NEW YORK, Jan. 07, 2019 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a federal securities class action lawsuit has been filed in the United States District for the Eastern District of New York against Alkermes plc, Inc. ("Alkermes" or the "Company") (NASDAQ: ALKS) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Alkermes securities between February 17, 2017 and November 1, 2018, inclusive (the “Class Period”).
Investors who have incurred losses in the shares of a re urged to contact the firm immediately at classmember@whafh.com or (800) 575-0735 or (212) 545-4774. You may obtain additional information concerning the action on our website, www.whafh.com .
If you have incurred losses in the shares of Alkermes plc, Inc., you may, no later than February 25, 2019 , request that the Court appoint you lead plaintiff of the proposed class. Please contact Wolf Haldenstein to learn more about your rights as an investor in Alkermes plc, Inc.
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The filed Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements and/or failed to disclose that:
- 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;
- Alkermes had failed to follow that protocol;
- consequently, an FDA advisory committee voted 21 to 2 against the approval of ALKS 5461;
- and as a result, Alkermes’ public statements were materially false and/or misleading at all relevant times.
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.
Wolf Haldenstein Adler Freeman & Herz LLP has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.
If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735, via e-mail at classmember@whafh.com , or visit our website at www.whafh.com .
Contact:
Wolf Haldenstein Adler Freeman & Herz LLP Kevin Cooper, Esq. Gregory Stone, Director of Case and Financial Analysis Email: gstone@whafh.com , kcooper@whafh.com or classmember@whafh.com Tel: (800) 575-0735 or (212) 545-4774
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