Overview
- Priority Review shortens the FDA’s target review timeline to six months rather than the roughly ten months of a standard review.
- AXS-05 previously received Breakthrough Therapy designation for Alzheimer’s agitation in 2020.
- AXS-05, marketed as Auvelity for major depressive disorder, is not approved for Alzheimer’s agitation.
- Shares of Axsome rose about 18% to a new 52-week high following the regulatory update, according to Benzinga.
- Separately, Axsome says it received formal pre-NDA meeting minutes for AXS-12 in narcolepsy and expects to complete that NDA submission in January 2026.