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

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

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.”

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 Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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