Alkermes Submits NDA For Depression Candidate To The FDA
Zacks Investment Research | Jan 31, 2018 09:08PM ET
Alkermes plc (NASDAQ:ALKS) announced submission of a new drug application (NDA) to the FDA for its pipeline candidate, ALKS 5461. The NDA seeks an FDA approval for the candidate’s usage in the adjunctive treatment of major depressive disorder (MDD). If approved, this would be the first therapeutic option for patients with depression with a novel mechanism of action.
We remind investors that in October 2013, the FDA had granted a Fast Track status to ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to the standard antidepressant therapies. The Fast Track designation from the FDA facilitates the development and expedites the review of drugs that are intended to treat serious conditions and address medical needs.
Alkermes’ shares have underperformed the Zacks Investment Research
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