Company profile
HARMONY BIOSCIENCES HOLDINGS, INC.
NASDAQ:HRMYBiotechnology: Pharmaceutical Preparations
Drug pipeline (1)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| WAKIX | approved | $261.3MQ2 2026 | 0 | — |
Revenue is the latest quarter the company reported for that product, from SEC filings; a fourth quarter is the year less nine months when no filing states one. Trial counts are of the product's ingredients, deduplicated by trial, so products sharing an ingredient share trials.
Clinical trials (14)
| NCT ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT07860736 | phase1 | completed | 2026-06-18 | 2026-06-28 | Harmony Biosciences Management, Inc. | A Food Effect Study of Pitolisant Delayed-Release in Healthy Adult Participants |
| 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 |
FDA applications (1)
| Application | Approved | Type | Applicant | Products | ||||
|---|---|---|---|---|---|---|---|---|
| NDA 211150 | 2019-08-14 | NDA | HARMONY BIOSCIENCES MANAGEMENT INC | |||||
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