Thursday, 18 April 2024

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Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm By

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NEW YORK, April 03, 2024 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Axsome Therapeutics, Inc. (NASDAQ: NASDAQ:) on behalf of long-term stockholders following a class action complaint that was filed against Axsome on May 13, 2022 with a Class Period from December 30, 2019 to April 22, 2022. Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.

Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States.  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.

Axsome consistently touted AXS-07’s regulatory and commercial prospects in anticipation of the Company’s submission a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AXS-07 for the acute treatment of migraine (the AXS-07 NDA) based on the drug’s positive results in two Phase 3 trials.  However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (CMC) issues.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Axsome’s 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 November 5, 2020, Axsome issued a press release reporting the Company’s third quarter 2020 results.  That press release disclosed that the Company plans to submit the [AXS-07] NDA to the FDA in the first quarter of 2021, versus previous guidance of the fourth quarter of 2020, to allow for…

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