NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky announces it has commenced an investigation of Alkermes plc (“Alkermes” or “the Company”) (NASDAQGS:ALKS) concerning possible violations of federal securities laws.
On April 2, 2018, Alkermes announced receipt of a Refusal to File letter from the U.S. Food and Drug Administration regarding its New Drug Application for ALK 5461. According to Alkermes, the FDA determined 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.” Following this news, shares of Alkermes were down more 4% on intraday trading on April 3, 2018. To obtain additional information, go to:
or contact Joseph E. Levi, Esq. either via email at email@example.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972.
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