Complete response delays Portola's AndexXa

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) slipped $3.57 (15%) to $20.12 on Thursday after it said FDA issued a complete response letter for AndexXa andexanet alfa, which is under review to reverse the anticoagulant activity of direct and indirect Factor Xa inhibitors.

On a conference call Thursday, CEO William Lis said the letter's "dominant portion" outlined FDA's concerns about manufacturing of the reverse anticoagulant. He noted that the agency conducted a pre-approval inspection in April that identified "very few, if any non-critical" issues. ...