Did you lose money on investments in Axsome Therapeutics? If so, please visit Axsome Therapeutics, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or [email protected] to discuss your rights.
NEW YORK, May 16, 2022 /PRNewswire/ — Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) between December 30, 2019 and April 22, 2022, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the Southern District of New York and alleges violations of the Securities Exchange Act of 1934.
Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system (“CNS”) disorders in the U.S. 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 of 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 purported 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.
Plaintiff alleges that Defendants made materially false and misleading statements during the Class Period. Specifically, Plaintiff alleges 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) the FDA was unlikely to approve the AXS-07 NDA; and (v) as a result, Axsome had overstated AXS-07’s regulatory and commercial prospects.
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.
On April 25, 2022, during pre-market hours, 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.” The 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 over 21%, to close at $30.50 per share on April 25, 2022.
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 wish to serve as lead plaintiff, you must move the Court no later than July 12, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
If you purchased AXSM securities, and/or would like to discuss your legal rights and options please visit Axsome Therapeutics, Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or [email protected].
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.
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