DETAILS OF THE CASE: According to the proposed Second Amended Complaint, defendants made false and/or misleading statements and/or failed to disclose that: (1) Axsome's chemistry, manufacturing, and control ("CMC") practices were deficient with respect to AXS-07 and its manufacturing process; (2) Axsome was unable to resolve these CMC problems or complete stability studies on additional batches of AXS-07 before it belatedly (after repeated delays in the initially represented timeline) submitted its AXS-07 New Drug Application ("NDA") in June 2021 ; (3) accordingly, the U.S. Food and Drug Administration was unlikely to approve the AXS-07 NDA; (4) as a result of all the foregoing, Axsome had overstated AXS-07's regulatory and commercial prospects; and (5) as a result, defendants' public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.