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;
- as a result, Axsome was unlikely to submit the AXS-07 New Drug Application (“NDA”) on its initially represented timeline;
- the foregoing CMC issues remained unresolved at the time that the U.S. Food and Drug Administration (“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.
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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