A class action lawsuit has been filed in the USDC, S.D.N.Y. against Axsome Therapeutics, Inc. (“AXSM”), on behalf of all persons and entities who purchased or otherwise acquired Axsome Therapeutics, Inc. (“Axsome” or the “Company”) securities between December 30, 2019 and April 22, 2022 (the “Class Period”).
The Complaint alleges that, throughout the Class Period, defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that:
- Axsome’s CMC practices were deficient with respect to AXS-07 and its manufacturing process;
- as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline;
- the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA;
- accordingly, the FDA was unlikely to approve the AXS-07 NDA;
- as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and
- as a result, the Company’s public statements were materially false and misleading at all relevant times.
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