---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-004860"
form_type: "8-K"
ticker: "HRMY"
cik: "0001802665"
company_name: "Harmony Biosciences Holdings, Inc."
filed_at: "2023-03-29T23:59:59+00:00"
generated_at: "2026-06-17T10:48:49.773290+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Harmony Biosciences accelerates Phase 3 INTUNE enrollment; topline data expected Q4 2023

## Summary
- Enrollment completion expected Q2 2023, just over one year from trial initiation.
- Topline data anticipated in Q4 2023.
- Pre-specified interim sample size analysis allowed study to continue with original planned sample size.
- Phase 3 INTUNE study: double-blind, placebo-controlled, randomized withdrawal in ~200 IH patients at ~60 U.S. sites.
- Pitolisant (WAKIX) is approved for narcolepsy but not yet for idiopathic hypersomnia.

## SEC filing metadata
- accession: 0001558370-23-004860
- form_type: 8-K
- ticker: HRMY
- cik: 0001802665
- company_name: Harmony Biosciences Holdings, Inc.
- filed_at: 2023-03-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1802665/000155837023004860/0001558370-23-004860-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1802665/000155837023004860/hrmy-20230329x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-004860
- JSON: https://secwatch.observer/filing/0001558370-23-004860.json
- Plain text: https://secwatch.observer/filing/0001558370-23-004860.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.