Portola Pharmaceuticals, Inc. (PTLA - Free Report) announced that the FDA has extended the review period of its biologics license application (BLA) for the reversal agent of Factor Xa inhibitors, AndexXa (andexanet alfa), by 90 days. As a result, the regulatory body will now announce its decision by May 4, 2018 instead of the previously set deadline of Feb 3, 2018.
Notably, AndexXa has been developed for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Portola’s shares have significantly outperformed the industry so far this year. The stock has soared 144.5% compared with the broader industry’s increase of 9%.
The review date was extended to accommodate the resubmission of additional data provided by Portola in August. The resubmission was requested by the FDA in a complete response letter issued to Portola last August. In the letter, the FDA had requested for extra information related to product manufacturing.
Importantly, the regulatory body had also asked for more data to support the inclusion of direct Factor Xa inhibitor, Lixiana (edoxaban), and indirect Factor Xa inhibitor, Lovenox (enoxaparin), on the product label. Hence in view of this, the FDA has logically asked for additional time to review the application.
We remind investors that the BLA was based on positive data from two phase III ANNEXA studies that have evaluated the safety and efficacy of AndexXa in reversing the anticoagulant activity of the Factor Xa inhibitors, Xarelto (rivaroxaban), of Johnson and Johnson, Inc. (JNJ - Free Report) and Eliquis (apixaban) of Bristol-Myers Squibb Company (BMY - Free Report) in older healthy volunteers.
Significantly, AndexXa enjoys an Orphan Drug Status in the United States.
AndexXa is also under review in the EU with a marketing application filed in the third quarter of 2016. A response from the regulatory body is expected in the first half of 2018.
Per the company’s press release, more than 90,000 U.S. patients treated with oral Factor Xa inhibitors in 2016 were admitted to hospital due to excessive bleeding. It has also been estimated that more than 150,000 patients taking the injectable Factor Xa inhibitor, Lovenox, in the United States could benefit from an antidote annually.
With no currently approved antidote for Factor Xa inhibitors yet, there is an urgent, gaping unmet need for the same in the market.
Going ahead, we expect investors’ focus to remain on further details of AndexXa’s regulatory aspects.
Zacks Rank & Key Pick
Portola carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Corcept Therapeutics Incorporated (CORT - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Corcept’s earnings per share estimates have been revised upward from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has skyrocketed 146.5% year to date.
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