Thieler Law Corp, member of the Investor Attorney Network, is investigating whether certain officers and directors of Alkermes Plc (NASDAQ: ALKS) violated securities laws in connection with certain financial statements.
The investigation seeks to discover if possible claims on behalf of purchasers of the securities of Alkermes Plc (NASDAQ: ALKS) concerning whether a series of statements by Alkermes plc regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
On October 30, 2018, the U.S. Food and Drug Administration (“FDA”) released a briefing document concerning Alkermes’ New Drug Application for ALKS 5461 ahead of an FDA advisory committee meeting for 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” rather than the “10-item diagnostic questionnaire (MADRS-10)” despite the FDA’s “advice explicitly against this plan.” Furthermore, the document revealed 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.”
Following this news, NASDAQ: ALKS fell $0.57 per share or over 1.4% to close at $39.80 per share on October 30, 2018.
If you purchased shares of Alkermes Plc (NASDAQ: ALKS) on or before October 30, 2018, you should contact Thieler Law Corp at mail@thielerlaw.com or call +1 (619) 377 - 4324.
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