Company profile
Harmony Biosciences Holdings, Inc.
NASDAQ:HRMYBiotechnology: Pharmaceutical Preparations
Drug pipeline (1)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| PITOLISANT HYDROCHLORIDE | approved | — | 0 | — |
Revenue is the latest reported period from SEC filings. A combination product's amount appears on each of its constituent assets, so those rows are not additive.
Clinical trials (12)
| NCT ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT05458128 | phase3 | completed | 2022-08-19 | 2025-10-01 | Harmony Biosciences Management, Inc. | A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia |
| NCT04257929 | phase2 | completed | 2020-12-09 | 2022-08-17 | Harmony Biosciences Management, Inc. | A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension |
| NCT07500090 | phase3 | recruiting | 2026-03-16 | 2027-10-01 | Harmony Biosciences Management, Inc. | A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) |
| NCT07675135 | phase3 | recruiting | 2026-06-04 | 2027-10-01 | Harmony Biosciences Management, Inc. | A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy |
| NCT05156047 | phase3 | completed | 2022-05-25 | 2023-09-08 | Harmony Biosciences Management, Inc. | A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia |
FDA applications (1)
| Application | Type | Applicant | Products | |||
|---|---|---|---|---|---|---|
| NDA 211150 | NDA | HARMONY BIOSCIENCES MANAGEMENT INC | ||||
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