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
Fri, Jun. 3, 8:17 AM
- Ophthotech (NASDAQ:OPHT) upgraded to Overweight from Neutral by JPMorgan. Price target raised to $84 (45% upside) from $60.
- Intuitive Surgical (NASDAQ:ISRG) downgraded to Neutral from Buy by Goldman Sachs. Price target raised to $674 (5% upside) from $633.
- Celgene (NASDAQ:CELG) downgraded to Neutral from Buy by BTIG Research.
- Medtronic (NYSE:MDT) downgraded to Neutral from Buy by BTIG Research. $82 price target removed.
- Portola Pharmaceuticals (NASDAQ:PTLA) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $30 (7% upside) from $33.
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, May 5, 4:40 PM
Wed, May 4, 5:35 PM
- ABCO, ABTL, ACAD, ACET, AHS, AHT, AIRM, AL, ALEX, AMBR, AMH, ANET, APLE, ASYS, ATHX, ATVI, ATW, BBG, BCEI, BIO, BIOS, BLDR, BOJA, CAA, CARA, CERN, CINR, CLNE, CLVS, CMLS, CPA, CTRL, CYBR, CZR, DATA, DCT, DEPO, DIOD, DK, DKL, DV, DWA, EBS, ECOM, ED, EFC, EGAN, EGL, EGN, EGY, ELON, ENDP, ENV, EOG, ERII, ESL, EVC, EVDY, EVHC, FCE.A, FEYE, FISV, FLR, FPRX, FTD, GBDC, GEOS, GERN, GPRO, GSAT, GST, GUID, GXP, HLF, HTGC, ICPT, IMMR, IMPV, INAP, JCOM, LADR, LOCO, MAIN, MCHX, MDR, MDRX, MDVN, MELI, MHK, MITT, MNTX, MRIN, MSI, MTD, MTZ, NBIX, NGVC, NSTG, NWSA, OLED, OMED, OUT, OVAS, PACD, PCTY, PEGA, PETX, PKI, PMT, POST, PRSS, PTCT, PTLA, QLGC, RPTP, RRMS, RWT, SAAS, SEM, SEMG, SNCR, SPPI, SPWR, SPXC, SQ, SSNC, SWIR, TCRD, TEAM, TRMR, TRUE, TRQ, TRUP, TSRO, TWOU, UBNT, UEPS, UNXL, WAGE, WAIR, WEB, WIFI, WING, XNPT, Y, YELP
Fri, Apr. 8, 10:15 AM
- In a note to investors, Citi says the U.S. Treasury's recent pushback on inversion deals bodes well for merger and acquisition activity in small and mid cap biotechs as large caps move to beef up R&D pipelines.
- Likely targets over the next 12-18 months are: Ardelyx (ARDX +2.4%), Medivation (MDVN -0.2%), Ophthotech (OPHT +1.5%), Puma Biotechnology (PBYI +1.6%), Portola Pharmaceuticals (PTLA +3%), Ultragenyx Pharmaceutical (RARE -1.1%), Relypsa (RLYP -3.2%) and Versartis (VSAR -2.1%).
- In Citi's opinion, RLYP and MDVN head the list.
- Now read Medivation's Drug Pipeline is Severely Underrated And Undervalued
Fri, Apr. 1, 11:25 AM
- Cepheid (CPHD +6%) upgraded to Buy from Neutral by BTIG Research. Price target set at $42 (19% upside).
- Cardiovascular Systems (CSII +28.1%) upgraded to Buy from Underperform by Needham. Price target set at $16 (20% upside).
- United Health Services (UHS -0.6%) upgraded to Outperform from Market Perform by Wells Fargo.
- PRA Health Services (PRAH +1.4%) upgraded to Buy from Neutral by SunTrust Robinson Humphrey. Price target raised to $51 (17% upside) from $47.
- Dimension Therapeutics (DMTX +3.1%) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $10 (25% upside) from $12.
- Novartis (NVS -2%) downgraded to Neutral from Buy by UBS. Price target lowered to CHF72 (3% upside) from CHF100. Downgraded to Neutral from Buy by Citigroup.
- Intuitive Surgical (ISRG -0.2%) downgraded to Neutral from Buy by BTIG Research.
- ATyr Pharma (LIFE -1%) downgraded to Market Perform from Outperform by William Blair. Price target lowered to $8 (106% upside) from $42.
- Achaogen (AKAO -1.4%) downgraded to Market Perform from Outperform by Cowen & Co.
- Portola Pharmaceuticals (PTLA +4.1%) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $30 (40% upside) from $65.
- Quintiles Transnational Holdings (Q +1.9%) downgraded to Neutral from Buy by SunTrust Robinson Humphrey.
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.
Fri, Feb. 26, 5:23 AM
Thu, Feb. 25, 5:30 PM
Mon, Feb. 1, 8:56 AM
- Portola Pharmaceuticals (NASDAQ:PTLA) licenses lead development and commercial rights in Japan to andexanet alfa to Bristol-Myers Squibb (NYSE:BMY) and Pfizer (NYSE:PFE) to be developed as an antidote to anti-coagulants apixaban and other Factor Xa inhibitors. In a separate deal, the company enters into a clinical collaboration agreement with Bayer HealthCare (OTCPK:BAYRY) to include its Factor Xa inhibitor rivaroxaban.
- Under the terms of the agreement with BMY and PFE, Portola will receive an upfront payment of $15M, milestones up to $90M and double-digit royalties. Under the Bayer deal, Portola will receive an upfront payment of $5M and an undisclosed milestone based on regulatory approval. BMY and PFE own exclusive commercial rights.
- Three Factor Xa inhibitors are currently available in Japan, BMY and PFE's apixaban, Bayer's rivaroxaban and Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) endoxaban. No antidote is approved, however.
- Oral anticoagulants are a $800M market in Japan. A antidote is needed in certain situations such as emergency surgery, trauma or episodes of uncontrolled bleeding.
Dec. 18, 2015, 10:21 AM
- Portola Pharmaceuticals (PTLA +3.2%) completes it submission of its Biologics License Application (BLA) to the FDA for andexanet alfa, a Breakthrough Therapy-tagged reversal agent for anticoagulant Factor Xa inhibitors (J&J's Xarelto (rivaroxaban) tablets or Bristol-Myers Squibb's Eliquis (apixaban) tablets).
- Each year, as many as 4% of patients on Factor Xa inhibitors experience a major bleeding episode while another 1% may require emergency surgery. In the 12-month period ending April 2015, over 50K Americans treated with rivaroxaban or apixaban were admitted to the hospital due to bleeding. There is currently no FDA-approved rapid reversal agent for Factor Xa inhibitors.
- Andexanet alfa is administered via a continuous two-hour IV infusion.
- Previously: Portola Pharma anticoagulant antidote successful in Phase 3 study (April 8)
- Previously: Portola Pharma's andexanet alfa successful in second part of late-stage trial (June 22)
Dec. 4, 2015, 9:39 AM
- Portola Pharmaceuticals (PTLA -2%) prices its public offering of 3.125M shares of common stock at $48 per share. Underwriters over-allotment is an additional 468,750 shares. Closing date is December 9.
Nov. 10, 2015, 5:40 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
Other News & PR