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
Tue, Aug. 30, 7:10 AM
- Portola Pharmaceuticals (NASDAQ:PTLA) is up 6% premarket, albeit on only 1,355 shares, in response to it announcement of positive interim results from a Phase 3b/4 study, ANNEXA-4, assessing the Factor Xa inhibitor antidote AndexXa (andexanet alfa) in reversing acute major bleeding associated with the anticoagulant. The data were presented today at the European Society of Cardiology Congress in Rome.
- A preliminary analysis on interim results from 67 patients (47 evaluated for efficacy) showed a 30-minute bolus of AndexXa rapidly and substantially reversed anti-Factor Xa activity and sustained the reversal when followed by a 120-minute infusion. The majority of patients (79%) achieved good or excellent hemostasis (bleeding stopped) over a 12-hour period after the infusion.
- Stuart Connolly, M.D., study Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario says, "In this preliminary analysis, AndexXa was effective in rapidly reversing anti-Factor Xa inhibitor activity and restoring normal blood clotting in real-world patients with Factor Xa-related bleeding. Based on these interim results, we believe that ANNEXA-4 is on track to achieve its co-primary endpoints. The hemostatic efficacy results are especially important because no FDA- or EMA-approved antidote is available for these patients and no existing therapies, including plasma-derived products for warfarin reversal, have demonstrated reversal of Factor Xa inhibitor activity or clinical efficacy and safety."
- The interim data showed no AndexXa-associated infusion reactions and no patients developed antibodies to Factor Xa or Factor X or neutralizing antibodies to AndexXa. During the 30-day follow-up period, thrombotic events occurred in 12 patients (18%) while 10 patients died (15%), both within the expected range for this population.
- On August 17, the company received a Complete Response Letter (CRL) from the FDA regarding its Biologic License Application (BLA) for AndexXa. It plans to meet with the agency as soon as possible to resolve the issues and clarify a path forward. Its Marketing Authorization Application (MAA) is currently under review in Europe.
- Management will host a webcast today at 11:00 am ET to discuss the results.
Fri, Aug. 26, 7:26 AM
- Bayer AG (OTCPK:BAYRY) upgraded to Buy from Neutral by Citigroup.
- Allscripts (NASDAQ:MDRX) upgraded to Outperform from Market Perform by Leerink Swann. Price target raised to $17 (32% upside) from $16.
- Healthways (NASDAQ:HWAY) upgraded to Equal Weight from Underweight by Barclays. Price target raised to $27 (10% upside) from $12.
- Cardiovascular Systems (NASDAQ:CSII) upgraded to Outperform from Market Perform by Leerink Swann. Price target is $30 (26% upside).
- Allergan plc (NYSE:AGN) upgraded to Buy from Neutral by Mizuho Securities. Price target raised to $318 (35% upside) from $248.
- Healthways (HWay) downgraded to Sell from Neutral by UBS. Price target raised to $22.50 (8% downside risk) from $19.
- ResMed (NYSE:RMD) downgraded to Underperform from Hold by Jefferies. Price target lowered to $58 (15% downside risk) from $60.
- Relypsa (NASDAQ:RLYP) downgraded to Hold from Buy by Stifel Nicolaus. Price target is $32 (0% upside).
- Portola Pharmaceuticals (NASDAQ:PTLA) downgraded to Neutral from Buy by Citigroup. Price target lowered to $24 (21% upside) from $40.
- Juniper Pharmaceuticals (NASDAQ:JNP) downgraded to Neutral from Buy by H.C. Wainwright. Price target is $6.75 (17% upside).
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
Mon, Aug. 8, 5:35 PM
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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
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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