We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Portola Betrixaban Accepted for Review in U.S. & EU, Stock Up
Read MoreHide Full Article
Shares of Portola Pharmaceuticals, Inc. surged 33.8% after the company’s new drug application for its oral, once-daily Factor Xa inhibitor anticoagulant, betrixaban, was accepted under priority review by the FDA. Note that Portola is looking to get betrixaban approved for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
Portola’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical - Drugs industry. Specifically, Portola has plunged 51.3% during this period, while the industry lost 24.1%.
We note that priority review shortens the FDA review period from the standard 10 months to just 6 months. Therefore, with the FDA granting priority review, a final decision on the approval of the candidate should be out by Jun 24, 2017.
In addition, Portola’s marketing authorization application for betrixaban for extended-duration prophylaxis of VTE in adults with acute medical illness and risk factors for VTE was validated by the European Medicines Agency (EMA). The EMA's Committee for Medicinal Products for Human Use will review the regulatory application during a standard 210-day review period.
We are encouraged by the simultaneous acceptance of betrixaban for review in the U.S. and the EU. These approvals will be a huge boost for the company seeing that betrixaban will be the first anticoagulant to be approved for in-hospital and extended-duration VTE prophylaxis in high-risk acute medically ill patients.
According to information provided by the company in its press release, an estimated 24 million acute medically ill patients are hospitalized annually in the G7 countries and are at risk of developing VTE, either while in the hospital or following discharge. Moreover, regardless of the standard use of injectable enoxaparin and other heparins in the hospital, over 1 million VTEs and 150,000 VTE-related deaths occur each year in these patients in the G7 countries.
Portola’s stock got a much-needed boost from the latest development. We remind investors that the company’s shares were under pressure ever since this August, when the FDA issued a complete response letter for AndexXa (EU trade name: IndexXa), which was being developed as an antidote for Factor Xa inhibitors, in cases where reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required.
Portola plans to resubmit the biologics license application for AndexXa in the second quarter of 2017.
AndexXa is currently under review in the EU with a response expected next year. Portola is seeking conditional approval for AndexXa in the EU through the centralized procedure.
Note that Portola recently signed a $50 million loan agreement with Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) , under which Bristol-Myers and Pfizer will each loan Portola $25 million for development and clinical studies on AndexXa. We note that Portola had previously entered into clinical collaboration agreements with Bristol-Myers and Pfizer to support phase II and registrational studies on AndexXa in the U.S. and Europe.
Moreover, it has a collaboration agreement with these two companies for the development and commercialization of AndexXa in Japan.
Currently available anticoagulants in the market include Bristol-Myers/Pfizer’s Eliquis among others.
Zacks Rank & a Key Pick
Portola currently carries a Zacks Rank #3 (Hold). Sucampo Pharmaceuticals, Inc. is a better-ranked stock in this industry sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold.Be among the very first to see them >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Portola Betrixaban Accepted for Review in U.S. & EU, Stock Up
Shares of Portola Pharmaceuticals, Inc. surged 33.8% after the company’s new drug application for its oral, once-daily Factor Xa inhibitor anticoagulant, betrixaban, was accepted under priority review by the FDA. Note that Portola is looking to get betrixaban approved for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
Portola’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical - Drugs industry. Specifically, Portola has plunged 51.3% during this period, while the industry lost 24.1%.
We note that priority review shortens the FDA review period from the standard 10 months to just 6 months. Therefore, with the FDA granting priority review, a final decision on the approval of the candidate should be out by Jun 24, 2017.
In addition, Portola’s marketing authorization application for betrixaban for extended-duration prophylaxis of VTE in adults with acute medical illness and risk factors for VTE was validated by the European Medicines Agency (EMA). The EMA's Committee for Medicinal Products for Human Use will review the regulatory application during a standard 210-day review period.
We are encouraged by the simultaneous acceptance of betrixaban for review in the U.S. and the EU. These approvals will be a huge boost for the company seeing that betrixaban will be the first anticoagulant to be approved for in-hospital and extended-duration VTE prophylaxis in high-risk acute medically ill patients.
According to information provided by the company in its press release, an estimated 24 million acute medically ill patients are hospitalized annually in the G7 countries and are at risk of developing VTE, either while in the hospital or following discharge. Moreover, regardless of the standard use of injectable enoxaparin and other heparins in the hospital, over 1 million VTEs and 150,000 VTE-related deaths occur each year in these patients in the G7 countries.
Portola’s stock got a much-needed boost from the latest development. We remind investors that the company’s shares were under pressure ever since this August, when the FDA issued a complete response letter for AndexXa (EU trade name: IndexXa), which was being developed as an antidote for Factor Xa inhibitors, in cases where reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required.
PORTOLA PHARMA Price and Consensus
PORTOLA PHARMA Price and Consensus | PORTOLA PHARMA Quote
Portola plans to resubmit the biologics license application for AndexXa in the second quarter of 2017.
AndexXa is currently under review in the EU with a response expected next year. Portola is seeking conditional approval for AndexXa in the EU through the centralized procedure.
Note that Portola recently signed a $50 million loan agreement with Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) , under which Bristol-Myers and Pfizer will each loan Portola $25 million for development and clinical studies on AndexXa. We note that Portola had previously entered into clinical collaboration agreements with Bristol-Myers and Pfizer to support phase II and registrational studies on AndexXa in the U.S. and Europe.
Moreover, it has a collaboration agreement with these two companies for the development and commercialization of AndexXa in Japan.
Currently available anticoagulants in the market include Bristol-Myers/Pfizer’s Eliquis among others.
Zacks Rank & a Key Pick
Portola currently carries a Zacks Rank #3 (Hold). Sucampo Pharmaceuticals, Inc. is a better-ranked stock in this industry sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>