Alkermes Wins Big on FDA Approval

Shares of Alkermes PLC (NASDAQ: ALKS) saw a handy gain to start out the week after the U.S. Food and Drug Administration (FDA) made a critical decision. Specifically, the FDA accepted for review the New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies.

Note that the FDA’s target action date for the ALKS 5461 NDA is January 31, 2019.

The 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. Alkermes did not submit any additional data or analyses to the FDA.

Excluding Monday’s move, Alkermes shares have underperformed the broad markets and were down 25% in the past 52 weeks. In just 2018 alone, the stock was down 22%.

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Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes, commented:

FDA’s filing of the ALKS 5461 application is a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years. We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients.

Shares of Alkermes were last seen up more than 7% at $45.80, with a consensus analyst price target of $54.27 and a 52-week range of $41.15 to $71.22.

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