laurent Potdevin as the company's Chief Executive Officer and a member of its Board of Directors. Potdevin will succeed Christine Day, who has served as the company's CEO since 2008 and who announced her intention to resign in June 2013. Potdevin is expected to step into his role as Chief Executive Officer in January 2014, and will become a director when he assumes his duties as CEO. Ms. Day is expected to remain with lululemon through the end of the company's fiscal year, ensuring a smooth transition. Potdevin comes to lululemon having most recently served as President of TOMS Shoes
In addition, Chip Wilson, lululemon's founder and the Chairman of its Board of Directors, informed the Board of Directors that he is resigning from the position of non-executive Chairman. Wilson will step down from the role effective prior to the company's annual meeting in June 2014. The Board has selected Michael Casey, Lead Director of the Board of Directors, as the next Chairman of the Board. Casey is expected to assume this role upon Wilson's resignation. This will allow time for an orderly transition and continuity in lululemon's leadership structure. Wilson will retain a seat on the Board of Directors.
3:00AM Savient Pharma reaches agreement on use of cash collateral (SVNT) 0.01 : Co announces that an agreement in principle has been reached by and among Savient, the Official Committee of Unsecured Creditors appointed in Savient's Chapter 11 case and the Unofficial Committee of Senior Secured Noteholders, whose members hold approximately 90% of Savient's senior secured notes. As part of the agreement, it is anticipated that the UCC will withdraw its objection and consent to entry of a final order authorizing Savient's continued use of cash collateral by the U.S. Bankruptcy Court for the District of Delaware. The Parties anticipate submitting a proposed Final Cash Collateral Order for consideration and approval by the Court on or before the hearing to consider the Final Cash Collateral Order, currently scheduled to take place on December 13, 2013. If entered by the Court, the proposed Final Cash Collateral Order would, among other things, provide for the distribution of proceeds from the sale of all or substantially all of Savient's assets and of additional amounts of cash collateral to the Secured Noteholders promptly after the Sale closing.
2:57AM Rambus and Micron (MU) sign license agreement (RMBS) 8.53 : Rambus (RMBS) and Micron Technology (MU) announce they have signed a broad patent cross license agreement. Under the agreement, Micron gains the right to use any Rambus patent for the manufacture of specified integrated circuit products, including any memory integrated circuit products. Certain of these memory products will enjoy a perpetual, paid-up license after the end of the initial term. The agreement requires quarterly royalty payments to Rambus over the next seven years capped at $10 million per quarter, with a rolling twelve-month cap fixed at $40 million, or $280 million during the initial term. In addition, Micron will have the option to extend the initial term of this agreement for additional renewal periods. As part of this agreement, the two companies have settled all outstanding patent and antitrust claims, and the agreement covers both Micron and Elpida products. Other terms and details of the agreement are confidential.
2:53AM Vitran to be acquired by Manitoulin Transport for $6.00 per share (VTNC) 5.44 : Vitran Corporation (VTNC) announces that it has entered into a definitive arrangement agreement under which 2398946 Ontario an affiliate of Manitoulin Transport, will acquire all of the issued and outstanding shares of Vitran for $6.00 in cash per share. The total transaction, including the assumption of Vitran's outstanding net debt of ~$29 million at October 31, 2013, is valued at ~$128 million. The $6.00 share price represents a 10.3% premium to Vitran's closing price on NASDAQ on December 9, 2013, and a 38.2% premium to the closing price on NASDAQ on September 20, 2013, the day before the announcement of the sale of Vitran's US LTL business.
2:48AM Samson Oil & Gas provides operational update on its North Stockyard Project (SSN) 0.45 : Co provides update on its NORTH STOCKYARD PROJECT in ND
Blackdog 3-13-14H (SSN WI 25.03%)
The Blackdog well successfully set and cemented the 7 inch casing in the Middle Bakken at 11,691 feet measured depth, 11,341 feet true vertical depth. Currently the 6 inch lateral portion of the well is being drilled at a depth of 15,258 feet. The forward plan is to drill the Blackdog to a total depth of 19,987 feet.
This well will be a middle Bakken lateral and is the infill location between the Rodney 1-14H well (SSN WI 27.18%) and the Sail and Anchor 1-13-14HBK well (SSN WI 25.03%).
Coopers 2-15-14HBK (SSN WI 27.7%),
The 22 stage plug and perf stimulation treatment commenced on December 3rd as planned. Currently eleven stages of the frac have been completed as of December 9th. Operations have been delayed due to extremely cold weather and the subsequent effect on operations including frac line sand manifolds being frozen. After completion of the Coopers well, the forward plan is to fracture stimulate the Tooheys, which will be a 24 stage sliding sleeve configuration.
Tooheys 4-15-14HBK (SSN WI 27.7%),
Fracture stimulation was expected to commence on December 8th, following the Coopers frac. With the weather delays experienced in the Coopers stimulation this frac has been pushed back. The completion configuration is a 24 stage sliding sleeve.
2:43AM American Airlines: US Airways Group 7.25% Conv Senior Notes due 2014 become convertible into shares of AAL stock (AAL) 24.60 : US Airways Group (LCC) announced that, as a result of the Company's merger with AMR Merger Sub, pursuant to which the Company became a wholly-owned subsidiary of American Airlines Group (AAL) as contemplated by the Agreement and Plan of Merger, dated as of Feb 13, 2013, its 7.25% Convertible Senior Notes due 2014 have become convertible into cash, shares of AAG common stock or a combination thereof at the Company's election.
2:39AM Pharmacyclics study results published in Lancet Oncology; progression free survival at 24 months was 96.3% in Phase 1b/2 trial (PCYC) 119.96 : Co announces that The Lancet Oncology published results of a study evaluating ibrutinib in previously untreated elderly patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The Phase 1b/2 open-label, multicenter study evaluated 31 patients, 65 years of age and older with CLL or SLL. The primary endpoint of the study was safety, as assessed by the frequency and severity of adverse events, while the secondary objectives assessed the clinical activity of single agent ibrutinib. Only one patient out of the 31 enrolled in this cohort has had progression of disease.
After a median follow-up of 22.1 months, the overall response rate for patients was 71%, which included 55% partial response, 3% nodular partial response and 13% complete response. An additional 13% of patients achived a partial response with lymphocytosis. The median time to initial response was 1.9 months; the median time to best response and complete response were 5.9 months and 12.0 months, respectively.
Across all patients, the estimated progression-free survival and overall survival at 24 months were 96.3%.
2:31AM Analysts Intl presents preclinical data on ALN-AT3 (ANLY) 6.44 : Co presents new pre-clinical data with ALN-AT3, a subcutaneously administered RNAi therapeutic targeting antithrombin for the treatment of hemophilia and rare bleeding disorders. In these new studies, repeat administration of ALN-AT3 was found to be well tolerated in Hemophilia A mice, with no adverse findings up to dose levels 200 times greater than levels required to achieve 50% AT knockdown. Further, the new studies demonstrate that ALN-AT3 administration achieves complete correction of the activated Partial Thromboplastin Time -- an ex vivo measure of blood coagulation that is significantly prolonged in hemophilia -- in HA mice. ALN-AT3 is a key program in the company's "Alnylam 5x15" product strategy, which is aimed at advancing five RNAi therapeutic programs directed toward genetically validated disease targets into clinical development, including programs in advanced stages, by the end of 2015.
Co presented data demonstrating that, in contrast to wild type mice, repeat administration of ALN-AT3 was very well tolerated in HA mice. Specifically, HA mice treated with ALN-AT3 exhibited no adverse events up to 100 mg/kg -- a dose that is 200-fold greater than the mouse ED50 and that essentially ablates AT protein levels in blood. In fact, 100% of the treated HA mice survived, with no adverse clinical signs or changes to body weight parameters. In WT mice (with intact coagulation systems), repeat administration of over 10 mg/kg ALN-AT3 led to greater than 90% knockdown of plasma AT, and resulted in the expected procoagulant phenotype and poor tolerability. This result was expected since AT knockout in mice and homozygous AT deficiency in humans are known to be embryonic lethal. To evaluate the potential reversal of ALN-AT3 efficacy, WT mice treated with 100 mg/kg ALN-AT3 were also treated with exogenous human AT protein. Co-administration of human AT conferred complete protection from prothrombotic adverse events observed in WT mice receiving ALN-AT3 alone, demonstrating that human AT protein could serve as a potential reversal agent for ALN-AT3, if needed. In addition, HA mice treated with ALN-AT3 exhibited significant reductions in aPTT relative to control HA mice. Specifically, the aPTT in HA mice, which is significantly prolonged, was corrected back to aPTT values observed in WT mice. Collectively, these data suggest a substantially expanded therapeutic index of AT knockdown in the hemophilia disease condition, and confirm the active effects for ALN-AT3 that are expected to reset insufficient thrombin generation in people with hemophilia.
Alnylam remains on track to begin a Phase I trial with ALN-AT3 early in 2014. Alnylam announced that it has received CTA approval from the MHRA for the initiation of the Phase I clinical study. The study will be conducted in the U.K. as a single- and multi-dose, dose-escalation study consisting of two parts.
2:25AM Agios Pharma presents preclinical data from lead programs (AGIO) 19.11 : Co presents that data from its lead programs were highlighted at the American Society of Hematology (ASH) Annual Meeting this week in New Orleans.
Two presentations featured in vivo efficacy data in acute myelogenous leukemia for the company's lead cancer metabolism programs targeting IDH1 and IDH2 mutations. In AML and other cancers, IDH1 and IDH2 mutations initiate and drive cancer growth by blocking maturation of primitive cells. The data presented at ASH demonstrate preclinical single agent and combination efficacy of Agios' IDH mutant inhibitors in patient-derived primary models of AML. Agios also presented data on AG-348, its lead inborn errors of metabolism program candidate focused on pyruvate kinase deficiency, a rare, inherited hemolytic anemia with no approved therapeutic options.
2:16AM Pacific Booker Minerals receives judgement regarding Morrison Copper/Gold mine (PBM) 3.90 : Co announces that the British Columbia Supreme Court has released the Judgement regarding the Company's challenge of the decision by the Provincial Government to turn down the proposed Morrison Copper/Gold Mine, announced by the provincial government on October 1st of last year.
The hearing was held before Justice Kenneth Affleck, Q.C. from August 7 to 9, 2013. Justice Affleck ruled that: "The petitioner is entitled to a declaration that the executive director's referral of the application for a certificate to the ministers and the ministers' decision refusing to issue the certificate failed to comport with the requirements of procedural fairness. There will be an order in the nature of certiorari quashing and setting aside the ministers' decision and an order remitting the petitioner's application for a certificate to the ministers for reconsideration. The petitioner is entitled to costs."
2:13AM Group 1 Auto acquires 6 franchises in Columbus Georgia; estimated to generate $150 mln in revs (GPI) 69.41 : Co announces the acquisition of Jay Automotive Group, Inc., in Columbus, Georgia, which include the following franchises: Jay Toyota Scion; Jay Buick GMC; Jay Subaru of Columbus; Jay Mazda; and Volvo of Columbus. The dealerships, which will operate as Rivertown Toyota; Rivertown Scion; Rivertown Buick GMC; Rivertown Subaru; Rivertown Mazda; and Volvo of Columbus, are expected to generate $150 million in estimated annual revenues.