Shareholders with $500,000 losses or more are encouraged to contact the firm.

The Law Offices of Frank R. Cruz announces an investigation of Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) on behalf of investors concerning the Company’s possible violations of federal securities laws.

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On November 5, 2020, Axsome released its third quarter 2020 results, disclosing that the Company’s previous plan to submit a New Drug Application (“NDA”) for its migraine treatment AXS-07 in the fourth quarter of 2020 had been postponed to the first quarter of 2021 to “allow for inclusion of supplemental manufacturing information to ensure a robust submission package.”

On this news, Axsome’s stock fell $5.22, or 7%, to close at $69.51 per share on November 5, 2020, thereby injuring investors.

Then, on April 25, 2022, Axsome disclosed that the Company had been informed by the U.S. Food and Drug Administration (“FDA”) that chemistry, manufacturing, and control (”CMC”) issues “identified during the FDA’s review of the Company’s [NDA] for its AXS-07 product […] are unresolved.”

On this news, Axsome’s stock fell $8.60, or 22%, to close at $30.50 per share on April 25, 2022, thereby injuring investors further.

Then, on May 2, 2022, Axsome announced that it received a Complete Response Letter from the FDA, citing “the need for additional CMC date pertaining to the drug product and manufacturing process.”

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If you purchased Axsome securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to info@frankcruzlaw.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.

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