Harmony Biosciences Holdings, Inc. HRMY
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) is a CNS/neurology/psychiatry drug developer. Its lead program, Pitolisant GR, is in Phase 3 for Narcolepsy (EDS and cataplexy). Its next catalyst on record is Pitolisant GR: PDUFA target date (April 2027).
Upcoming catalysts
- April 2027Pitolisant GR — PDUFA target date
In June 2026, we submitted a New Drug Application ("NDA") for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act ("PDUFA") date of April 1, 2027.
Next further out: BP-205 — Phase 1b topline data (Q1 2027). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Pitolisant GR | Narcolepsy (EDS and cataplexy) | small molecule | Phase 3 |
| Pitolisant HD | Narcolepsy fatigue and IH sleep inertia | small molecule | Phase 3 |
| EPX-100 (clemizole) | Dravet syndrome and Lennox-Gastaut syndrome | small molecule | Phase 3 |
| Pitolisant | Prader-Willi Syndrome (EDS) | small molecule | Phase 3 |
| BP-205 | Multiple CNS indications (unspecified) | small molecule | Phase 1 |
| Pitolisant amorphous | Broad CNS indications outside sleep/wake | small molecule | Pre-clinical |
| CBS-104 | Refractory epilepsy | cell therapy | Pre-clinical |
| CBS-105 | Treatment-resistant narcolepsy | cell therapy | Pre-clinical |
Recent results and decisions
- Nov 4, 2026positive BP-205 multiple-ascending dose Phase 1 study showed favorable safety, tolerability and PK profile after 14 days of once-daily dosing with no liver or visual adverse events.
Repeated Once-Daily Dosing with BP-205 in Multiple-Ascending Dose Study Reinforces Favorable Safety, Tolerability and Pharmacokinetic Profile Observed in Single-Ascending Dose Study
Filing - Nov 4, 2026accepted Pitolisant GR NDA accepted by FDA with PDUFA date of April 1, 2027.
NDA accepted by the FDA with PDUFA date of April 1, 2027
Filing - Aug 4, 2026positive Phase 1 SAD: Tmax 30-75 minutes, mean half-life ~25h supporting once-daily dosing, dose-proportional exposure, no serious or severe TEAEs.
Generally safe and well tolerated with no serious or severe TEAEs
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.