Axsome Therapeutics (AXSM) catalysts

Upcoming FDA decisions and readouts we track for Axsome Therapeutics, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 11 Sep 2026

FreeBioList tracks 1 upcoming catalyst for Axsome Therapeutics (AXSM, listed on Nasdaq). It concerns AXS-12 (reboxetine) (Cataplexy in narcolepsy).

First on the list: the PDUFA date for AXS-12 (reboxetine) (Cataplexy in narcolepsy), dated 01 May 2027.

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 11 Sep 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: AXSM
Next catalyst: 01 May 2027
Type: PDUFA date
Listed options: Yes

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Axsome Therapeutics AXSM · Nasdaq	AXS-12 (reboxetine)	Cataplexy in narcolepsy	01 May 2027 in 206d	PDUFA date	Verified	8-K exhibit 99.1 ↗	Yes
Notes — Filing states the NDA "was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027." Source: 8-K exhibit 99.1, filed 10 Aug 2026 · verified 11 Sep 2026

Companies working on related conditions

Harmony Biosciences Holdings (HRMY)Narcolepsy

Also due in Q2 2027

Zenas BioPharma (ZBIO)PDUFA date for Obexelimab, 27 May 2027
Immunome (IMNM)PDUFA date for Varegacestat, 28 Apr 2027
Pharvaris N.V. (PHVS)PDUFA date for Deucrictibant IR, 23 Apr 2027
Context Therapeutics (CNTX)Phase 1 readout for CTIM-76, Q2 2027