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Axsome Therapeutics, Inc.

Company NameAxsome Therapeutics, Inc.
Stock SymbolAXSM
Class PeriodDecember 30, 2019 to April 22, 2022
Lead Plaintiff Motion DeadlineJuly 12, 2022

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.

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