Alkermes Plc (NASDAQ: ALKS) Investor Securities Class Action Lawsuit 12/27/2018

If you purchased shares of Alkermes Plc (NASDAQ: ALKS), you have certain options and for certain investors are short and strict deadlines running. Deadline: February 25, 2019. NASDAQ: ALKS investors should contact the Shareholders Foundation, Inc.

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Company Name(s): 
Alkermes
Case Name: 
Alkermes Shareholder Class Action Lawsuit 12/27/2018
Case Status: 
Lawsuit Filed
Affected Securities
NASDAQ: ALKS
Lawsuit Overview
Type of Lawsuit: 
Shareholder Class Action
Date Filed: 
12/27/2018
Class Period Begin: 
02/17/2017
Class Period End: 
11/01/2018
Court of Filing: 
U.S. District Court for the Eastern District of New York
Deadline To File for Lead: 
02/25/2019
Summary: 

An investor in shares of Alkermes Plc (NASDAQ: ALKS) filed a lawsuit in the U.S. District Court for the Eastern District of New York over alleged violations of Federal Securities Laws by Alkermes Plc in connection with certain allegedly false and misleading statements made between. February 17, 2017 through November 1, 2018.

According to the complaint the plaintiff alleges on behalf of purchasers of Alkermes Plc (NASDAQ: ALKS) common shares between February 17, 2017 through November 1, 2018, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between February 17, 2017 through November 1, 2018, the , defendants made 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, that Alkermes had failed to follow that protocol, that consequently, an FDA advisory committee voted 21 to 2 against the approval of ALKS 5461; and that as a result, Alkermes’ public statements were materially false and/or misleading at all relevant times.

Ireland based Alkermes plc, a biopharmaceutical company, researches, develops, and commercializes pharmaceutical products to address unmet medical needs of patients in various therapeutic areas in the United States, Ireland, and internationally.

Alkermes Plc reported that its annual Total Revenue rose from $745.69 million in 2016 to $903.37 million in 2017 and that its Net Loss declined from $208.44 million in 2016 to $157.94 million in 2017.

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."

Shares of Alkermes Plc (NASDAQ: ALKS) declined from $71.22 per share in February 2018 to as low $32.77 per share on November 14, 2018.