Axsome Q3 Revenue Rises 52% as AUVELITY Sales Reach $207.6 Million

Axsome Therapeutics reported third-quarter 2026 net product revenue of $259.7 million, up 52% from $171.0 million a year earlier, as growth in AUVELITY drove the neuroscience drugmaker’s annualized revenue run rate above $1 billion. The company also advanced several late-stage programs, with an FDA decision on AXS-12 for cataplexy in narcolepsy scheduled for May 1, 2027.

AUVELITY generated $207.6 million in quarterly net product revenue, a 53% year-over-year increase and about 80% of Axsome’s total. The drug’s growth reflected continued demand in major depressive disorder and early prescription gains following its April 30, 2026 FDA approval for agitation associated with dementia due to Alzheimer’s disease.

Total AUVELITY prescriptions reached approximately 302,000 during the quarter. New-to-brand prescriptions increased 21% sequentially, while the number of newly activated prescribers rose 19%. Axsome said about 77,000 clinicians had prescribed the treatment since launch and more than 400,000 patients had received it. Coverage stood at approximately 89% of total covered lives, including about 82% of commercial lives and nearly all Medicare and Medicaid covered lives.

Prescription trends strengthened among patients aged 65 and older after the Alzheimer’s disease agitation label expansion. Monthly prescriptions in that age group rose to 14,800 in September from 8,600 in April, while new-to-brand prescriptions increased to 3,600 from 1,200 over the same period. Prescriptions among patients under 65 also increased, reaching 88,200 in September.

SUNOSI contributed $48.2 million in net product revenue, including royalty and milestone revenue associated with out-licensed territories, up 47% from $32.8 million a year earlier. The excessive daytime sleepiness treatment recorded approximately 64,400 prescriptions during the quarter and had reached about 114,000 patients since launch. Axsome reported coverage of roughly 82% of total lives, including 97% of commercial lives and 59% of Medicare and Medicaid lives.

SYMBRAVO, Axsome’s acute migraine treatment, generated $3.9 million in third-quarter revenue, compared with $2.1 million a year earlier. Quarterly prescriptions exceeded 25,000, while approximately 24,900 patients and 5,750 prescribers had used the product since launch. Total payer coverage was about 57%.

Higher commercial and development spending accompanied the revenue growth. Selling, general and administrative expense increased 35% to $203.1 million, while research and development expense rose 26% to $50.6 million. Axsome did not provide quarterly earnings or cash-flow figures in the presentation.

As of September 30, the company held $313.9 million in cash and had $190 million of debt at face value. Management said the cash balance provides a runway to reach cash-flow positivity under its current operating plan, an expectation that depends on projected revenue and expenses.

Late-Stage Pipeline Milestones

Axsome said the FDA is reviewing its new drug application for AXS-12, or reboxetine, for cataplexy in narcolepsy. The application has a May 1, 2027 target action date. The company’s clinical data showed reductions in weekly cataplexy attacks, but the candidate remains subject to regulatory review.

The company also began the Phase 3 SUMMIT trial of AXS-05 for smoking cessation. The 12-week study compares AXS-05, bupropion and placebo, with topline results anticipated in the second half of 2027.

Enrollment has reached its target in the 450-patient Phase 3 ENGAGE trial of solriamfetol for binge eating disorder. Topline results are expected in the first quarter of 2027. Axsome is separately studying solriamfetol in children and adolescents with attention-deficit/hyperactivity disorder, adults with shift work disorder, and patients with major depressive disorder who have excessive daytime sleepiness symptoms.

Results from the pediatric ADHD FOCUS-2 and FOCUS-3 trials and the shift work disorder SUSTAIN trial are anticipated in the second half of 2027. Enrollment in the CLARITY trial for major depressive disorder with excessive daytime sleepiness is expected to be completed in the first half of 2027.

Beyond those programs, Axsome plans to initiate a Phase 3 trial of AXS-20 in schizophrenia and a Phase 1b study of AXS-17 in epilepsy during the first half of 2027. Enrollment in the Phase 3 FORWARD trial of AXS-14 for fibromyalgia is expected to be completed in the third quarter of 2027.

Axsome’s outlook remains subject to commercial, clinical and regulatory uncertainty. The company identified product adoption, payer coverage, gross-to-net sales, trial enrollment and costs, regulatory decisions, intellectual-property protection and its ability to fund development and commercialization as key risks. Its path to cash-flow positivity also assumes no material changes to currently projected revenue or expenses.