Why the FDA Is Dragging Alkermes Down

Alkermes PLC (NASDAQ: ALKS) shares dropped 8% early on Friday in premarket trading after the company announced the results from its most recent meeting with the U.S. Food and Drug Administration.

Alkermes was meeting with the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the FDA, to review Alkermes’ New Drug Application (NDA) for ALKS 5461.

Ultimately, the committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes/ 21 No).

For some quick background, ALKS 5461 is a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.

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Richard Pops, chief executive officer of Alkermes, commented:

We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the Advisory Committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants. We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.

Shares of Alkermes closed Thursday at $40.83, with a consensus analyst price target of $50.30 and a 52-week range of $37.01 to $71.22. Following the announcement, the stock was down 8% at $37.50 in early trading indications Friday.

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