Alkermes Plc (NASDAQ: ALKS) Investor Investigation Over Potential Securities Laws Violations Announced

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Company Name(s): 
Alkermes
Affected Securities: 
NASDAQ: ALKS

An investigation on behalf of investors of Alkermes Plc (NASDAQ: ALKS) shares over potential securities laws violations by Alkermes Plc and certain of its directors and officers in connection with certain financial statements was announced.

The investigation by a law firm focuses on 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.

Ireland based Alkermes plc, a biopharmaceutical company, researches, develops, and commercializes pharmaceutical products to address unmet medical needs of patients in various therapeutic areas in the United States, Ireland, and internationally.

Alkermes Plc reported that its annual Total Revenue rose from $745.69 million in 2016 to $903.37 million in 2017 and that its Net Loss declined from $208.44 million in 2016 to $157.94 million in 2017.

On October 30, 2018, the U.S. Food and Drug Administration ("FDA") released a briefing document on Alkermes' New Drug Application for ALKS 5461 ahead of a scheduled FDA advisory committee meeting for the drug. The FDA briefing document revealed that Alkermes "used an abridged 6-item version of the MADRS-10 for the primary endpoint of one of the principal studies (Study 207)" rather than the "10-item diagnostic questionnaire (MADRS-10) used to measure the severity of depressive episodes in patients with mood disorders," despite the FDA's "advice explicitly against this plan." Moreover, the FDA briefing 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."

Shares of Alkermes Plc (NASDAQ: ALKS) declined from $71.22 per share in February 2018 to as low $32.77 per share on November 14, 2018.