FDA Accepts Axsome's SNDA For AXS-05 In Alzheimer's Agitation With Priority Review

(RTTNews) - Axsome Therapeutics Inc. (AXSM) announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with Alzheimer's disease.

The FDA has granted the application Priority Review designation and set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.

Priority Review is reserved for medicines that, if approved, could deliver significant improvements in the treatment, diagnosis, or prevention of serious conditions compared to standard therapies. Under this designation, the FDA aims to review applications within six months, rather than the typical ten-month timeline.

AXS-05 had previously received Breakthrough Therapy designation from the FDA in June 2020 for the treatment of Alzheimer's disease agitation. This designation is intended to expedite development and review of promising investigational medicines when preliminary clinical evidence suggests substantial improvement over existing therapies for serious or life-threatening conditions.

The supplemental NDA submission reflects the culmination of Axsome's comprehensive clinical development program for AXS-05 in Alzheimer's disease agitation. This program included four randomized, double-blind, controlled Phase 3 clinical trials as well as a long-term safety study.

Axsome Therapeutics was trading at $150.00 in pre-market activity as of 7:09 AM EST, reflecting an increase of $1.21 or 0.81%.

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