LOS ANGELES, Dec. 12, 2018 (GLOBE NEWSWIRE) -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Alkermes plc (“Alkermes” or “the Company”) (NASDAQ: ALKS) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.
The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. The FDA issued a briefing document about Alkermes’ new drug application for ALKS 5461 on October 30, 2018, in advance of an FDA advisory committee meeting about the drug. According to the briefing document, Alkermes “used an abridged 6-item version of the MADRS-10 for the primary endpoint of one of the principal studies” instead of the “10-item diagnostic questionnaire (MADRS-10)” despite the fact that the FDA provided “advice explicitly against this plan.” The document also stated that the FDA “disagreed with [Alkermes’] planned strategy to average the MADRS results over several weeks, and recommended use of the MADRS-10EOT, as used in other antidepressant studies and as previously agreed.” Based on this news, Alkermes’ stock price fell 1.4% on the same day.
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The class in this case has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.
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Brian Schall, Esq.
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