On March 13, 2019, Magistrate Judge Steven M. Gold of the United States District Court for the Eastern District of New York appointed Cohen Milstein Lead Counsel in this putative federal securities class action against Alkermes Public Limited Company (“Alkermes” or the “Company”) and certain directors and officers for alleged violations of the Securities Exchange Act of 1934.
Cohen Milstein represents Midwest Operating Engineers Pension Trust Fund, who the Court appointed as the lead plaintiff in the litigation.
On December 27, 2018, a putative federal securities class action complaint was filed on behalf of shareholders who purchased or otherwise acquired the publicly traded securities of Alkermes (NASDAQ: ALKS) during the Class Period, February 17, 2017 through November 1, 2018, both dates inclusive.
Alkermes is incorporated in Ireland and is a biopharmaceutical company which researches, develops and commercializes pharmaceutical products, including oral pharmaceutical treatments for major depressive disorders.
The complaint alleges that beginning in February 2017, when Alkermes filed its year-end Form 10-K for the fiscal year ended December 31, 2016, and continuing throughout the Class Period, Alkermes made a series of materially false and/or misleading statements about its new antidepressant drug, ALKS 5461, and pending New Drug Application (NDA) submission to and review by the U.S. Food and Drug Administration (FDA) in not only its SEC public disclosure documents, but also press releases and other public communications.
The complaint alleges that Defendants failed to disclose material adverse facts pertaining to the Company’s business, operational and financial results, which were known to the Defendants or recklessly disregarded by them. Specifically, the complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that the FDA had advised Alkermes to follow a certain protocol in connection with its NDA submission for ALKS 5461 and that Alkermes had failed to follow that protocol; consequently, an FDA advisory committee subsequently voted 21 to 2 against the approval of ALKS 5461.
The truth began to trickle out beginning in April 2018, when Alkermes reported that it received a Refusal to File letter from the FDA in March, in which the FDA noted that the NDA for ALKS 5461 provided insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials were needed prior to the Company’s resubmission of the NDA for ALKS 5461. On this news, shares in Alkermes plummeted by nearly 22%. Then, on October 30, 2018, the FDA released a briefing document on Alkermes’ NDA for ALKS 5461, stating that it did not agree with Alkermes’ methodologies and that Alkermes had disregarded the FDA’s advice. Upon this news, Alkermes stock slid an additional 1.4%.
Finally, on November 1, 2008, Alkermes announced that the FDA advisory committee voted 21 to 2 against the approval of ALKS 5461, stating at the hearing that “FDA representatives said the agency specifically told Alkermes not to analyze its data through an average, which it still did.” Alkermes stock dropped further, falling an additional $3.09 a share, or over 7.5% to close at $37.74 per share, further damaging class members.