Portola slammed by a surprising FDA rejection for its anti-anticoagulant
Portola Pharmaceuticals waited until late Wednesday to spread the word that the FDA has rejected its marketing application for its anti-anticoagulant andexanet alfa, a surprising setback for a company that had been confidently assuring analysts of its likely success.
Their antidote–which earned the FDA’s breakthrough therapy designation–is a molecule that is designed to quickly disarm Factor Xa anticoagulants like Eliquis and Xarelto, blocking their activity when needed to prevent excessive bleeding. Portola $PTLA got a big bounce in late 2014 when it announced that the first leg of the Phase III was a success. And they followed up in the spring of 2015 with a confirmatory leg of the Phase III program that reassured analysts that the South San Francisco-based company was on the right track.
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