Axsome Therapeutics, Inc. AXSM
Axsome Therapeutics, Inc. (Nasdaq: AXSM) is a CNS/neurology/psychiatry drug developer. Its lead program, AXS-12 (reboxetine), is in Phase 3 for cataplexy in narcolepsy. Its next catalyst on record is AXS-12: PDUFA target action date (May 2027).
Upcoming catalysts
- May 2027AXS-12 — PDUFA target action date
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
Next further out: AXS-05 — SUMMIT trial ongoing (Phase 3 smoking cessation) (date not stated). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| AUVELITY (dextromethorphan-bupropion) | MDD in adults; agitation associated with dementia due to Alzheimer's disease | small molecule | Approved |
| SUNOSI (solriamfetol) | excessive daytime sleepiness in obstructive sleep apnea or narcolepsy | small molecule | Approved |
| SYMBRAVO (meloxicam-rizatriptan) | acute treatment of migraine with or without aura | small molecule | Approved |
| AXS-12 (reboxetine) | cataplexy in narcolepsy | small molecule | Phase 3 |
| solriamfetol | ADHD in children and adolescents (FOCUS-2, FOCUS-3) | small molecule | Phase 3 |
| solriamfetol | MDD with EDS symptoms (CLARITY study) | small molecule | Phase 3 |
| solriamfetol | binge eating disorder (ENGAGE) | small molecule | Phase 3 |
| solriamfetol | excessive sleepiness associated with shift work disorder (SUSTAIN) | small molecule | Phase 3 |
| AXS-05 (dextromethorphan-bupropion) | smoking cessation | small molecule | Phase 3 |
| AXS-14 (esreboxetine) | fibromyalgia | small molecule | Phase 3 |
| AXS-20 | schizophrenia and Tourette syndrome (planned evaluation) | small molecule | Phase 2 |
| AXS-17 | epilepsy (planned evaluation) | small molecule | Pre-clinical |
Recent results and decisions
- Nov 2, 2026completed enrollment Target enrollment reached in the ENGAGE Phase 3 trial of solriamfetol in binge eating disorder, with topline results anticipated in 1Q 2027.
Target enrollment in the trial has been reached, and the Company anticipates topline results in the first quarter of 2027.
Filing - Sep 30, 2026completed enrollment ENGAGE Phase 3 trial of solriamfetol in binge eating disorder has reached target enrollment.
Target enrollment in the trial has been reached.
Filing - Aug 1, 2026started Axsome initiated the SUMMIT Phase 3 trial of AXS-05 for smoking cessation in August 2026.
In August 2026, Axsome initiated the SUMMIT study, a Phase 3, randomized, double-blind, active- and placebo-controlled, multicenter trial to assess the efficacy and safety of AXS-05 for the treatment of smoking cessation.
Filing
10 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.