Portola Pharmaceuticals, Inc. PTLA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has extended the review timeline of its marketing authorization application (MAA) for Ondexxya (andexanet alfa).
Following this announcement on Tuesday, shares of Portola declined 6.6%. In fact, the stock has plummeted 59.9% so far this year, wider than the industry’s decline of 11.7%.
Post this move, the CHMP will issue a list of questions to Portola regarding the data submitted for Ondexxya. The company will need to provide a response to the regulatory body by Jan 29, 2019. The reply will then be assessed by the CHMP within the next 30 days post which, the regulatory agency will declare its decision on Feb 28, 2019.
Portola continues to focus on addressing the committee’s queries and is planning for a potential approval in Europe by early next year.
Ondexxya is currently being evaluated to check the reversal of the anticoagulant activity of the Factor Xa inhibitors, Xarelto (rivaroxaban) — jointly developed by Bayer and Johnson and Johnson JNJ — and Eliquis (apixaban), in patients suffering uncontrolled or life-threatening bleeding.
Notably, in May 2018, the drug received a nod in the United States and is marketed under the trade name of Andexxa. Significantly, AndexXa enjoys an Orphan Drug status in the United States.
Another product in Portola’s portfolio is Bevyxxa (betrixaban). This drug is the first and the only oral, once-daily Factor Xa inhibitor, approved for the treatment of venous thromboembolism (VTE) in adult patients, who are hospitalized with an acute medical illness.
Moreover, in September 2018, the FDA granted an orphan drug designation to Portola’s investigational Syk/JAK inhibitor, cerdulatinib. The candidate is currently being examined for the treatment of peripheral T-cell lymphoma.
Cerdulatinib especially prevents two key cell signaling pathways implicated in hematologic malignancies and autoimmune diseases. Earlier this month, Portola posted interim data from the phase IIa program on cerdulatinib at the American Society of Hematology’s (ASH) Annual Meeting in San Diego.
Zacks Rank and Other Stocks to Consider
Portola currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the same sector include BioSpecifics Technologies Corp BSTC and Hikma Pharmaceuticals Plc HKMPF, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings estimates have been revised 9.6% upward for 2018 and 16.8% for 2019 over the past 60 days. The stock has surged 41.1% year to date.
Hikma’s earnings estimates have moved 22.1% north for 2018 and 17.6% for 2019 over the past 60 days. The stock has soared 59% year to date.
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