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Case Status:    ONGOING    
On or around 03/11/2024 (Date of last review)

Filing Date: May 13, 2022

According to the Complaint, Axsome Therapeutics, Inc. is a biopharmaceutical company that engages in the development of novel therapies for CNS disorders in the U.S. The Company is developing, among other product candidates, AXS-07, a novel, oral, rapidly absorbed, multi-mechanistic, and investigational medicine for the acute treatment of migraine.

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.

On August 11, 2022, the Court issued an Order appointing Co-Lead Plaintiffs and Counsel. Co-Lead Plaintiffs filed an amended Complaint on October 7. Defendants filed a Motion to Dismiss the amended Complaint on December 16.

On September 25, 2023, the Court issued an Order granting Defendants' Motion to Dismiss. Plaintiffs were given leave to seek to file another amended Complaint.

On November 9, 2023, the Court reopened the Lead Plaintiff appointment process. On January 22, 2024, the Court issued an Order appointing Lead Plaintiffs and Co-Lead Counsel. Lead Plaintiffs filed a second amended Complaint on February 7.

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