BP-205 — Topline data
Q4 2026
Topline data from the Phase 1 multiple ascending dose study is expected in the fourth quarter of 2026.Source filing
HRMY biotech catalysts & pipeline
HARMONY BIOSCIENCES HOLDINGS INC · Data as of 2026-09-08
Upcoming catalysts
BP-205 — Topline data
early 2027
In July 2026, we submitted an Investigational New Drug application ("IND") to the FDA, which is now open, and are preparing to initiate a Phase 1b study in sleep-deprived healthy volunteers in the third quarter of 2026, with topline data expected in early 2027.Source filing
EPX-100 (clemizole hydrochloride) — Topline data
1H 2027
Topline data expected in 1H 2027 and anticipated PDUFA dates in 2028Source filing
Pitolisant GR — PDUFA
Q1 2027
NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027Source filing
Pitolisant HD — Topline data
2027
Pitolisant HD On Track for Phase 3 Topline Data in 2027 and Target PDUFA Date in 2028Source filing
Pitolisant GR — PDUFA
Apr 1
Pitolisant GR NDA Accepted in July; Target PDUFA Date April 1, 2027Source filing
WAKIX (pitolisant) — Topline data
mid-2027
Topline data expected in mid-2027 and anticipated PDUFA date in 2028Source filing
EPX-100 (clemizole hydrochloride) — PDUFA
2028
Topline data expected in 1H 2027 and anticipated PDUFA dates in 2028Source filing
Pitolisant HD — PDUFA
2028
Pitolisant HD On Track for Phase 3 Topline Data in 2027 and Target PDUFA Date in 2028Source filing