Bragar Eagel & Squire, PC is investigating Axsome Therapeutics, Inc. on behalf of long-term shareholders and encourages investors to contact the company at

NEW YORK, April 30, 2024 (GLOBE NEWSWIRE) — Bragar Eagel & Squire, PC, a nationally recognized shareholder rights law firm, is investigating claims filed against Axsome Therapeutics, Inc. (NASDAQ: ) on behalf of long-term shareholders Potential claiming shareholders filed a class action lawsuit against Axsome on May 13, 2022, with a class action period from December 30, 2019 to April 22, 2022.

Axsome is a biopharmaceutical company engaged in the development of novel treatments for central nervous system diseases in the United States. The company is developing product candidates such as AXS-07, a novel oral, rapidly absorbed, multi-mechanism investigational drug for the acute treatment of migraine.

Axsome has continued to tout the regulatory and commercial prospects of AXS-07, and the company is expected to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AXS-07 for the treatment of acute migraine (AXS-07 NDA). Positive results for the drug in two phase 3 trials. However, what investors didn't know was that the company encountered chemistry, manufacturing and controls (CMC) issues during the preparation and final submission of the AXS-07 NDA.

The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements about 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 defective with respect to AXS-07 and its manufacturing process; (ii) Therefore, it was unlikely that Axsome submit the AXS-07 NDA within its originally stated timeline; (iii) the above CMC issues remain unresolved while FDA reviews the AXS-07 NDA; (iv) therefore, FDA is unlikely to approve the AXS-07 NDA; (v) ) For all of the foregoing reasons, Axsome overstated the regulatory and commercial prospects of AXS-07; (vi) As a result, the Company's public statements were materially false and misleading at all relevant times.

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On November 5, 2020, Axsome issued a press release reporting the company's third quarter 2020 results.A press release disclosed that the company plans to file [AXS-07] The NDA will be submitted to the FDA in the first quarter of 2021, compared to the previous guidance for the fourth quarter of 2020, to allow for the inclusion of supplemental manufacturing information to ensure a robust submission package.

Affected by this news, Axsome's stock price fell by $5.22 per share, or 6.99%, to close at $69.51 per share on November 5, 2020.

Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that [o]April 22, 2022 by Axsome. . .was informed [FDA] That [CMC] Issues the FDA discovered during its review of the company [NDA] Its AXS-07 product candidate for the treatment of acute migraine is unsolved.The document also revealed [b]Depending on the time remaining in the NDA review cycle, the Company expects to receive a complete response letter [(˜CRL’)] The Prescription Drug User Fee Act target action date on or about this NDA is April 30, 2022.

Affected by this news, Axsome's stock price fell by US$8.60 per share, or 21.99%, to close at US$30.50 per share on April 25, 2022.

Finally, Axsome announced on May 2, 2022 that it had received a CRL from the FDA for the AXS-07 NDA for the treatment of acute migraine. According to the company, [t]The main reasons given in the CRL relate to [CMC] Considerations include the need for additional CMC data related to drug products and manufacturing processes.

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If you are a long-term shareholder of Axsome, have information, would like to know more about these claims, or have any questions about this announcement or your rights or interests in relation to these matters, please contact Brandon Walker or Marion Passmore by email Email, call (212) 355-4648 or fill out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, PC:

Bragar Eagel & Squire, PC is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivatives and other complex litigation in state and federal courts across the country. For more information about the company, please visit Lawyer advertising. Previous results do not guarantee similar results.

Contact information:

Bragar Eagel & Squire, PC
Mr. Brandon Walker
Mr Marion Passmore

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