Portola Pharmaceuticals (PTLA) - NASDAQ
  • Fri, May 27, 9:13 AM
    • Portola Pharmaceuticals (NASDAQ:PTLA) is up 14% premarket on light volume in response to its announcement of final results from the Phase 3 APEX study assessing extended-duration oral anticoagulant betrixaban compared to Sanofi's (NYSE:SNY) Lovenox (enoxaparin) injection for the prevention of blood clots (venous thromboembolism or VTE) in acute medically ill patients. The data were presented at the 62nd Annual International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Meeting in Montpellier, France.
    • The results showed a consistent and significant reduction in VTE with betrixaban with no statistical difference in major bleeding between the betrixaban and enoxaparin arms. According to the company, over half of VTE events occur after discontinuation of enoxaparin and hospital discharge.
    • Portola intends to file marketing applications in the U.S. and Europe later this year.
    • Previously: Trading in Portola Pharma halted pending news; Phase 3 APEX study of extended-duration betrixaban fails to achieve primary endpoint in first cohort; shares off 24% premarket (March 24)
    | Fri, May 27, 9:13 AM | 14 Comments
  • Fri, May 27, 9:12 AM
    | Fri, May 27, 9:12 AM
  • Thu, Mar. 24, 12:47 PM
    | Thu, Mar. 24, 12:47 PM | 2 Comments
  • Thu, Mar. 24, 9:18 AM
    | Thu, Mar. 24, 9:18 AM | 3 Comments
  • Thu, Mar. 24, 7:00 AM
    • Trading in Portola Pharmaceuticals (NASDAQ:PTLAhalted at 6:55 am ET this morning pending news.
    • Update: Top-line results from the Phase 3 APEX study evaluating the superiority of extended-duration anticoagulation with oral betrixaban compared to standard-of-care anticoagulation with injectable enoxaparin [Sanofi's (NYSE:SNY) Lovenox (enoxaparin sodium injection] for the prevention of blood clots [venous thromboembolism (VTE)] in acute medically ill patients failed to achieve its primary endpoint in the first cohort.
    • The 7,513-subject study was designed to assess the relative risk of the two therapies as measured by a composite endpoint of ultrasound-detected (asymptomatic) proximal deep venous thrombosis (DVT), symptomatic DVT, non-fatal pulmonary embolism (PE) or VTE-related death in high-risk acute medically ill patients treated with oral betrixaban for 35 - 47 days compared to standard-of-care- injectable enoxaparin for 6 - 14 days.
    • The study population consisted of three pre-specified patient groups: Cohort 1 - patients with elevated D-dimer levels (62% of the population); Cohort 2: patients with elevated D-dimer levels aged at least 75 years (91% of the population) and the overall study population. D-dimer is a test for inappropriate blood clots.
    • The trial incorporated an enrichment strategy and statistical analysis plan derived from FDA guidance. Per the protocol, the primary efficacy analysis was performed on Cohort 1. The p value had to be no higher that 0.05 in order to test Cohort 2 which, in turn, had to have a p value no higher than 0.05 in order to test the overall study population.
    • The p value in Cohort 1 was 0.054, slightly above the threshold to proceed to Cohort 2, which had a p value of 0.029. The overall population's p value was lower still, 0.006. The relative risk calculation favored betrixaban in all three cohorts, showing a 19 - 24% lower risk of events compared to enoxaparin.
    • The company believes the data in Cohort 1 were strong enough to support the full assessment in Cohort 2 and the overall study population. It also believes the data are robust enough to support a New Drug Application (NDA) later this year. As such, it intends to discuss the data with regulatory agencies.
    • According to the company, ~20M acute medically ill patients in the G7 countries are at risk of developing VTE while hospitalized or following discharge. More than 1M VTEs and 150K VTE-related deaths occur in this population each year despite the use of injectable enoxaparin.
    • Fast Track-tagged betrixaban is a once-daily orally administered Factor Xa inhibitor anticoagulant.
    • Management will host a conference call this morning at 8:30 am ET to discuss the study.
    • Shares are down 24% premarket on robust volume.
    | Thu, Mar. 24, 7:00 AM | 17 Comments
  • Nov. 10, 2015, 5:40 PM
    | Nov. 10, 2015, 5:40 PM | 2 Comments
  • Feb. 5, 2015, 5:35 PM
    • Top gainers, as of 5:15 p.m.: PTLA +16.4%. GSB +15.6%. TWTR +11.4%. UBNT +10.8%. YRCW +8.3%.
    • Top losers, as of 5:15 p.m.: P -21.0%. FWM -15.0%. MXWL -14.6%. NTGR -13.5%. CTRL -10.4%.
    | Feb. 5, 2015, 5:35 PM
  • Jan. 9, 2015, 9:10 AM
    | Jan. 9, 2015, 9:10 AM | 4 Comments
  • Oct. 1, 2014, 12:46 PM
    | Oct. 1, 2014, 12:46 PM
  • Oct. 1, 2014, 12:10 PM
    • Thinly-traded Portola Pharmaceuticals (PTLA +15.5%) jumps on a 2x surge in volume albeit on turnover of less than 600K shares in response to its announcement of positive results from a Phase 3 clinical trial evaluating the safety and efficacy of andexanet alfa as an antidote to a Factor Xa inhibitor.
    • Top-line efficacy data demonstrated that an IV bolus of andexanet alfa immediately and significantly reduced the anticoagulation activity of Bristol-Myers Squibb (BMY -1.4%) and Pfizer's (PFE -1.3%) direct Factor Xa inhibitor Eliquis (apixaban). The results were highly statistically significant.
    • CEO William Lis says, "Andexanet alfa represents a potential important advance to the field of anticoagulation for Factor Xa inhibitor patients who suffer a major bleeding episode or those requiring emergency surgery."
    • The company expects to file a BLA with the FDA for the Breakthrough Therapy-designated product candidate by the end of 2015.
    | Oct. 1, 2014, 12:10 PM | 2 Comments
  • Oct. 16, 2013, 10:58 AM
    • Portola Pharmaceuticals (PTLA -7.1%) falls sharply after announcing a $100M public offering.
    • The deal will reportedly include shares from selling stockholders.
    • The company intends to use a portion of the proceeds to "support the pursuit of an accelerated approval process for Andexanet alfa." (PR)
    | Oct. 16, 2013, 10:58 AM
  • Oct. 9, 2013, 8:26 AM
    | Oct. 9, 2013, 8:26 AM
  • Jun. 27, 2013, 3:06 PM

    Portola Pharmaceuticals (PTLA +10.1%) moves up after saying late yesterday that it had entered into a clinical collaboration agreement with Daiichi Sankyo (DSNKY.PK) to conduct a Phase 2 study of its investigational Factor Xa inhibitor antidote PRT4445, or andexanet alfa. The study will at several different doses to reverse the anticoagulant effects of Daiichi Sankyo's edoxaban in healthy volunteers.

    | Jun. 27, 2013, 3:06 PM
  • Jun. 27, 2013, 2:44 PM

    Portola Pharmaceuticals (PTLA +10.1%) moves up after saying late yesterday that it had entered into a clinical collaboration agreement with Daiichi Sankyo (DSNKY.PK) to conduct a Phase 2 study of its investigational Factor Xa inhibitor antidote PRT4445, or andexanet alfa. The study will at several different doses to reverse the anticoagulant effects of Daiichi Sankyo's oral direct Factor Xa inhibitor edoxaban in healthy volunteers.

    | Jun. 27, 2013, 2:44 PM
Company Description
Portola Pharmaceuticals, Inc. is a biopharmaceutical company that engages in the development and commercialization of novel therapeutics in the areas of thrombosis and other hematologic disorders and inflammation. Its development-stage portfolio consists of the compounds including Betrixaban, a... More
Sector: Healthcare
Industry: Drug Related Products
Country: United States