Harmony Biosciences Holdings (HRMY) catalysts

Upcoming FDA decisions and readouts we track for Harmony Biosciences Holdings, 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 Harmony Biosciences Holdings (HRMY, listed on Nasdaq). It concerns Pitolisant GR (Narcolepsy).

First on the list: the PDUFA date for Pitolisant GR (Narcolepsy), dated 01 Apr 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: HRMY
Next catalyst: 01 Apr 2027
Type: PDUFA date
Listed options: Yes

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Harmony Biosciences Holdings HRMY · Nasdaq	Pitolisant GR	Narcolepsy	01 Apr 2027 in 176d	PDUFA date	Verified	8-K exhibit 99.1 ↗	Yes
Notes — Filing states: "NDA accepted by FDA in July; target PDUFA date of April 1, 2027." The same filing flags further pitolisant PDUFA dates anticipated in 2028. Source: 8-K exhibit 99.1, filed 04 Aug 2026 · verified 11 Sep 2026

Companies working on related conditions

Axsome Therapeutics (AXSM)Cataplexy in narcolepsy

Also due in Q2 2027

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