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Axsome Therapeutics announces FDA acceptance of NDA resubmission for AXS-07

Axsome Therapeutics announces FDA acceptance of NDA resubmission for AXS-07

Axsome Therapeutics announced that the U.S. Food and Drug Administration, FDA, has acknowledged the resubmission of the Company’s New Drug Application, NDA, for AXS-07 for the acute treatment of migraine. The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act, PDUFA, action goal date of January 31, 2025.

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