Harmony Biosciences Holdings, Inc.

HRMY

$904M

Small Cap

NASDAQPharmaceutical Preparations🇺🇸North AmericaPLYMOUTH MEETING268 employees

Drugs in Pipeline

Phase 3 Programs

Upcoming Catalysts

Next Catalyst

May 19, 2026

14w

Data is aggregated from public sources (FDA, SEC, ClinicalTrials.gov). While we strive for accuracy, information may be incomplete, delayed, or contain errors. Terms apply

Market Overview

Stock performance and market intelligence

Catalyst Timeline

2 upcoming, 1 past

🎯PDUFANext

FDA PDUFA Date WAKIX (standard)

5/19/2026

For narcolepsy. sNDA filing. Extracted from SEC filing: 8-K

Source

⭐Phase 3

Pitolisant tablet Phase 3 Results Expected

July 2026~Pitolisant tablet134

Primary completion for Pitolisant tablet trial (NCT06366464) in Prader-Willi Syndrome

Source

AI Predictions & Institutional Flow

Machine learning insights and smart money movement

FDA Submissions

Pending NDA/BLA submissions with predicted PDUFA dates

Drug Pipeline

Clinical development programs and drug candidates

Drug Pipeline

Pitolisant tablet

Phase 3

Prader-Willi Syndrome

Pitolisant

Phase 3

Idiopathic Hypersomnia

Open-label pitolisant

Phase 3

Idiopathic Hypersomnia

Pitolisant Oral Tablet

Phase 2

Myotonic Dystrophy 1

Pitolisant oral tablets

Phase 2

Prader-Willi Syndrome

Drug Name	Phase	Indication	Designations
Pitolisant tablet	Phase 3	Prader-Willi Syndrome	-
Pitolisant	Phase 3	Idiopathic Hypersomnia	-
Open-label pitolisant	Phase 3	Idiopathic Hypersomnia	-
Pitolisant Oral Tablet	Phase 2	Myotonic Dystrophy 1	-
Pitolisant oral tablets	Phase 2	Prader-Willi Syndrome	-

Regulatory & News

Approvals, filings, and latest developments

Regulatory Approvals

HRMY News