The Complaint alleges that throughout the class period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) Axsome’s chemistry, manufacturing, and control ("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) as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.