Harmony Biosciences Holdings, Inc. HRMY
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) is a CNS/neurology/psychiatry drug developer. Its lead program, Pitolisant GR (gastro-resistant formulation), is in Phase 3 for Narcolepsy. Its next catalyst on record is Pitolisant GR: FDA PDUFA target action date (April 1, 2027).
Upcoming catalysts
- April 1, 2027Pitolisant GR — FDA PDUFA target action 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 1 MAD topline data (Q4 2026). 7 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Pitolisant GR | Narcolepsy | small molecule | Phase 3 |
| Pitolisant HD | Narcolepsy (ONSTRIDE1) and idiopathic hypersomnia (ONSTRIDE2) | small molecule | Phase 3 |
| EPX-100 (clemizole HCl) | Dravet syndrome (ARGUS) and Lennox-Gastaut syndrome (LIGHTHOUSE) | small molecule | Phase 3 |
| Pitolisant (WAKIX) new indication | Prader-Willi syndrome (TEMPO, Phase 3 registrational) | small molecule | Phase 3 |
| BP-205 (orexin-2 receptor agonist) | CNS indications outside sleep/wake; sleep-deprived healthy volunteers | small molecule | Phase 1 |
| CBS-104 | Refractory epilepsy | cell therapy | Pre-clinical |
| CBS-105 | Treatment-resistant narcolepsy | cell therapy | Pre-clinical |
| EPX-200 | Developmental and epileptic encephalopathies (pre-IND, per 10-K) | small molecule | Pre-clinical |
Recent results and decisions
- Jan 1, 2027n/a Peter Anastasiou appointed President and CEO effective January 1, 2027, succeeding retiring CEO Jeffrey Dayno.
Peter Anastasiou, former Harmony board member and current Sr. EVP and COO, to become President, Chief Executive Officer and a member of the Board, effective January 1, 2027.
Filing - Oct 12, 2026n/a Harmony Biosciences announces CEO transition with Peter Anastasiou replacing Jeffrey M. Dayno, M.D. effective January 1, 2027.
The Board of Directors has appointed Peter Anastasiou, former Harmony board member and current Sr. EVP and COO, to become President, Chief Executive Officer and a member of the Board, effective January 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.