According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that:
- Axsome’s chemistry, manufacturing, and control (“CMC”) practices were deficient with respect to AXS-07 and its manufacturing process;
- 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 NDA in June 2021;
- 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.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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