AUVELITY® 1Q 2026 net product sales of $153.2 million, representing 59% year-over-year growth
SUNOSI® 1Q 2026 net product revenue of $33.9 million, representing 34% year-over-year growth
SYMBRAVO® 1Q 2026 net product sales of $4.1 million
AUVELITY approved for the treatment of agitation associated with dementia due to Alzheimer's disease
NDA for AXS-12 for the treatment of cataplexy in narcolepsy submitted to the FDA
AXS-20 (balipodect), potentially first-in-class, pre-Phase 3, PDE10A inhibitor for schizophrenia and Tourette syndrome, added to pipeline
Company to host conference call today at 8:00 AM Eastern
NEW YORK, May 04, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced financial results for the first quarter of 2026 and provided a general business update.
"Axsome had a tremendous start to 2026. Our commercial business delivered robust year-over-year growth in the first quarter, Auvelity was approved by the FDA as a first-in-class medicine for the treatment of agitation associated with dementia due to Alzheimer's disease, and we added a potentially first-in-class Phase 3-ready PDE10A inhibitor for schizophrenia and Tourette syndrome to our pipeline," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. "The approval of Auvelity for Alzheimer's disease agitation highlights our research and development productivity, and commitment to deliver innovation to patients living with serious brain health disorders. With three differentiated marketed medicines now approved for four highly prevalent CNS conditions, and an innovative pipeline which includes six potentially first-in-class and best-in-class product candidates targeting ten conditions with significant unmet medical need in psychiatry and neurology, Axsome is positioned to advance the frontiers of brain health for patients, and deliver substantial value for shareholders."
First Quarter 2026 Financial Highlights
Total net product revenue was $191.2 million for the first quarter of 2026, representing 57% year-over-year growth. Total net product revenue for the comparable period in 2025 was $121.5 million.
AUVELITY net product revenue was $153.2 million for the first quarter of 2026, representing 59% year-over-year growth. AUVELITY net product sales for the comparable period in 2025 were $96.2 million.
SUNOSI net product revenue was $33.9 million for the first quarter of 2026, representing 34% year-over-year growth, which consisted of $32.6 million in net product sales and $1.3 million in royalty revenue associated with SUNOSI sales in out-licensed territories. SUNOSI net product revenue for the comparable period in 2025 was $25.2 million, which consisted of $24.1 million in net product sales and $1.1 million in royalty revenue.
SYMBRAVO net product revenue was $4.1 million for the first quarter of 2026.
Total cost of revenue was $14.7 million for the first quarter of 2026. Total cost of revenue for the comparable period in 2025 was $9.8 million.
Research and development (R&D) expenses were $52.7 million for the first quarter of 2026, compared to $44.8 million for the comparable period in 2025. The increase primarily reflects a one-time acquisition-related expense.
Selling, general, and administrative (SG&A) expenses were $185.0 million for the first quarter of 2026, compared to $120.8 million for the comparable period in 2025. The increase primarily reflects the acceleration of pre-launch activities for AUVELITY for the Alzheimer's disease agitation indication and commercialization activities for AUVELITY, including direct-to-consumer advertising, and commercialization activities for SYMBRAVO.
Net loss for the first quarter of 2026 was $64.5 million, or $(1.26) per share, compared to a net loss of $59.4 million, or $(1.22) per share, for the comparable period in 2025. The net loss in the first quarter of 2026 includes $23.4 million in stock-based compensation expense.
Cash and cash equivalents totaled $305.1 million at March 31, 2026, compared to $322.9 million at December 31, 2025.
Shares of common stock outstanding were 51,420,445 at March 31, 2026.
Financial Guidance
Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan.
Commercial Highlights
AUVELITY
AUVELITY is a first‑in‑class oral NMDA receptor antagonist and sigma‑1 receptor agonist approved in the U.S. for the treatment of major depressive disorder in adults, and for the treatment of agitation associated with dementia due to Alzheimer's disease.
Approximately 223,000 prescriptions were written for AUVELITY in the first quarter of 2026, a 35% increase compared to the first quarter of 2025, with prescriptions consistent with the fourth quarter of 2025.
Payer coverage for AUVELITY across all channels is currently at approximately 86% of all lives. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are approximately 78% and 100%, respectively.
In April 2026, the U.S. Food and Drug Administration (FDA) approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer's disease. AUVELITY is a first-in-class pharmacotherapy that targets the NMDA and sigma-1 receptors, which are thought to modulate key neurotransmitters implicated in Alzheimer's disease. The commercial launch of AUVELITY in Alzheimer's disease agitation is on track for June 2026.
The recently announced expansion of the AUVELITY sales force is substantially complete. Our expanded sales team of approximately 630 sales representatives will engage a broad group of prescribers, including primary care providers, psychiatrists, neurologists, and geriatric specialists, leveraging strong and growing demand in MDD and the substantial opportunity in Alzheimer's disease agitation.
SUNOSI
SUNOSI is the first and only DNRI approved for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea or narcolepsy.
Approximately 54,000 prescriptions were written for SUNOSI in the U.S. in the first quarter of 2026, representing an increase of 16% compared to the same period in 2025, with prescriptions consistent with the fourth quarter of 2025.
Payer coverage for SUNOSI across all channels is approximately 83% of all covered lives. The proportion of lives covered in the commercial and government channels are approximately 96% and 60%, respectively.
SYMBRAVO
SYMBRAVO is an oral, rapidly absorbed, multi-mechanistic, COX-2 preferential inhibitor and 5-HT1B/1D agonist approved in the U.S. for the acute treatment of migraine with or without aura in adults.
Approximately 17,000 prescriptions were written for SYMBRAVO in the first quarter of 2026, representing a 36% increase compared to the fourth quarter of 2025.
Payer coverage for SYMBRAVO in the commercial channel expanded by 17 million new covered lives, effective May 2026. Overall payer coverage for SYMBRAVO across all channels is now at approximately 57% of all lives, with the proportion of covered lives in the commercial and government channels at approximately 56% and 57%, respectively.
Based on SYMBRAVO's growth since launch and increased demand, Axsome is expanding the SYMBRAVO sales force from 100 to 150 representatives. The expansion will support broader reach within the primary care market while deepening engagement with headache specialists and neurologists nationwide.
Development Pipeline
Axsome is advancing an industry-leading neuroscience pipeline of multiple, innovative, late-stage, product candidates addressing a broad range of serious psychiatric and neurological conditions. Recent and anticipated progress for key pipeline programs is summarized below.
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome's novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor being developed for smoking cessation.
Smoking Cessation: Axsome is on track to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in the second quarter of 2026.
Solriamfetol
Solriamfetol is Axsome's dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with EDS symptoms, binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD).
Attention Deficit Hyperactivity Disorder: Axsome is on track to initiate two pediatric Phase 3 trials of solriamfetol in ADHD, one in children and one in adolescents, in the second quarter of 2026.
Major Depressive Disorder: In February 2026, Axsome initiated the CLARITY study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of solriamfetol for the treatment of MDD with EDS symptoms. The primary endpoint is the time from randomization into the double-blind treatment period to relapse of depressive symptoms.
Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in BED. The Company anticipates topline results from the ENGAGE Phase 3 trial in the second half of 2026.
Shift Work Disorder: Axsome is conducting the SUSTAIN study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol in SWD in adults. The Company anticipates topline results from the SUSTAIN Phase 3 trial in 2027.
AXS-12
AXS-12 (reboxetine) is Axsome's novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy.
Narcolepsy: Axsome has submitted an NDA to the FDA for AXS-12 for the treatment of cataplexy in narcolepsy. The Company plans to announce the FDA's decision on acceptance of the filing.
AXS-14
AXS-14 (esreboxetine) is Axsome's novel, oral, investigational, highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine.
Fibromyalgia: Axsome is conducting the FORWARD study, a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial evaluating the efficacy and safety of AXS-14 for the management of fibromyalgia.
AXS-17
AXS-17 is Axsome's novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM) being developed for the treatment of epilepsy.
Epilepsy: Phase 2 trial-enabling activities for AXS-17 in epilepsy are underway.
AXS-20
AXS-20 (balipodect) is Axsome's novel oral, potent, and selective phosphodiesterase 10A (PDE10A) inhibitor being developed for the treatment of schizophrenia and Tourette syndrome. The Company acquired balipodect in April 2026.
Schizophrenia: Phase 3 trial-enabling activities for AXS-20 in schizophrenia are anticipated in 2026.
Tourette Syndrome: Axsome plans to evaluate AXS-20 as a potential treatment for Tourette syndrome.
Anticipated Milestones
Regulatory and Commercial:
AUVELITY for Alzheimer's disease agitation, full commercial launch (June 2026)
Clinical Trial Topline Results:
Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2H 2026)
Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2027)
Clinical Trial Initiations and Progress:
Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2Q 2026)
Phase 3 trial of solriamfetol in children with ADHD, initiation (2Q 2026)
Phase 3 trial of solriamfetol in adolescents with ADHD, initiation (2Q 2026)
Conference Call Information
Axsome will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss its first quarter 2026 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at axsome.com. A replay of the conference call will be available for approximately 30 days following the live event.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. ...
