Faruqi & Faruqi, LLP Encourages Investors Who Suffered Losses Exceeding $100,000 Investing In Alkermes plc To Contact The Firm
NEW YORK, January 25, 2019 / Globenewswire -- Faruqi & Faruqi, LLP, a leading national securities law firm, reminds investors in Alkermes plc ("Alkermes" or the "Company")(NASDAQ:ALKS) of the February 25, 2019 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
If you invested in Alkermes stock or options between February 17, 2017 and November 1, 2018 and would like to discuss your legal rights, please fill out the form below. There is no cost or obligation to you.
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The lawsuit has been filed in the U.S. District Court for the Eastern District of New York on behalf of all those who purchased Alkermes securities between February 17, 2017 and November 1, 2018 (the "Class Period"). The case, Karimian v. Alkermes Public Limited Company et al., No. 18-cv-07410 was filed on December 27, 2018, and has been assigned to Judge LaShann DeArcy Hall.
The lawsuit focuses on whether the Company and its executives violated federal securities laws by failing 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.
On April 2, 2018, Alkermes reported that it received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461. The Company stated that "the FDA has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461."
On this news, Alkermes's share price fell from $57.96 per share on March 29, 2018 to a closing price of $45.23 on April 2, 2018: a $12.73 or a 21.96% drop.
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.
On this news, Alkermes's share price fell from $40.37 per share on October 29, 2018 to a closing price of $39.80 on October 30, 2018: a $0.57 or a 1.41% drop.
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."
On this news, Alkermes's share price fell from $40.83 per share on November 1, 2018 to a closing price of $37.74 on November 2, 2018: a $3.09 or a 7.57% drop.
Alkermes plc (ALKS)
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Filed on 01/07/2019
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