Alkermes Public Limited Company (NASDAQ: ALKS)
Hagens Berman Sobol Shapiro LLP alerts investors in Alkermes Public Limited Company (NASDAQ: ALKS) to the February 25, 2019 Lead Plaintiff deadline in the securities class action pending in the U.S. District Court for the Eastern District of New York.
If you purchased or otherwise acquired shares of ALKS between February 1, 2017 and November 1, 2018 and suffered losses contact Hagens Berman Sobol Shapiro LLP. For more information, contact Reed Kathrein, who is leading the firm's investigation, by calling 510-725-3000 or emailing ALKS@hbsslaw.com.
The complaint alleges Defendants knew, throughout the class period, that the U.S Food and Drug Administration disagreed with Alkermes’ clinical trial methodologies in connection with a New Drug Application (“NDA”) for approval of a drug (ALKS 5461) intended to treat Major Depressive Disorder.
On November 1, 2018, Defendants announced the FDA advisory committee voted 21 to 2 against the approval of ALKS 5461. Separately, the press reported Alkermes did not follow the FDA’s previously-expressed guidance for the NDA.
This news drove the price of Alkermes shares down $3.09, or over 7.5% to close at $37.74 on November 2, 2018.
Most recently, on February 1, 2019, the Company and senior management announced the FDA informed them that it would not approve the ALKS 5461 NDA and requested additional clinical data to provide substantial evidence of the drug’s effectiveness.
“Right now, our focus is on investors’ losses and the extent to which Defendants may have misled them,” said Hagens Berman partner Reed Kathrein.
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