New York-based biopharmaceutical company Axsome Therapeutics, Inc. (NASDAQ: AXSM) said on Wednesday that the US Food and Drug Administration has accepted for filing its supplemental New Drug Application for AXS-05 for Alzheimer's disease agitation and granted Priority Review.

The FDA has set a Prescription Drug User Fee Act target action date of April 30, 2026.

Priority Review shortens the FDA's review goal from ten months to six for medicines that may offer significant improvements for serious conditions.

The FDA previously granted Breakthrough Therapy designation to AXS-05 for Alzheimer's disease agitation in June 2020. The supplemental application follows a clinical programme comprising four randomised, double-blind, controlled Phase 3 trials and a long-term safety study.

AXS-05 combines dextromethorphan HBr and bupropion HCl and is approved in the United States for major depressive disorder, but is not yet approved by the FDA for Alzheimer's disease agitation.