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Feb. 1, 2019, 4:56 p.m. EST

Alkermes shares fall after FDA blocks antidepressant approval

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By Wallace Witkowski


Alkermes PLC /zigman2/quotes/205084517/composite ALKS +5.88% said late Friday that the Food and Drug Administration told the biotech drug maker that it is unable to approve one of its antidepressants at this time. Alkermes shares, which fell 4.8% after hours, had closed Friday up 0.6% at $33.08. The FDA said it was unable to approve the marketing application for the drug candidate ALKS 5461 "in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness" of the drug to treat major depressive disorder, according to Alkermes. The company said it would meet with the FDA to determine "a viable path forward" for the drug.

US : U.S.: Nasdaq
$ 19.28
+1.07 +5.88%
Volume: 1.53M
March 5, 2021 4:00p
P/E Ratio
Dividend Yield
Market Cap
$3.07 billion
Rev. per Employee

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