Portola Pharmaceuticals (PTLA) Pummeled After Betrixaban Fails Phase 3 APEX Study
Shares of Portola Pharmaceuticals (PTLA) were off -7.97 or -27.85 percent to $20.65 per share in this morning’s premarket after trading was halted in the stock pending news. The company subsequently released the results from a Phase 3 APEX trial of its drug Betrixaban, which failed to achieve its primary endpoint in the first cohort. Portola Pharmaceutical stock closed at $28.62, down -0.77 or -2.62 percent in Wednesday’s regular trading session.
Portola announced the topline data from the Phase 3 APEX or Acute Medically Ill VTE Prevention study with Extended Duration Betrixaban. The study evaluated whether oral betrixaban was more effective in extended duration anticoagulation than the standard care anticoagulation regimen of injectable enoxaparin for the prevention of venous thromboembolism or VTE. VTE consists of blood clots in patients with serious conditions such as heart failure, infection or pulmonary disease.
The APEX study, which had enrollment of 7,513 patients in over 450 clinical sites is separated into two parts: Cohort 1, with patients registering elevated D-dimer levels, about 62 percent of the study population, and Cohort 2, patients with elevated D-dimer levels under the age of 75, approximately 91 percent of the study population.
The results of Cohort 1, which achieved a value of 0.054, did not meet the threshold. Cohort 2 as well as the overall study population achieved values of 0.029 and 0.006 respectively showing no statistical difference in major bleeding between betrixaban and enoxaparin in any of the three patient groups.
Bill Lis, Portola’s Chief Executive Officer stated in the company’s press release that, “While we understand that the interpretation of these statistical and clinical results will be subject to discussions with regulatory agencies, we and the APEX Study academic leadership believe that the data in Cohort 1 were sufficiently strong to support a full assessment of Cohort 2 and the overall study population. We believe the overall robustness of the efficacy and safety results in this high-risk patient population, including the positive net clinical benefit observed, provide ample evidence to support the submission of an NDA later this year.”
VTE is responsible for over 150,000 deaths in acutely ill patients in the G-7 countries each year. Over 20 million acutely ill medical patients are at risk of developing VTE while in the hospital or after being discharged even with the use of injectable enoxaparin in the hospital.
Portola Pharmaceuticals certainly has a lot riding on the success of bentrixaban. The failure of the first cohort of the Phase 3 APEX study has significantly affected the company’s stock price and valuation, losing almost -30 percent in this morning’s premarket.
Other News About PTLA
Portola Pharmaceuticals Announces Biologics License Application for Andexanet Alfa Accepted for Review by FDA
The FDA is expected to take action on the application by the PDUFA action date of August 17th, 2016.
Portola Pharmaceuticals posts 4Q loss
Company posted a loss of -$1.23 per share or -$66.1 million in the fourth quarter.
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