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Axsome Therapeutics announces FDA acceptance, priority review of AXS-05 sNDA

Axsome Therapeutics (AXSM) announced that the U.S. Food and Drug Administration has accepted for filing the Company’s supplemental New Drug Application for AXS-05 for the treatment of Alzheimer’s disease agitation, and has granted the application Priority Review designation. The FDA has set a Prescription Drug User Fee Act target action date of April 30, 2026.

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