NEW YORK, Feb. 07, 2019 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Alkermes plc. (“Alkermes” or the “Company”) (NASDAQ: ALKS) and certain of its officers and directors.   The class action, filed in United States District Court, Eastern District of New York, and indexed under 19-cv-00624, is on behalf of a class consisting of all behalf of persons and/or entities who purchased or otherwise acquired Alkermes securities between February 17, 2017 through November 1, 2018, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. 

If you are a shareholder who purchased Alkermes securities between February 17, 2017, and November 1, 2018, you have until February 25, 2019, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

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Alkermes is incorporated in Ireland and is a biopharmaceutical company which researches, develops and commercializes pharmaceutical products.  

The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects.  Specifically, 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, the Company's 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 April 2, 2018, Alkermes reported that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461.  The Company stated that “the FDA has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461.”

On this news, shares in Alkermes’ stock fell $12.73 per share or nearly 22% to close at $45.23 per share on April 2, 2018.

On October 30, 2018, the FDA released a briefing document concerning Alkermes’ NDA for ALKS 5461.  The briefing document stated the FDA did not agree with Alkermes’ methodologies and that Alkermes disregarded the FDA’s advice.

On this news, shares in 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, Alkermes announced that the FDA advisory committee voted 21 to 2 against the approval of ALKS 5461. That same day, Xconomy reported that “[a]t the hearing, FDA representatives said the agency specifically told Alkermes not to analyze its data through an average, which it still did.”

On this news, shares in Alkermes’ stock fell $3.09 per share or over 7.5% to close at $37.74 per share on November 2, 2018, damaging investors.

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. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 9980