San Diego, CA -- (SBWIRE) -- 05/23/2022 -- An investor, who purchased NASDAQ: AXSM shares, filed a lawsuit against Axsome Therapeutics, Inc. over alleged violations of Federal Securities Laws.

Investors who purchased shares of Axsome Therapeutics, Inc. (NASDAQ: AXSM) have certain options and for certain investors are short and strict deadlines running. Deadline: July 12, 2022. NASDAQ: AXSM investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

New York based Axsome Therapeutics, Inc., a biopharmaceutical company, engages in the development of novel therapies for central nervous system (CNS) 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.

The plaintiff says that Axsome Therapeutics, Inc 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 and that , 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 Therapeutics, Inc reported 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."

Then, on April 25, 2022, Axsome Therapeutics, Inc 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."

Finally, on May 2, 2022, Axsome Therapeutics, Inc 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."

Shares of Axsome Therapeutics, Inc. (NASDAQ: AXSM) declined from $47.40 per share on April 5, 2022, to as low as $24.13 per share on May 12, 2022.

The plaintiff claims that between December 30, 2019 and April 22, 2022, the defendants made false and/or misleading statements and/or failed to disclose that Axsome's CMC practices were deficient with respect to AXS-07 and its manufacturing process, that as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline, that the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA, that accordingly, the FDA was unlikely to approve the AXS-07 NDA, that as a result of all the foregoing, Axsome had overstated AXS-07's regulatory and commercial prospects, and that as a result, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of Axsome Therapeutics, Inc. (NASDAQ: AXSM) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About The Shareholders Foundation
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.