Rosen Law Firm announces the reopening of the lead plaintiff appointment process in a class action lawsuit against Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) and certain of its officers. The Class Action, filed in the United States District Court for the Southern District of New York, and docketed under 22-cv-03925 (LGS), is proposed to be brought on behalf of a Class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Axsome common stock between May 10, 2021 and April 22, 2022, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”), and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. Excluded from the Class will be any persons who sold all of the shares acquired during the Class Period prior to April 25, 2022.

The Class Action was originally filed on May 13, 2022. On September 25, 2023, the Court issued an Opinion and Order in which it granted Defendants’ motion to dismiss the amended complaint and allowed Lead Plaintiff to seek leave to file a proposed Second Amended Complaint by October 13, 2023. Following Lead Plaintiff’s request to file a proposed Second Amended Complaint and the Defendants’ response thereto, on November 15, 2023 the Court ordered that the lead plaintiff appointment process be reopened and that notice be published.

If you are a shareholder who purchased or otherwise acquired Axsome common stock during the Class Period, you have until December 7, 2023 to ask the Court, by making a motion, to appoint you as Lead Plaintiff for the class. A copy of the proposed Second Amended Complaint can be obtained at https://rosenlegal.com/case/axsome-therapeutics-inc/. To discuss this action, contact Phillip Kim at pkim@rosenlegal.com or cases@rosenlegal.com or toll-free at 866-767-3653. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. To join the Axsome class action, go to https://rosenlegal.com/submit-form/?case_id=2221.

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 proposed Second Amended 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) Axsome was unable to resolve these CMC problems or complete stability studies on additional batches of AXS-07 before it belatedly (after repeated delays in the initially represented timeline) submitted its AXS-07 NDA in June 2021; (iii) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (iv) as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and (v) as a result, the Company’s public statements were materially false and misleading at all relevant times.

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.

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

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Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors.

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