Axsome Therapeutics, Inc. AXSM
Axsome Therapeutics, Inc. (Nasdaq: AXSM) is a CNS/neurology/psychiatry drug developer. Its lead program, AUVELITY (dextromethorphan-bupropion), is in Phase 3 for major depressive disorder. Its next catalyst on record is AXS-12: FDA action on NDA (PDUFA) (May 1, 2027).
Upcoming catalysts
- May 1, 2027AXS-12 — FDA action on NDA (PDUFA)
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| AUVELITY | MDD | small molecule | Approved |
| SUNOSI (solriamfetol) | EDS in narcolepsy/OSA | small molecule | Approved |
| SYMBRAVO | acute migraine | small molecule | Approved |
| AXS-12 (reboxetine) | cataplexy in narcolepsy | small molecule | Phase 3 |
| AXS-14 (esreboxetine) | fibromyalgia | small molecule | Phase 3 |
| AXS-05 | smoking cessation | small molecule | Phase 2 |
Recent results and decisions
- Jul 15, 2026accepted FDA accepted the AXS-12 NDA for cataplexy in narcolepsy; PDUFA date May 1, 2027, no advisory committee currently planned.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
Filing - Jul 1, 2026started Initiated the FOCUS-2 Phase 3 trial of solriamfetol in children with ADHD in July 2026.
In June and July 2026, Axsome initiated the FOCUS-3 and FOCUS-2 Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol as a treatment for adolescents and children with ADHD, respectively.
Filing - Jun 1, 2026started Initiated the FOCUS-3 Phase 3 trial of solriamfetol in adolescents with ADHD in June 2026.
In June and July 2026, Axsome initiated the FOCUS-3 and FOCUS-2 Phase 3, randomized, double-blind, placebo-controlled, multicenter trials evaluating the efficacy and safety of solriamfetol as a treatment for adolescents and children with ADHD, respectively.
Filing
6 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.