Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) is a fully integrated biopharmaceutical company focused on developing innovative medicines for central nervous system disorders. The company operates through a portfolio of FDA-approved commercial products and an extensive pipeline of novel product candidates in early- to late-stage development. Axsome's website is www.axsome.com.

The company's commercial portfolio consists of three FDA-approved products generating significant revenue. AUVELITY, approved in August 2022, is an oral N-methyl-D-aspartate receptor antagonist for major depressive disorder in adults, representing the first and only oral antidepressant with rapid-acting efficacy reflected in the FDA label. SUNOSI, a dopamine and norepinephrine reuptake inhibitor acquired from Jazz Pharmaceuticals, treats excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy. SYMBRAVO, approved in January 2025, is a multi-mechanistic selective COX-2 inhibitor and serotonin receptor agonist for acute migraine treatment. Combined, these three products generated $638.5 million in revenue during 2025, representing 66 percent annual growth.

Axsome's development pipeline includes several late-stage candidates addressing significant unmet medical needs. AXS-05 is being developed for Alzheimer's disease agitation and smoking cessation, with an FDA supplemental application for AD agitation accepted in December 2025 with Priority Review designation. Solriamfetol is in Phase 3 development for attention deficit hyperactivity disorder, major depressive disorder with excessive daytime sleepiness, binge eating disorder, and shift work disorder. AXS-12, a norepinephrine reuptake inhibitor, is in late-stage development for narcolepsy cataplexy. AXS-14 is being evaluated for fibromyalgia management, and AXS-17, recently acquired from AstraZeneca, targets epilepsy treatment.

The company leverages proprietary medicinal chemistry and formulation technologies, including chiral chemistry, metabolic inhibition, and the MoSEIC technology platform designed to enhance drug solubility and absorption. Axsome maintains commercial infrastructure in the United States while pursuing strategic partnerships for international markets. The company's intellectual property portfolio includes more than 600 issued patents and 450 pending applications worldwide, with patent protection extending through 2045 for certain products.