Axsome Therapeutics Inc (AXSM)

[georgejjl]

On April 22, 2022, Axsome Therapeutics, Inc. (the “Company”) was informed by the U.S. Food and Drug Administration (the “FDA”) that chemistry, manufacturing, and controls (“CMC”) issues identified during the FDA’s review of the Company’s New Drug Application (“NDA”) for its AXS-07 product candidate for the acute treatment of migraine are unresolved. Based upon the time remaining in the NDA review cycle, the Company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.

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