Axsome Therapeutics Posts 66% Revenue Growth, Eyes Key Regulatory Milestones
Event summary
- Axsome Therapeutics reported $638.5M in full-year 2025 revenue, up 66% YoY, driven by AUVELITY and SUNOSI growth.
- AUVELITY sales surged 74% YoY to $507.1M, with 225K prescriptions in Q4 2025.
- sNDA for AXS-05 in Alzheimer’s disease agitation granted Priority Review with PDUFA target date of April 30, 2026.
- Acquired AXS-17, a novel oral GABAA α2,3 receptor positive allosteric modulator for epilepsy treatment.
- Plans to submit NDA for AXS-12 in narcolepsy in Q1 2026.
The big picture
Axsome Therapeutics is capitalizing on strong commercial momentum in its CNS portfolio, with AUVELITY and SUNOSI driving significant revenue growth. The company’s strategic focus on expanding its pipeline and securing regulatory approvals for AXS-05 and AXS-12 positions it to address high-unmet needs in neurology and psychiatry. Success in these areas could further solidify its leadership in the CNS therapeutic space.
What we're watching
- Regulatory Momentum
- Whether AXS-05 gains FDA approval for Alzheimer’s disease agitation by April 30, 2026, and its potential market impact.
- Pipeline Execution
- The pace at which Axsome advances solriamfetol trials in ADHD, MDD, and binge eating disorder.
- Commercial Expansion
- How the AUVELITY sales force expansion to 600 reps affects market penetration and prescription growth.
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