Axsome Therapeutics, Inc.
PDUFA Confirmed
AXS-05
Alzheimer’s disease agitation
Resolved
68days ago
FDA decision · Apr 30, 2026
What's at stake The FDA's approval decision on AXS-05 for Alzheimer’s disease agitation is due Apr 30, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
“sNDA for AXS-05 for the treatment of Alzheimer’s disease agitation was accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action da”

Provenance

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