Portola Pharma Receives CRL From FDA For BLA For AndexXa; Stock Plunges

(RTTNews) - Portola Pharmaceuticals Inc. (PTLA) said that it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding its Biologics License Application or BLA for AndexXa or andexanet alfa.

PTLA closed Wednesday's regular trading at $23.66, down $2.95 or 11.09 percent. In the after-hours trade, the stock further dropped $3.02 or 12.75 percent.

An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, rivaroxaban, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Currently, there is no FDA-approved antidote for Factor Xa inhibitors.

In the CRL for AndexXa, the FDA requested that Portola provide additional information primarily related to manufacturing. The agency also asked for additional data to support inclusion of edoxaban and enoxaparin in the label, and indicated it needs to finalize its review of the clinical amendments to Portola's post-marketing commitments that recently were submitted.