| 2018-04-16 07:04:54|
ALKS 07:04 04/16 04/16/18
FDA rescinds Refusal to File letter for Alkermes depression drug
Alkermes announced this morning that the FDA accepted for review the New Drug Application for ALKS 5461, an oral investigational medicine for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. FDA's target action date for the ALKS 5461 NDA is Jan. 31, 2019. "FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA," the company said in a statement. Shares of Alkermes fell 22% on April 2 on news that the company received a Refusal to File letter from the FDA for ALKS 5461. The stock closed Friday down 43c to $42.53.
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