NEW YORK, Jan. 8, 2019 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Alkermes plc ("Alkermes"or the "Company") (NASDAQ: ALKS). Such investors are advised to contact Robert S. Willoughby at email@example.com or 888-476-6529, ext. 9980.
The investigation concerns whether Alkermes and certain of
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On October 30, 2018, the U.S. Food and Drug Administration ("FDA") released a briefing document concerning the Company's New Drug Application ("NDA")for ALKS 5461 ahead of an FDA advisory committee meeting for the drug. The Company was developing ALKS 5461 as a treatment for major depressive disorder ("MDD"). The document disclosed that the Company "used an abridged 6-item version of the MADRS-10 for the primary endpoint of one of the principal studies" instead of a "10-item diagnostic questionnaire (MADRS-10)" despite the fact that FDA " explicitly [advised] against this plan." It was further 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, the Company's stock fell $0.57 per share or over 1.4% to close at $39.80 per share on October 30, 2018.
Then, on November 1, 2018, the FDA advisory committee voted 21 to 2 against the approval of ALKS 5461. At the hearing, FDA representatives reportedly stated that the agency told Alkermes not to analyze its data through an average, which Alkermes did anyway.
Following this news, Alkermes' stock fell $3.09 per share or over 7.5% to close at $37.74 per share on November 2, 2018.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
CONTACT:Robert S. WilloughbyPomerantz LLPrswilloughby@pomlaw.com
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SOURCE Pomerantz LLP
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