Alkermes investors may receive additional information about the case by clicking the link "Submit Your Information" above.
The Class Period commences on February 17, 2017, when Alkermes filed its Form 10-K for the fiscal year ended December 31, 2016 with the SEC, which provided Alkermes’ year-end financial results and position. The 2016 10-K further stated that Alkermes met with the U.S. Food and Drug Administration (“FDA”) in February 2017 prior to its New Drug Application (“NDA”) submission for ALKS 5461, a proprietary, once-daily, oral sublingual investigational medicine in development for the adjunctive treatment of Major Depressive Disorder.
According to the complaint, on April 2, 2018, Alkermes reported that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461. Following this news, shares in Alkermes’ stock fell $12.73 per share or nearly 22% to close at $43.23 per share on April 2, 2018.
Then, 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. Following 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.
Finally, 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.” Following 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.
The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (1) the FDA had advised Alkermes to follow a certain protocol in connection with its NDA 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.
If you are a member of the class described above, you may no later than February 25, 2019 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-888-299-7706 or 1-610-667-7706, or via e-mail at firstname.lastname@example.org. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.
Kessler Topaz Meltzer & Check, LLP
James Maro, Esq. or Adrienne Bell, Esq.
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Radnor, PA 19087
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