FDA rescinds Refusal to File letter for Alkermes depression drug
Alkermes (ALKS) 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.
Credit Suisse analyst Vamil Divan raised his price target for Alkermes to $63 after the FDA accepted the new drug application filing for ALKS 5461 two weeks after sending a Refusal to File letter. The analyst says some of his confidence in the drug is renewed, but he admits this is an “unusual situation.” An Advisory Committee meeting to discuss the application will likely be held in Q4 and will be important indicator for the FDA’s ultimate approval decision, Divan tells investors in a research note. He maintains an Outperform rating on Alkermes.
Goldman Sachs analyst Terence Flynn views the FDA accepting Alkermes’ new drug application for ALKS 5461 as an incremental positive. The analyst, however, keeps a Neutral rating on Alkermes with a $44 price target. While ALKS 5461 for the adjunctive treatment of major depressive disorder can now move into the review process, the FDA will most likely convene an advisory panel in Q4 to review the filing, Flynn tells investors in a research note. He believes there’s still a possibility that the FDA requests an additional trial from Alkermes.
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. In Monday’s pre-market trading shares are up 13% to $48.
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