Axsome AXS-05 succeeds in ACCORD-2 Phase 3 for Alzheimer's agitation; ADVANCE-2 misses primary endpoint

Axsome Therapeutics, Inc.

ACCORD-2 met primary endpoint: time to relapse delayed (HR=0.276, p=0.001); 3.6-fold lower relapse risk vs placebo.
ADVANCE-2 did not reach statistical significance on primary endpoint (CMAI change: -13.8 vs -12.6, p=NS); results numerically favored AXS-05.
No deaths, no increased falls, sedation, or cognitive decline in any trial; long-term safety in >300 patients for 6 months.
Three of four pivotal Phase 3 trials now positive; company plans NDA submission to FDA in second half 2025.
AXS-05 holds Breakthrough Therapy designation for Alzheimer's disease agitation since June 2020.

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