FDA Grants Priority Review to Axsome’s AXS-05 for Alzheimer’s Agitation With April 30, 2026 Decision Target

Overview

• The FDA accepted Axsome Therapeutics’ supplemental NDA for dextromethorphan-bupropion to treat agitation in Alzheimer’s disease.
• Priority Review sets a six‑month review goal versus the standard 10 months, with the PDUFA target action date on April 30, 2026.
• AXS-05 previously received Breakthrough Therapy designation for Alzheimer’s agitation in 2020.
• The drug is marketed as Auvelity for major depressive disorder in adults but is not approved for Alzheimer’s agitation.
• Axsome shares rose following the news, highlighting investor focus on a symptom reported in up to 76% of people with Alzheimer’s and with limited approved treatments.