Harmony Biosciences Holdings, Inc.
HRMYDrugs in Pipeline
7
Phase 3 Programs
4
Upcoming Catalysts
2
Next Catalyst
Jul 15, 2026
8wMarket Overview
Stock performance and key metrics
3 upcoming, 1 past
FDA PDUFA Date WAKIX (standard)
For narcolepsy. sNDA filing. Extracted from SEC filing: 8-K
FDA approved supplemental new drug application (sNDA) for Wakix (pitolisant) tablets for treatment of cataplexy in pediatric narcolepsy
Source2 more catalysts beyond 14 days
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Pitolisant
Idiopathic Hypersomnia
Pitolisant tablet
Prader-Willi Syndrome
Open-label pitolisant
Idiopathic Hypersomnia
HBS-301 tablet
Idiopathic Hypersomnia
Pitolisant Oral Tablet
Myotonic Dystrophy 1
Pitolisant oral tablets
Prader-Willi Syndrome
ZYN002
22Q11.2 Deletion Syndrome
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Pitolisant | Phase 3 | Idiopathic Hypersomnia | - | - |
Pitolisant tablet | Phase 3 | Prader-Willi Syndrome | - | - |
Open-label pitolisant | Phase 3 | Idiopathic Hypersomnia | - | - |
HBS-301 tablet | Phase 3 | Idiopathic Hypersomnia | - | - |
Pitolisant Oral Tablet | Phase 2 | Myotonic Dystrophy 1 | - | - |
Pitolisant oral tablets | Phase 2 | Prader-Willi Syndrome | - | - |
ZYN002 | Phase 2 | 22Q11.2 Deletion Syndrome | - | - |