NEW YORK, Dec. 31, 2018 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, announces that a securities class action lawsuit has been filed on behalf of those who purchased or acquired the securities of Alkermes plc (“Alkermes” or the “Company”) (NASDAQ: ALKS) between February 17, 2017 and November 1, 2018, both dates inclusive (the “Class Period”). The lawsuit seeks to recover Alkermes shareholders’ investment losses.
If you purchased Alkermes securities, and/or would like to discuss your legal rights and options, please visit Alkermes Shareholder Class Action Lawsuit or contact Daniel Sadeh toll free at (877) 779-1414 or dsadeh@bernlieb.com .
According to the lawsuit, throughout the Class Period Defendants made false and/or misleading statements and/or failed to disclose that: (1) the U.S. Food and Drug Administration (“FDA”) had advised Alkermes to follow a certain protocol in connection with its New Drug Application submission for ALKS 5461; (2) Alkermes had failed to follow that protocol; (3) consequently, an FDA advisory committee voted 21 to 2 against the approval of ALKS 5461; and (4) as a result, Alkermes’ public statements were materially false and/or misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
On October 30, 2018, the 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 wish to serve as lead plaintiff, you must move the Court no later than February 25, 2019. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
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-a...-stock-91/ or contact Daniel Sadeh toll free at (877) 779-1414 or dsadeh@bernlieb.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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Contact Information Daniel Sadeh Bernstein Liebhard LLP http://www.bernlieb.com (877) 779-1414 dsadeh@bernlieb.com
