Axsome Therapeutics (AXSM)

Executive Summary

Axsome Therapeutics is a commercial-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders. The company has two approved products: Auvelity (AXS-05) for major depressive disorder and Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. Axsome's pipeline includes several late-stage candidates targeting large unmet needs. AXS-05 is being developed for agitation in Alzheimer's disease, with Phase 3 trials completed; a New Drug Application (NDA) submission is anticipated. AXS-07, a combination of meloxicam and rizatriptan, is under development for the acute treatment of migraine, with positive Phase 3 results. Additionally, solriamfetol is being investigated for major depressive disorder as an adjunctive therapy, with Phase 3 data recently read out. The company also has early-stage programs in fibromyalgia and other indications. With a strong commercial base and multiple value-driving catalysts, Axsome is well-positioned for near-term growth, though regulatory and commercial execution risks remain.

Upcoming Catalysts (preview)

• Q3 2026AXS-05 NDA submission for Alzheimer's disease agitation60% success
• Q4 2026AXS-07 NDA submission for acute migraine70% success
• Q2 2026Solriamfetol Phase 3 data for MDD adjunctive therapy and potential filing50% success