Axsome Therapeutics AXSM

Axsome Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on developing innovative medicines for central nervous system conditions. The company identifies critical gaps in care and creates differentiated products with novel mechanisms of action that have the potential to transform patient outcomes. Its portfolio includes three FDA approved commercial products: AUVELITY for major depressive disorder, SUNOSI for excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy, and SYMBRAVO for the acute treatment of migraine with or without aura in adults. Beyond these marketed therapies, Axsome advances a deep pipeline of investigational candidates targeting serious neurological and psychiatric disorders.

Axsome generates revenue primarily from the sale of its three commercial products in the United States. In 2025 total revenues from AUVELITY, SUNOSI and SYMBRAVO reached $638.5 million reflecting a 66 percent increase compared with 2024. The company also earns royalties and milestone payments from licensing agreements but product sales constitute the core of its revenue stream.

The company operates through the following segments.

• Commercial Products: This segment includes AUVELITY which combines dextromethorphan and bupropion with metabolic inhibition technology to deliver NMDA receptor antagonism for major depressive disorder; SUNOSI which uses solriamfetol as a dopamine and norepinephrine reuptake inhibitor TAAR1 agonist and serotonin 1A agonist to treat excessive daytime sleepiness linked to obstructive sleep apnea or narcolepsy; and SYMBRAVO which employs MoSEIC technology to combine cyclooxygenase 2 inhibition with serotonin 1B/1D receptor agonism for the acute treatment of migraine with or without aura in adults. These products were launched between 2022 and 2025 and generated $638.5 million in sales in 2025.
• Development Programs: This segment encompasses the company’s pipeline of investigational candidates. AXS-05 is being studied for Alzheimer disease agitation and smoking cessation with a supplemental NDA accepted for filing in December 2025 and a PDUFA target action date of April 30 2026. Solriamfetol is in Phase 3 trials for attention deficit hyperactivity disorder major depressive disorder with excessive daytime sleepiness symptoms binge eating disorder and shift work disorder. AXS-12 (reboxetine) is a potent norepinephrine reuptake inhibitor under development for narcolepsy and has received pre NDA meeting support from the FDA. AXS-14 (esreboxetine) is a selective norepinephrine reuptake inhibitor being evaluated for fibromyalgia after an initial NDA refusal to file and a subsequent FORWARD study. AXS-17 (formerly AZD7325) is a GABA A receptor α2 3 positive allosteric modulator acquired for epilepsy treatment. These programs aim to address serious unmet medical needs in neurology and psychiatry.

Axsome holds a differentiated position in the central nervous system therapeutics landscape by leveraging proprietary medicinal chemistry and formulation technologies such as metabolic inhibition and the MoSEIC platform to create products with novel mechanisms of action. The company competes with large pharmaceutical firms including Johnson & Johnson Pfizer GSK AbbVie and specialty biotech firms such as Harmony Biosciences Jazz and Alkermes. Its competitive advantages stem from first in class or best in class profiles, rapid onset of action, and the ability to pursue regulatory efficiencies through the 505 b 2 pathway which can reduce development costs and time to market.

Axsome serves patients suffering from central nervous system disorders such as major depressive disorder excessive daytime sleepiness migraine Alzheimer disease agitation narcolepsy fibromyalgia and epilepsy. Its products are prescribed by physicians and distributed through pharmacies wholesalers and managed care organizations across the United States.