Axsome Revenue Rises 52% on SUNOSI Growth
The drugmaker reported third-quarter 2026 results and an FDA review of its AXS-12 application with a target action date of May 1, 2027.
Updated on Nov. 5, 2026 in Healthcare
Axsome Therapeutics reported total net product revenue of $259.7 million in the third quarter of 2026, up 52% year over year. SUNOSI net product revenue reached $48.2 million, a 47% increase from the same period in 2025.
Why it matters
The results show continued uptake of SUNOSI, a treatment for excessive daytime sleepiness tied to obstructive sleep apnea or narcolepsy, as Axsome advances its pipeline. The pending FDA review of AXS-12 for cataplexy in narcolepsy could add another product for patients with sleep disorders.
Axsome's SUNOSI revenue of $48.2 million rose 47% year over year, while payer coverage stands at about 82% of covered lives, including 97% of commercial lives and 59% of government lives. The extraction does not address how these figures will change once AXS-12 is commercially available.
The players
Axsome Therapeutics
Axsome Therapeutics is a U.S. biopharmaceutical company focused on central nervous system disorders, marketing SUNOSI and developing several pipeline candidates.
U.S. Food and Drug Administration
The U.S. Food and Drug Administration is the federal agency responsible for reviewing and approving new drug applications, including the pending AXS-12 application.
The details
Axsome said SUNOSI, a dopamine and norepinephrine reuptake inhibitor, continued to gain prescriptions in the US during the third quarter. The company also reported that a new drug application for AXS-12, an investigational norepinephrine reuptake inhibitor and cortical dopamine modulator, is under FDA review for cataplexy in narcolepsy.
Timeline
Q3 2026: Axsome reported revenue and SUNOSI prescription results.
First half of 2027: Expected completion of enrollment for the CLARITY trial of solriamfetol in major depressive disorder.
May 1, 2027: PDUFA target action date for AXS-12.
Second half of 2027: Anticipated topline results for the solriamfetol shift work disorder trial.
Healthcare Landscape
The AXS-12 application falls under the standard PDUFA review timeline that governs FDA decisions on new drug applications. Axsome's growth in SUNOSI sales reflects continued payer acceptance of treatments for sleep-related disorders in the U.S. market.
Patients with narcolepsy and sleep apnea-related sleepiness may eventually have another treatment option if AXS-12 is approved. Current SUNOSI users in the U.S. benefit from broader insurance coverage, with about 82% of covered lives reached.
The takeaway
Growth in both revenue and prescriptions suggests steady demand for SUNOSI, while the upcoming FDA decision on AXS-12 will show whether the company can expand its sleep disorder portfolio. Readers tracking treatments for narcolepsy should watch the May 1, 2027 action date.
What happens next
The FDA's target action date for AXS-12 is May 1, 2027, when the agency is expected to decide on the application for cataplexy in narcolepsy.
Further reading
Explore more on the Healthcare industry and how drugmakers are growing sales in the United States.
Source note: This article includes information reported by Sleep Review.
