Portola Pharmaceuticals - Liking The Risk-Reward For 2016 And Beyond
DoctoRx • 34 Comments
DoctoRx • 34 Comments
Portola: Who's Afraid Of Praxbind?
Kanak Kanti De • 13 Comments
Kanak Kanti De • 13 Comments
Thu, Aug. 18, 12:47 PM
Thu, Aug. 18, 11:00 AM
Thu, Aug. 18, 9:17 AM
Thu, Aug. 18, 6:43 AM
- Portola Pharmaceuticals (NASDAQ:PTLA) plummets 18% premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) seeking approval of anticoagulant reversal agent AndexXa (andexanet alfa).
- The company says most of the requested information relates to manufacturing although the agency also wants more data to support inclusion of edoxaban [Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) Savaysa] and enoxaparin [Sanofi's (NYSE:SNY) LOVENOX] in the label. It also stated that it needs more time to complete its review of the clinical amendments to Portola's post-marketing commitments that were submitted recently.
- Andexanet alfa is a modified human Factor Xa molecule that acts as a decoy to target and sequester, with high specificity, Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to inhibit Factor Xa and normal hemostatic processes are restored.
- Management will host a conference call this morning at 8:30 am ET to discuss the situation.
- Previously: Portola down 10% ahead of FDA action on AndexXa (Aug. 17)
Wed, Aug. 17, 3:50 PM
- Flashing an enormous red flag to investors, Portola Pharmaceuticals (PTLA -10.4%) is showing unsettling bearish action before the expected FDA announcement today on the company's marketing application for anticoagulant reversal agent AndexXa (andexanet alfa). Today's action is wide and loose on 4x higher volume, not what you want to see before a binary event. Longs better hedge their positions immediately.
Wed, Aug. 17, 9:27 AM
- Portola Pharmaceuticals (NASDAQ:PTLA) is ahead 3% premarket on light volume. Today is the FDA's PDUFA date for the company's marketing application seeking approval of anticoagulant reversal agent AndexXa (andexanet alfa). Commercial launch preparations are underway.
- Read now An ER Physician's Evaluation Of Portola's Q2 Earnings And Its Near-Term Catalyst
Tue, Aug. 9, 4:34 PM
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, 9:12 AM
Thu, Mar. 24, 12:47 PM
Thu, Mar. 24, 9:18 AM
Thu, Mar. 24, 7:00 AM
- Trading in Portola Pharmaceuticals (NASDAQ:PTLA) halted 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.
Nov. 10, 2015, 5:40 PM
Feb. 5, 2015, 5:35 PM
Jan. 9, 2015, 9:10 AM
Oct. 1, 2014, 12:46 PM
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
Industry: Drug Related Products
Country: United States