Karimian v. Alkermes Public Limited Company et al 1:18-cv-07410-LDH-SMG — On December 27, 2018, investors sued Alkermes Public Limited Company (“Alkermes” or the “Company”) in United States District Court, Eastern District of New York. The ALKS class action alleges that plaintiffs acquired Alkermes stock at artificially inflated prices between February 17, 2017 and November 1, 2018 (the “Class Period”). They are now seeking compensation for financial losses incurred upon public revelation of the Company’s alleged misconduct during that time. For more information on the ALKS Lawsuit, please contact us today!

Summary of the Allegations

Company Background

Incorporated in Ireland, Alkermes (NASDAQ: ALKS) is a biopharmaceutical company engaged in the research, development and marketing of pharmaceutical products.

According to its website, the Company “is uniquely positioned to be an engine of innovative treatments for major clinical conditions specifically focused on central nervous system (CNS) disorders.” These maladies include schizophrenia, depression, addiction and multiple sclerosis.

The Company’s U.S. facilities are located in Waltham, Massachusetts and Wilmington, Ohio.

Summary of Facts

Alkermes and two of its senior officers and/or directors (the “Individual Defendants”) are now accused of deceiving investors by lying and withholding critical information about the Company’s business practices during the Class Period.

Specifically, they are accused of omitting truthful information about the Company’s compliance with certain FDA directives from SEC filings and related material. By knowingly or recklessly doing so, they allegedly caused Alkermes stock to trade at artificially inflated prices during the time in question.

The truth came out in a series of events that transpired between April 2, 2018 and November 1, 2018. First, the Company disclosed that it had received a “Refusal to File” letter from the FDA in connection with one of its products known as ALKS 5461. Then, on October 30, 2018, the FDA released a “briefing document,” in which it indicated that it “did not agree with Alkermes’ methodologies and that Alkermes disregarded the FDA’s advice.”

Finally, Alkermes announced, “that the FDA advisory committee voted 21 to 2 against the approval of ALKS 5461.” On the same day, November 1, 2018, 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 did.”

A closer look…

As alleged in the December 27 complaint, the Company and/or Individual Defendants repeatedly made false and misleading public statements during the Class Period.

For instance, on a form filed with the SEC at the beginning of the Class Period, Alkermes said in pertinent part: “Based on the results of FORWARD-5, the supportive evidence from FORWARD-4 and the successful phase 2 study of ALKS 5461, we recently met with the FDA’s Division of Psychiatric Products at a Type C meeting to discuss ALKS 5461. We will request a pre-NDA meeting with the FDA and plan to submit the New Drug Application (‘NDA’) for ALKS 5461 in the second half of 2017.”

Then, on January 31, 2018, the Company announced its submission of an NDA that would allow ALKS 5461 to be used in the treatment of major depressive disorder (“MDD”). In that context, Alkermes said in pertinent part: “Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile o antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.”

Finally, on another form filed with the SEC on July 26, 2018, the Company stated in relevant part: “Our NDA for ALKS 5461 was submitted to the FDA in January 2018 and accepted by the FDA for review in April 2018. Acceptance of the NDA for review followed FDA issuance, and then rescission, of a refusal to file letter citing insufficient evidence of effectiveness and the need for additional bridging data, both of which we expect will be addressed in the context of the FDA’s review. The NDA is based on a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD.”

Impact of the Alleged Fraud on Alkermes Stock Price and Market Capitalization

The following chart illustrates the stock price during the class period:

Actions You May Take

If you have purchased shares during the Class Period, you may join the class action as a lead plaintiff, remain a passive class member, or opt out of this litigation and pursue individual claims that may not be available to the class as a whole.

NOTE: The deadline to file for lead plaintiff in this class action is February 25, 2019. You must file an application to be appointed lead plaintiff prior to this deadline in order to be considered by the Court. Typically, the plaintiff or plaintiffs with the largest losses are appointed lead plaintiff.

In order to identify your potential exposure to the alleged fraud during the time in question, you may wish to perform an analysis of your transactions in Alkermes common stock using court approved loss calculation methods.

Recently Filed Cases

Listed below are recently filed securities class action cases being monitored by us, along with the class period and the deadline to file a motion to be appointed as the Lead Plaintiff in the action.

Please contact us if you would like an LK report for any of these cases:

About Us

Levi & Korsinsky is a leading securities litigation firm with a hard-earned reputation for protecting investors’ rights and recovering losses arising from fraud, mismanagement and corporate abuse.  With thirty attorneys and offices in New York, Connecticut, California and Washington D.C., the firm is able to litigate cases in various jurisdictions in the U.S., England, and in other international jurisdictions.

Levi & Korsinsky provides portfolio monitoring services for high-net worth investors and institutional clients.  Our firm also assists investors in evaluating whether to opt-out of large securities class actions to pursue individual claims.

For additional information about this case or our institutional services, please contact us.