Harmony Biosciences Holdings, Inc.HRMY
Neurology12 cited findings · profile updated 2026-08-25
38.95 USDnot live — refreshed daily
About Harmony Biosciences Holdings, Inc.
Harmony Biosciences Holdings, Inc. (HRMY) focuses on neurology. The company is advancing several drug candidates, including Pitolisant GR, Pitolisant HD, BP-205, and EPX-100. Pitolisant GR has an anticipated PDUFA date in Q1 2027, following an NDA submission in Q2 2026. Pitolisant HD is expected to have Phase 3 topline data in 2027, with a target PDUFA date in 2028.
BP-205 is undergoing early-stage development, with Phase 1 SAD/MAD clinical study data expected in mid-2026 in Europe. A US IND submission for BP-205 is also anticipated in mid-2026, with Phase 1b study initiation planned for 2H26. EPX-100, another candidate, demonstrated a median reduction in countable motor seizure frequency per 28 days (CMS-28) of approximately 50%, with at least a 50% reduction in CMS-28 observed. Phase 3 topline data for EPX-100 is expected in 1H 2027.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Anticipated PDUFA date | Q1 2027 for Pitolisant GR | Harmony Biosciences Holdings, Inc. — SEC 8-K (2026-05-07), p.6 |
| NDA submission | Q2 2026 for Pitolisant GR | Harmony Biosciences Holdings, Inc. — SEC 8-K (2026-05-07), p.6 |
| Phase 3 topline data | 2027 for Pitolisant HD | Harmony Biosciences Holdings, Inc. — SEC 8-K (2026-05-07), p.6 |
| Target PDUFA date | 2028 for Pitolisant HD | Harmony Biosciences Holdings, Inc. — SEC 8-K (2026-05-07), p.6 |
| Median reduction in countable motor seizure frequency per 28 days (CMS-28) | ~50% for EPX-100 | Harmony Biosciences Holdings, Inc. — SEC 8-K (2026-05-07), p.7 |
| Phase 3 topline data | 1H 2027 for EPX-100 | Harmony Biosciences Holdings, Inc. — SEC 8-K (2026-05-07), p.7 |
Key projects
- Pitolisant GR
An NDA submission for Pitolisant GR is planned for Q2 2026, with an anticipated PDUFA date in Q1 2027.
- Pitolisant HD
Phase 3 topline data for Pitolisant HD is expected in 2027, with a target PDUFA date in 2028.
- BP-205 — Europe
Phase 1 SAD/MAD clinical study data for BP-205 is expected in mid-2026 in Europe.
- EPX-100
EPX-100 showed a median reduction in countable motor seizure frequency per 28 days (CMS-28) of ~50%.
Every figure cites its source document. Prices refresh daily, not live. Informational only — not investment advice. Explore the Neurology research library →