SHAREHOLDER ALERT: Alkermes plc (NASDAQ:ALKS)
(ShareholderAlert.com) — Shareholder Alert, a free shareholder news & information service announces that class actions have commenced on behalf of shareholders of Alkermes plc (NASDAQ: ALKS). If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. Shareholders interested in serving as lead plaintiff have until the deadlines listed to petition the court and further details about the cases can be found below.
Alkermes Public Limited Company (NASDAQ:ALKS)
Class Period: February 17, 2017 – November 1, 2018
Lead Plaintiff Deadline: February 25, 2019
According to the lawsuit, throughout the Class Period 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, Alkermes’ 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 October 30, 2018, the 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.”
On this news, Alkermes stock fell $0.57 per share, or over 1.4%, from its previous closing price to close at $39.80 per share on October 30, 2018, damaging investors.
Then, on November 1, 2018, the FDA advisory committee voted 21 to 2 against approval of ALKS 5461, and at the hearing, FDA representatives stated that the agency specifically told Alkermes not to analyze its data through an average, which it did anyways.
On this news, Alkermes stock fell $3.09 per share, or over 7.5%, from its previous closing price to close at $37.74 per share on November 2, 2018, damaging investors.