# AXS-12 (reboxetine) PDUFA Event: Cataplexy in narcolepsy

Canonical URL: https://biopharmsignal.com/pdufa-calendar/AXSM/axs-12-cataplexy-narcolepsy

Ticker: AXSM

Company: Axsome

Event date: 2027-05-01

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA set May 1, 2027 as the PDUFA target action date for Axsome's AXS-12 NDA and said it did not then plan to hold an advisory committe...

## Event Timeline

### May 1, 2027 — FDA decision expected

FDA set May 1, 2027 as the PDUFA target action date for Axsome's AXS-12 NDA and said it did not then plan to hold an advisory committee meeting.

[Axsome — NDA acceptance and PDUFA date](https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/axsm-ex99_1.htm)

### July 15, 2026 — FDA accepted the NDA for review

FDA accepted the AXS-12 NDA for the treatment of cataplexy in narcolepsy.

[Axsome — FDA acceptance announcement](https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/axsm-ex99_1.htm)

### July 15, 2026 — Phase 3 clinical evidence supported the filing

Axsome's NDA submission was supported by its completed clinical development program for AXS-12 in patients with narcolepsy and cataplexy.

[Axsome — NDA filing support](https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/axsm-ex99_1.htm)

## Related Pages

- AXSM PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/AXSM.md

- AXSM company profile: https://biopharmsignal.com/company/AXSM.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-10-07 — Axsome Therapeutics to Report Third Quarter 2026 Financial Results on November 2: https://biopharmsignal.com/news/AXSM/axsome-therapeutics-to-report-third-quarter-2026-financial-results-on-november-2-54e70163.md

- 2026-09-21 — Axsome Therapeutics Announces Results of the Shared Goals Survey of Caregivers of Patients with Alzheimer’s Disease Agitation Presented at Psych Congress 2026 in Connection with World Alzheimer’s Day: https://biopharmsignal.com/news/AXSM/axsome-therapeutics-announces-results-of-the-shared-goals-survey-of-caregivers-o-44ffc5d4.md

- 2026-09-17 — Axsome Therapeutics Presents Ten Posters Exemplifying its Innovative Psychiatry and Neurology Portfolio at Psych Congress 2026: https://biopharmsignal.com/news/AXSM/axsome-therapeutics-presents-ten-posters-exemplifying-its-innovative-psychiatry--94ea946f.md

- 2026-09-02 — Axsome Therapeutics to Participate in Upcoming Investor Conferences: https://biopharmsignal.com/news/AXSM/axsome-therapeutics-to-participate-in-upcoming-investor-conferences-1bfc3461.md

- 2026-08-31 — Axsome Therapeutics Initiates SUMMIT Phase 3 Trial of AXS-05 in Smoking Cessation: https://biopharmsignal.com/news/AXSM/axsome-therapeutics-initiates-summit-phase-3-trial-of-axs-05-in-smoking-cessatio-1ac4cea8.md