Axsome Therapeutics FDA Approval for Alzheimer’s Agitation

Axsome Therapeutics shares jumped about 14% after the FDA approved AUVELITY for agitation in Alzheimer’s disease patients.
AUVELITY, already approved for major depressive disorder, received Breakthrough Therapy designation and Priority Review, marking its second neuropsychiatric indication.
Phase 3 ADVANCE‑1 and ACCORD‑2 trials showed statistically significant improvement in agitation scores and longer time to relapse versus placebo.
The drug has been administered to over 300,000 patients; a webcast on May 1 will detail the approval.