Shareholder rights law firm Robbins LLP is investigating Axsome Therapeutics, Inc. (NASDAQ: AXSM) and its officers and directors to determine whether they breached their fiduciary duties and violated securities laws in connection with its New Drug Application for AXS-07 for the acute treatment of migraine. Axsome is a biopharmaceutical company that develops novel therapies for central nervous system ("CNS") disorders in the U.S.

If you would like more information about our investigation of Axsome Therapeutics, Inc.'s misconduct, click here.

What is this Case About: According to the complaint filed against Axsome, defendants touted AXS-07’s regulatory and commercial prospects in anticipation of the Company submitting 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.

On November 5, 2020, Axsome reported the Company’s third quarter 2020 results, disclosing 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 inclusion of supplemental manufacturing information to ensure a robust submission package.” On this news, Axsome’s stock price fell $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 an SEC filing that, “[o]n April 22, 2022, Axsome . . . was informed by the [FDA] that [CMC] issues identified during the FDA’s review of the Company’s [NDA] for its AXS-07 product candidate for the acute treatment of migraine are unresolved.” That filing also disclosed that “[b]ased upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter [(‘CRL’)] with respect to this NDA on or about the Prescription Drug User Fee Act [(‘PDUFA’)] target action date of April 30, 2022.” On this news, Axsome’s stock price fell $8.60 per share, or 21.99%, to close at $30.50 per share on April 25, 2022.

Finally, on May 2, 2022, Axsome announced that it received a CRL from the FDA regarding the AXS-07 NDA for the acute treatment of migraine. According to the Company, “[t]he principal reasons given in the CRL relate to [CMC] considerations” including “the need for additional CMC data pertaining to the drug product and manufacturing process.”

Next Steps: If you acquired shares of Axsome Therapeutics, Inc. (AXSM) between December 20, 2019 and April 22, 2022, you have legal options. Contact Robbins LLP for more information.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.

Contact us to learn more:

Aaron Dumas

(800) 350-6003

adumas@robbinsllp.com

Shareholder Information Form

About Robbins LLP: A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. To be notified if a class action against Axsome Therapeutics, Inc. settles or to receive free alerts when corporate executives engage in wrongdoing, sign up for Stock Watch today.

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