Axsome gets FDA support for AXS-05 sNDA in Alzheimer's agitation; filing planned 3Q 2025

Axsome Therapeutics, Inc.

FDA pre-NDA meeting minutes confirm existing data package supports supplemental NDA submission for AXS-05.
Axsome plans to submit sNDA in third quarter 2025 for AXS-05 to treat Alzheimer's disease agitation.
AXS-05 previously granted FDA Breakthrough Therapy designation for Alzheimer's agitation in June 2020.
Three positive Phase 3 efficacy trials (ADVANCE-1, ACCORD-1, ACCORD-2) all met primary endpoint on CMAI.
No deaths in AXS-05 patients; no increased risk of falls, sedation, or cognitive decline in long-term data.

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