Harmony Biosciences Holdings Inc Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
5-Yr Fwd EPS Growth
21.3%projected annual EPS growth
Analyst Coverage
10analysts covering
FY Revenue (est.)
$1Bnext fiscal year
FY EPS (est.)
$5.22next fiscal year
Reporting Calendar
| Event | Expected Date |
|---|---|
| Q3 2026 Earnings Release | 3 Nov 2026 |
Monitoring Framework
Key Performance Indicators
WAKIX Net Product Revenue Quarterly215.4MTarget: 1000000000 to 1040000000
Average Number of Patients on WAKIX Quarterly8.5KTarget: Continued sequential growth
Watch Items
- Pitolisant GR (Gastro-Resistant) NDA Submission and FDA ReviewTrigger: NDA submission planned for Q2 2026; anticipated PDUFA date in Q1 2027Action: Monitor regulatory filings and FDA acceptance of the NDA to ensure lifecycle extension into the 2040s remains on track.
- Pitolisant HD (High-Dose) Phase 3 Registral Trials (ONSTRIDE 1 & 2)Trigger: Topline data readouts expected in 2027; anticipated PDUFA date in 2028Action: Track patient enrollment and clinical milestones for narcolepsy and idiopathic hypersomnia indications.
- Pitolisant in Prader-Willi Syndrome (PWS) Phase 3 TrialTrigger: Topline Phase 3 data readout expected in 2H 2026Action: Evaluate clinical efficacy and safety data to secure pediatric exclusivity (additional 6 months of regulatory exclusivity).
Research as of 20 Jun 2026