February 26, 2024


Equality opinion

AXSOME ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Axsome Therapeutics, Inc. and Encourages Investors to

NEW YORK–(Business enterprise WIRE)–#Motion–Bragar Eagel & Squire, P.C., a nationally identified stockholder rights regulation firm, announces that a class action lawsuit has been filed towards Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) in the United States District Court docket for the Southern District of New York on behalf of all people and entities who purchased or otherwise obtained Axsome securities between December 30, 2019 and April 22, 2022, equally dates inclusive (the “Class Period”). Buyers have right until July 12, 2022 to use to the Court to be appointed as lead plaintiff in the lawsuit.

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Axsome is a biopharmaceutical business that engages in the development of novel therapies for central nervous method disorders in the United States. The Firm is creating, among the other product or service candidates, AXS-07, a novel, oral, quickly absorbed, multi-mechanistic, and investigational drugs for the acute cure of migraine.

Axsome continuously touted AXS-07’s regulatory and commercial prospective customers in anticipation of the Company’s submission a New Drug Application (“NDA”) to the U.S. Foods and Drug Administration (“FDA”) for AXS-07 for the acute remedy of migraine (the “AXS-07 NDA”) primarily based on the drug’s optimistic success in two Period 3 trials. Nevertheless, unbeknownst to buyers, the Company’s preparing and eventual submission of the AXS-07 NDA was plagued with chemistry, producing, and management (“CMC”) issues.

The grievance alleges that, throughout the Course Time period, Defendants made materially untrue and deceptive statements pertaining to the Company’s enterprise, operations, and prospective customers. Exclusively, Defendants designed false and/or deceptive statements and/or unsuccessful to disclose that: (i) Axsome’s CMC tactics were being deficient with regard to AXS-07 and its manufacturing approach (ii) as a outcome, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline (iii) the foregoing CMC difficulties remained unresolved at the time that the Food and drug administration reviewed the AXS-07 NDA (iv) accordingly, the Food and drug administration was not likely to approve the AXS-07 NDA (v) as a end result of all the foregoing, Axsome experienced overstated AXS-07’s regulatory and business prospects and (vi) as a consequence, the Company’s public statements have been materially wrong and misleading at all suitable occasions.

On November 5, 2020, Axsome issued a press launch reporting the Company’s 3rd quarter 2020 benefits. That press release disclosed that the Corporation “plans to submit the [AXS-07] NDA to the Fda in the first quarter of 2021, vs . earlier direction of the fourth quarter of 2020, to make it possible for for inclusion of supplemental producing info to be certain a robust submission package.”

On this information, Axsome’s stock price tag fell $5.22 per share, or 6.99%, to close at $69.51 for every share on November 5, 2020.

Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Trade Fee that, “[o]n April 22, 2022, Axsome . . . was informed by the [FDA] that [CMC] difficulties discovered through the FDA’s assessment of the Company’s [NDA] for its AXS-07 product or service candidate for the acute treatment method of migraine are unresolved.” That filing also disclosed that “[b]ased on the time remaining in the NDA critique cycle, the Firm expects to receive a Entire Response Letter [(‘CRL’)] with respect to this NDA on or about the Prescription Drug User Charge Act target action day of April 30, 2022.”

On this information, Axsome’s stock price fell $8.60 for each share, or 21.99%, to near at $30.50 per share on April 25, 2022.

Last but not least, on May 2, 2022, Axsome announced that it acquired a CRL from the Fda regarding the AXS-07 NDA for the acute treatment method of migraine. In accordance to the Company, “[t]he principal reasons given in the CRL relate to [CMC] considerations” which includes “the want for further CMC info pertaining to the drug products and producing process.”

If you purchased or usually obtained Axsome shares and suffered a decline, are a prolonged-phrase stockholder, have details, would like to study far more about these statements, or have any questions about this announcement or your legal rights or pursuits with respect to these matters, make sure you get in touch with Brandon Walker or Melissa Fortunato by electronic mail at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this get hold of type. There is no price tag or obligation to you.

About Bragar Eagel & Squire, P.C.:

Bragar Eagel & Squire, P.C. is a nationally regarded regulation firm with workplaces in New York, California, and South Carolina. The organization signifies particular person and institutional investors in business, securities, by-product, and other intricate litigation in point out and federal courts throughout the region. For much more info about the agency, be sure to take a look at www.bespc.com. Legal professional advertising. Prior results do not ensure equivalent outcomes.


Bragar Eagel & Squire, P.C.

Brandon Walker, Esq.

Melissa Fortunato, Esq.

(212) 355-4648