Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a fully integrated biopharmaceutical company that develops innovative medicines for central nervous system (CNS) conditions. The company focuses on identifying critical gaps in care and developing differentiated products with novel mechanisms of action to improve patient outcomes. Axsome's CNS portfolio includes three U.S. Food and Drug Administration (FDA) approved commercial products: AUVELITY for the treatment of major depressive disorder (MDD), SUNOSI for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea or narcolepsy, and SYMBRAVO for the acute treatment of migraine with or without aura in adults. Total revenues from these three commercial products reached $638.5 million for 2025, marking a 66% annual growth compared to 2024. Axsome is also developing a pipeline of novel product candidates. Its lead product candidate, AXS-05 (dextromethorphan and bupropion), is being developed for Alzheimer's disease (AD) agitation and smoking cessation. In December 2025, the FDA accepted the company's supplemental New Drug Application (sNDA) for AXS-05 for AD agitation, granting it Priority Review and setting a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. Solriamfetol is in Phase 3 clinical development for attention deficit hyperactivity disorder (ADHD), MDD with EDS symptoms, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). The company also has two novel, late-stage investigational products for narcolepsy and fibromyalgia, along with earlier-stage product candidates for CNS disorders, including AXS-17 for epilepsy. Axsome's strategy is to efficiently develop and commercialize novel, differentiated therapies for CNS disorders, focusing on indications with high unmet medical need.