FDA reverses Alkermes refuse-to-file decision

FDA has accepted for review an NDA for ALKS 5461 from Alkermes plc (NASDAQ:ALKS) as an adjunctive treatment of major depressive disorder, reversing the agency’s decision to refuse to file the application. The decision will not affect the review's timing, Alkermes Chairman and CEO Richard Pops said on a conference call. The PDUFA date is Jan. 31, 2019, and the company expects an advisory committee meeting in 4Q18, Pops said.

Alkermes was up $1.90 to $44.43 on Monday. It has not rebounded from losses sustained April 2, when it lost 22% to $45.23 on news of the refusal-to-file letter...