ARTICLE | Company News

Portola sinks under AndexXa uncertainty

March 1, 2018 11:31 PM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) dropped $10.76 (25%) to $31.56 Thursday, losing over $700 million in market cap, after it disclosed late Wednesday that FDA may require an additional randomized study of AndexXa andexanet alfa to reverse the anticoagulant activity of Factor Xa inhibitors.

During Portola's earnings conference call Wednesday, CEO William Lis said the company "didn't get clarity" from FDA on its trial request, such as whether the trial would be pre- or post-approval. He said the agency did confirm that a resubmitted BLA for AndexXa is still being reviewed for accelerated approval with the same May 4 PDUFA date as disclosed in December...

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