Axsome Crosses $1 Billion Run Rate as Quarterly Revenue Rises 52%

Axsome Therapeutics booked $259.7 million in third-quarter 2026 net product revenue, up 52% from $171.0 million a year earlier, putting the company on an annual run rate above $1 billion. The neuroscience developer also narrowed its net loss to $12.9 million, or $0.25 per share, from $47.2 million, or $0.94 per share, in the comparable 2025 quarter. Growth, it appears, has finally begun to arrive faster than the spending.

Chief Executive Officer Herriot Tabuteau, MD, said: "Axsome delivered 52% year-over-year total revenue growth in the third quarter, surpassing a one-billion-dollar annual run rate. We expect sustained momentum driven by strong underlying demand for Auvelity in major depressive disorder, and continued acceleration of new patient initiations in Alzheimer's disease agitation."

What drove the quarter?

AUVELITY, the company's oral NMDA receptor antagonist (a drug class acting on a brain signaling receptor) for major depressive disorder and Alzheimer's agitation, generated $207.6 million, up 53% from $136.1 million. SUNOSI contributed $48.2 million, up 47% from $32.8 million, including $8.5 million in milestone revenue and $1.2 million in royalties. SYMBRAVO, a migraine therapy, added $3.9 million, up 88% from $2.1 million.

Prescription volumes tell a consistent story:

• AUVELITY total prescriptions reached roughly 302,000, up 40% year over year and 14% sequentially; new patient starts rose 44% and 21%, respectively.
• Among patients aged 65 and older, AUVELITY new starts jumped 211% year over year, with total prescriptions up 101%.
• SUNOSI U.S. prescriptions totaled about 64,400, up 15% year over year.
• SYMBRAVO prescriptions hit approximately 25,000, up 382% year over year.

Payer coverage stands near 89% of all lives for AUVELITY, 82% for SUNOSI and 57% for SYMBRAVO.

Where did the money go?

Spending rose across every major line. Selling, general and administrative expenses climbed to $203.1 million from $150.2 million, reflecting AUVELITY and SYMBRAVO commercialization. Research and development expenses rose to $50.6 million from $40.2 million, driven by the solriamfetol, AXS-14 and AXS-05 clinical programs. Cost of revenue increased to $17.8 million from $11.9 million.

The balance sheet offers modest comfort. Cash totaled $313.9 million at September 30, down slightly from $322.9 million at year-end 2025, and Axsome believes current cash will fund operations into cash flow positivity under its existing plan. Shares outstanding stood at 52,576,839.

For the nine months, revenue rose to $669.3 million from $442.5 million, while the operating loss narrowed to $124.1 million from $139.8 million.

What comes next in the pipeline?

The development calendar is crowded, which explains the research bill. The SUMMIT Phase 3 trial of AXS-05 in smoking cessation began in August 2026, with results expected in the second half of 2027. The AXS-12 application for cataplexy in narcolepsy sits under FDA review, with a target action date of May 1, 2027.

Other anticipated milestones include:

• ENGAGE Phase 3 topline results in binge eating disorder, first quarter of 2027.
• SUSTAIN Phase 3 results in shift work disorder, second half of 2027.
• FOCUS-2 and FOCUS-3 Phase 3 results in pediatric and adolescent ADHD, second half of 2027.
• CLARITY Phase 3 enrollment completion in depression with excessive sleepiness, first half of 2027.
• FORWARD Phase 3 enrollment completion in fibromyalgia, third quarter of 2027.
• Phase 1B initiation for AXS-17 in epilepsy and pivotal Phase 3 initiation for AXS-20 in schizophrenia, both planned for the first half of 2027.

The company will discuss the results on a conference call at 8:00 a.m. Eastern Time. A $1 billion run rate and a $12.9 million loss: the gap between the two is now the whole investment case.