NEW YORK, Aug. 10, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Axsome Therapeutics, Inc. (NASDAQ: AXSM) 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 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 a filing with the U.S. Securities and Exchange Commission 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 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.”

If you are a long-term stockholder of Axsome, have information, 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 Brandon Walker or Marion Passmore by email at investigations@bespc.com, by telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:

Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com