BioCentury
ARTICLE | Clinical News

FDA accepts NDA for Alkermes' depression candidate, reversing refusal

April 20, 2018 4:32 PM UTC

FDA 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 April 16. It has not rebounded from losses sustained April 2, when it lost 22% to $45.23 on news of the refusal-to-file letter...

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