Harmony Biosciences Holdings, Inc.
0 products tracked · names used in filings: Harmony Biosciences Holdings, Inc.
Upcoming milestones
Pitolisant GR: PDUFA target action date
Harmony Biosciences Holdings, Inc. (HRMY); pitolisant; NDA; status: set; "…nd Pharmacokinetic Profile Observed in Single-Ascending Dose Study Results from Phase 1b Study in Sleep-Deprived Healthy Volunteers for BP-205 Remain on Track for Q1 2027; Phase 2 Studies in Multiple CNS Indications Expected to Initiate by Mid-2027 Pitolisant GR NDA Under FDA Review, PDUFA Date April 1, 2027;…"; filed 2026-11-04 · source
Recent milestones
Harmony Biosciences Holdings, Inc.: PDUFA target action date
Harmony Biosciences Holdings, Inc. (HRMY); "Q4 & FY 2025 Financial Results & Business Update February 24, 2026 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995."; filed 2026-02-24 · source
Products
No products recorded.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.