Robbins Geller Rudman & Dowd LLP announces that purchasers of Axsome Therapeutics, Inc. (NASDAQ: AXSM) securities between December 30, 2019 and April 22, 2022, inclusive (the “Class Period”) have until July 12, 2022 to seek appointment as lead plaintiff in Gru v. Axsome Therapeutics, Inc., No. 22-cv-03925 (S.D.N.Y.). The Axsome class action lawsuit charges Axsome and certain of its top executive officers with violations of the Securities Exchange Act of 1934.
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CASE ALLEGATIONS: Axsome is developing, among other product candidates, AXS-07, a novel, oral, rapidly absorbed, multi-mechanistic, and investigational medicine for the acute treatment of migraine. Axsome consistently touted AXS-07’s regulatory and commercial prospects in anticipation of Axsome’s submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for AXS-07 for the acute treatment of migraine (the “AXS-07 NDA”) based on the drug’s positive results in two Phase 3 trials. However, as the Axsome class action lawsuit alleges, Axsome’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.
Specifically, the Axsome class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) Axsome’s CMC practices were deficient with respect to AXS-07 and its manufacturing process; (ii) as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline; (iii) the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA; (iv) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (v) thus, Axsome had overstated AXS-07’s regulatory and commercial prospects; and (vi) consequently, Axsome’s public statements were materially false and misleading at all relevant times.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Axsome securities during the Class Period to seek appointment as lead plaintiff. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.
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