Axsome Therapeutics Inc., AXSM, FDA Calendar, PDUFA Date

Company Name	Axsome Therapeutics, Inc. AXSM
Drug Name	AXS-05
Event Name	FDA decision on AXS-05 for the treatment of Alzheimers disease agitation
Event Date	04/30/2026
Outcome Date	04/30/2026
Outcome	FDA approved AXS-05, under the brand name AUVELITY, for agitation associated with dementia due to Alzheimer’s disease on Apr.30, 2026
Drug Status	Priority Review
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