PRNewswire 9-Nov-2018 11:10 AM
NEW YORK, Nov. 9, 2018 /PRNewswire/ -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, is investigating potential securities fraud claims on behalf of shareholders of Alkermes plc ("Alkermes" or the "Company") (NASDAQ:ALKS) resulting from allegations that Alkermes and/or its executives may have issued materially misleading business information to the investing public.
If you purchased Alkermes securities, and/or would like to discuss your legal rights and options, please visit Alkermes Shareholder Investigation or contact Daniel Sadeh toll free at (877) 779-1414 or firstname.lastname@example.org.
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."
On this news, Alkermes stock fell $0.57 per share, or over 1.4%, from its previous closing price to close at $39.80 per share on October 30, 2018, damaging investors.
Then, on November 1, 2018, the FDA advisory committee voted 21 to 2 against approval of ALKS 5461, and at the hearing, FDA representatives stated that the agency specifically told Alkermes not to analyze its data through an average, which it did anyways.
On this news, Alkermes stock fell $3.09 per share, or over 7.5%, from its previous closing price to close at $37.74 per share on November 2, 2018, damaging investors.
If you purchased Alkermes securities, and/or would like to discuss your legal rights and options, please visit https://www.bernlieb.com/cases/alkermes-plc-alks-lawsuit-class-action-fraud-stock-91/ or contact Daniel Sadeh toll free at (877) 779-1414 or email@example.com.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal's "Plaintiffs' Hot List" thirteen times and listed in The Legal 500 for ten consecutive years.
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SOURCE Bernstein Liebhard LLP
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