Axsome Therapeutics (NASDAQ:AXSM) reported third-quarter revenue growth of 52% year over year, driven primarily by continued expansion of AUVELITY sales in major depressive disorder and Alzheimer’s disease agitation.
Total revenue reached $259.7 million in the quarter, up 19% sequentially and surpassing a $1 billion annualized run rate, Chief Executive Officer Herriot Tabuteau said. Net loss narrowed to $12.9 million, or $0.25 per share, from $47.2 million, or $0.94 per share, a year earlier.
“Our commercial portfolio generated $260 million in total revenue in the quarter,” Tabuteau said, adding that the company expects sustained momentum for AUVELITY, steady growth for SUNOSI, and increased trial and adoption of SYMBRAVO following an expansion of its sales team.
AUVELITY Drives Revenue Growth
AUVELITY net product sales totaled $207.6 million, increasing 53% from the prior-year quarter and more than 15% sequentially. Chief Financial Officer Nick Pizzie said the product’s sequential sales increases during the past two quarters were more than double its average quarterly increase before its label expansion for Alzheimer’s disease agitation.
SUNOSI generated $48.2 million in revenue, including $38.5 million in net product sales, $1.2 million in royalty revenue from out-licensed territories, and $8.5 million in milestone revenue tied to cumulative revenue outside the U.S. SYMBRAVO net product sales were $3.9 million, up 88% year over year.
Gross-to-net discounts improved for AUVELITY to the mid-to-high 40% range and for SUNOSI to the high 40% range. Pizzie said the company expects a slight increase in discounts during the fourth quarter due to normal seasonal dynamics. For 2027, he said Axsome expects AUVELITY’s gross-to-net profile to be similar to 2026.
Research and development expenses increased to $50.6 million from $40.2 million a year earlier, reflecting costs tied to late-stage programs for solriamfetol, AXS-14 and AXS-05. Selling, general and administrative expenses rose to $203.1 million from $150.2 million, primarily because of commercialization activities for AUVELITY and SYMBRAVO. However, SG&A was essentially flat sequentially as the initial field-force expansion became part of the company’s expense run rate.
Axsome ended the quarter with approximately $314 million in cash and cash equivalents, compared with $323 million at the end of 2025. Pizzie said the company expects its cash balance to fund operations through cash-flow positivity.
Prescription Growth Across Commercial Portfolio
Chief Commercial Officer Ari Maizel said AUVELITY total prescriptions reached approximately 302,000 in the third quarter, up 40% year over year and 14% sequentially. The broader antidepressant market grew 3% year over year and 2% sequentially, according to Axsome.
In patients age 65 and older, a cohort that primarily reflects use in Alzheimer’s disease agitation, AUVELITY new-to-brand prescriptions increased 211% year over year and 99% sequentially. Total prescriptions in that group rose 101% year over year and 43% sequentially.
For patients younger than 65, who primarily reflect major depressive disorder use, new-to-brand prescriptions increased 27% year over year and 10% sequentially, while total prescriptions rose 33% year over year and 10% sequentially.
Axsome activated about 8,200 new AUVELITY prescribers during the quarter, a 49% increase from the previous quarter, bringing the cumulative number of unique prescribers since launch to roughly 77,000. Primary care represented nearly 40% of prescribers and 25% of total prescriptions.
AUVELITY coverage remained at approximately 89% of total lives, including 82% of commercial lives and nearly all government-channel lives. Maizel said prescription abandonment is generally higher in Medicare than in commercial insurance, but the company has not observed unusual abandonment dynamics or significant Medicare Advantage disruptions.
SYMBRAVO surpassed 25,000 total prescriptions, growing 382% year over year and 7% sequentially. Its payer coverage was approximately 57% of covered lives. SUNOSI recorded more than 64,400 total prescriptions, up 15% year over year and 6% sequentially, with approximately 82% coverage across channels.
Pipeline Milestones Extend Into 2027
Axsome highlighted several expected clinical and regulatory milestones in 2027. The company began its SUMMIT Phase III study of AXS-05 for smoking cessation in August and expects top-line results in the second half of 2027.
- Top-line results from the ENGAGE Phase III trial of solriamfetol in binge eating disorder are expected in the first quarter of 2027.
- Results from pediatric Phase III ADHD studies FOCUS-2 and FOCUS-3 are anticipated in the second half of 2027.
- Results from the SUSTAIN Phase III trial in shift work disorder are expected in the second half of 2027.
- Enrollment in the CLARITY study of solriamfetol in major depressive disorder with excessive daytime sleepiness is expected to finish in the first half of 2027.
- Axsome plans to initiate a pivotal Phase III schizophrenia study of AXS-20 in the first half of 2027.
The FDA is reviewing Axsome’s application for AXS-12 in cataplexy associated with narcolepsy, with a target action date of May 1, 2027. Chief Operating Officer Mark Jacobson said the review is progressing as expected and that the FDA does not currently plan to hold an advisory committee meeting.
For AXS-14 in fibromyalgia, Axsome expects enrollment in the FORWARD Phase III study to finish in the third quarter of 2027. Tabuteau said that, if successful, the study could support an NDA submission alongside previously completed positive Phase II and Phase III trials. The company also plans to initiate clinical trials of AXS-17 in epilepsy during the first half of 2027.
Tabuteau said Axsome expects its commercial portfolio and late-stage neuroscience pipeline to support continued growth as it enters 2027.
About Axsome Therapeutics (NASDAQ:AXSM)
Axsome Therapeutics, Inc is a biopharmaceutical company focused on developing and commercializing therapies for central nervous system (CNS) disorders. Founded in 2012 and headquartered in New York, the company develops medicines for conditions with significant unmet medical needs, including depression, narcolepsy, excessive daytime sleepiness, and other neurological disorders.
Axsome’s commercial products include Auvelity (dextromethorphan and bupropion), an oral treatment approved in the United States for major depressive disorder in adults, and Sunosi (solriamfetol), a therapy for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.
