Shareholders with $500,000 losses or more are encouraged to contact the firm.
Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Axsome Therapeutics, Inc. (“Axsome” or the “Company”) (NASDAQ: AXSM) securities between December 30, 2019 and April 22, 2022, inclusive (the “Class Period”). Axsome investors have until July 12, 2022 to file a lead plaintiff motion.
Investors suffering losses on their Axsome investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.
On November 5, 2020, Axsome released its third quarter 2020 results, disclosing that the Company’s previous plan to submit a New Drug Application (“NDA”) for its migraine treatment AXS-07 in the fourth quarter of 2020 had been postponed to the first quarter of 2021 to “allow for inclusion of supplemental manufacturing information to ensure a robust submission package.”
On this news, Axsome’s stock fell $5.22, or 7%, to close at $69.51 per share on November 5, 2020, thereby injuring investors.
Then, on April 25, 2022, Axsome disclosed that the Company had been informed by the U.S. Food and Drug Administration (“FDA”) that chemistry, manufacturing, and control (”CMC”) issues “identified during the FDA’s review of the Company’s [NDA] for its AXS-07 product […] are unresolved.”
On this news, Axsome’s stock fell $8.60, or 22%, to close at $30.50 per share on April 25, 2022, thereby injuring investors further.
Then, on May 2, 2022, Axsome announced that it received a Complete Response Letter from the FDA, citing “the need for additional CMC date pertaining to the drug product and manufacturing process.”
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Axsome’s CMC practices were deficient with respect to AXS-07 and its manufacturing process; (2) as a result, Axsome was unlikely to submit the AXS-07 NDA on its initially represented timeline; (3) the foregoing CMC issues remained unresolved at the time that the FDA reviewed the AXS-07 NDA; (4) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (5) as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and (6) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
If you purchased Axsome securities, have information or 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 Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.
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