Axsome Therapeutics (NASDAQ: AXSM) is a biopharmaceutical company that develops and commercializes therapies for central nervous system (CNS) disorders. Revenue comes from product sales of its approved medicines, with AUVELITY (AXS-05, dextromethorphan-bupropion) approved for major depressive disorder, SUNOSI (solriamfetol) approved for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy, and SYMBRAVO (AXS-07, MoSEIC meloxicam-rizatriptan) approved by the FDA in January 2025 for migraine. Axsome retains U.S. commercial rights to these products and has licensed SUNOSI's European and certain Middle East and North Africa rights to Pharmanovia under a licensing agreement signed in February 2023. The company also generates pipeline value from late-stage candidates including AXS-05 for Alzheimer's disease agitation, which received FDA Priority Review with a PDUFA target action date of April 30, 2026, and solriamfetol in Phase 3 development for ADHD, MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder, per the FY2025 10-K filed February 23, 2026.

Revenue model

Axsome generates revenue primarily through U.S. product sales of AUVELITY, SUNOSI, and SYMBRAVO. Outside the U.S., the company monetizes SUNOSI through a licensing arrangement with Pharmanovia covering Europe and select Middle East and North Africa markets.

Products and services

Approved products as of the FY2025 10-K: AUVELITY (AXS-05, dextromethorphan-bupropion) for major depressive disorder; SUNOSI (solriamfetol) for excessive daytime sleepiness in obstructive sleep apnea and narcolepsy; SYMBRAVO (AXS-07, MoSEIC meloxicam-rizatriptan) for migraine, FDA-approved January 2025. Pipeline includes AXS-05 for Alzheimer's disease agitation (Priority Review, PDUFA April 30, 2026) and smoking cessation; solriamfetol in Phase 3 for ADHD, MDD with EDS, binge eating disorder, and shift work disorder; and AXS-17 in early development for epilepsy.

Customers and end markets

Patients and prescribing physicians treating CNS and neurological conditions in the U.S., including major depressive disorder, obstructive sleep apnea, narcolepsy, and migraine. Addressable populations cited in the filing include approximately 22 million U.S. adults with OSA, 185,000 with narcolepsy, and over 34 million adult cigarette smokers.

Value-chain role

Axsome is an integrated CNS drug developer and U.S. commercial-stage biopharmaceutical company. It conducts its own drug discovery using proprietary medicinal chemistry and formulation technologies, pursues FDA approval via both standard and 505(b)(2) regulatory pathways, and maintains its own U.S. commercial infrastructure. Ex-U.S. commercialization is conducted through licensing partners.

Geographic exposure

Primary commercial operations are in the United States. European and select Middle East and North Africa rights to SUNOSI are licensed to Pharmanovia. SK Biopharmaceuticals retains SUNOSI rights in 12 Asian markets including China, Korea, and Japan.

Source: SEC 10-K, filed 2026-02-23

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