FDA approves Portola's Andexxa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) added about $570 million in market cap on May 4 after FDA granted accelerated approval to a resubmitted BLA for its Andexxa andexanet alfa.

The agency approved Andexxa to reverse the anticoagulant activity of Factor Xa inhibitors Xarelto rivaroxaban and Eliquis apixaban in patients with life-threatening or uncontrolled bleeding. Andexxa's label includes a boxed warning for thromboembolic risks, ischemic risks, cardiac arrest and sudden death...