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Key takeaways:
- SUNOSI net product revenue reached $48.2 million in the third quarter of 2026, representing a 47% year-over-year growth.
- A new drug application for AXS-12, an investigational treatment for cataplexy in narcolepsy, is currently under FDA review with a target action date of May 1, 2027.
- Topline results for a phase 3 trial evaluating solriamfetol in adults with shift work disorder are anticipated in the second half of 2027.
Axsome Therapeutics Inc reported its financial results for the third quarter of 2026, noting a 52% year-over-year growth in total net product revenue, which reached $259.7 million. For sleep medicine professionals, the update highlighted continued commercial growth for its excessive daytime sleepiness therapy and clinical progress across its sleep-related development pipeline.
“Axsome delivered 52% year-over-year total revenue growth in the third quarter, surpassing a one-billion-dollar annual run rate,” says Herriot Tabuteau, MD, CEO of Axsome Therapeutics, in a release. “Our industry-leading neuroscience pipeline continued to advance, leading to multiple anticipated regulatory and clinical trial milestones in the coming quarters.”
SUNOSI, a dopamine and norepinephrine reuptake inhibitor approved for treating excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy, generated $48.2 million in net product revenue during the quarter. This represents a 47% increase compared to the same period in 2025.
Approximately 64,400 prescriptions were written for SUNOSI in the US in the third quarter, marking a 15% year-over-year increase and a 6% increase from the second quarter of 2026. Payer coverage for the drug currently stands at approximately 82% of all covered lives, including 97% of commercial lives and 59% of government lives.
The company also provided updates on its clinical pipeline targeting sleep disorders. Axsome’s new drug application (NDA) for AXS-12 (reboxetine), an investigational, highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator, is currently under review by the FDA for the treatment of cataplexy in narcolepsy. The Prescription Drug User Fee Act (PDUFA) target action date is set for May 1, 2027.
Additionally, Axsome is advancing clinical trials for new indications of solriamfetol:
- Shift Work Disorder: The company is conducting SUSTAIN, a phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of solriamfetol in adults with shift work disorder. Topline results are anticipated in the second half of 2027.
- Major Depressive Disorder: Enrollment for CLARITY, a phase 3 trial evaluating solriamfetol for major depressive disorder with excessive daytime sleepiness symptoms, is expected to be completed in the first half of 2027.
More in Narcolepsy Treatment Pipeline:
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