Rosen Law Firm, a global investor rights law firm, announces it is investigating potential securities claims on behalf of shareholders of Alkermes plc, Inc. (NASDAQ:ALKS) resulting from allegations that Alkermes may have issued materially misleading business information to the investing public.

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. The document revealed that 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.” The briefing document also revealed 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% 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. On this news, Alkermes’ stock fell $3.09 per share or over 7.5% to close at $37.74 per share on November 2, 2018.

Rosen Law Firm is preparing a class action lawsuit to recover losses suffered by Alkermes investors. If you purchased shares of Alkermes please visit the firm’s website at https://www.rosenlegal.com/cases-1452.html to join the class action. You may also contact Phillip Kim or Zachary Halper of Rosen Law Firm toll free at 866-767-3653 or via email at pkim@rosenlegal.com or zhalper@rosenlegal.com.

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Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013.

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The Rosen Law Firm, P.A.
Laurence Rosen, Esq.
Phillip Kim, Esq.
Zachary Halper, Esq.
275 Madison Avenue, 34^th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
zhalper@rosenlegal.com
www.rosenlegal.com

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