---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-23-016428"
form_type: "8-K"
ticker: "HRMY"
cik: "0001802665"
company_name: "Harmony Biosciences Holdings, Inc."
filed_at: "2023-10-13T23:59:59+00:00"
generated_at: "2026-06-10T00:07:44.755419+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Phase 3 INTUNE study for pitolisant in idiopathic hypersomnia misses primary endpoint

## Summary
- Primary endpoint (ESS change) did not reach statistical significance between pitolisant and placebo in the randomized withdrawal phase.
- 83% of patients completing open-label phase responded with average ESS improvement of 9.4 points; 88% continued into long-term extension.
- Positive trends favoring pitolisant observed on IHSS (approached significance) and Sleep Inertia Questionnaire.
- Safety profile consistent with established pitolisant profile; no new safety signals.
- Company plans to discuss full data with FDA to determine next steps for pitolisant in IH.

## SEC filing metadata
- accession: 0001558370-23-016428
- form_type: 8-K
- ticker: HRMY
- cik: 0001802665
- company_name: Harmony Biosciences Holdings, Inc.
- filed_at: 2023-10-13T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1802665/000155837023016428/0001558370-23-016428-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1802665/000155837023016428/hrmy-20231013x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-23-016428
- JSON: https://secwatch.observer/filing/0001558370-23-016428.json
- Plain text: https://secwatch.observer/filing/0001558370-23-016428.txt

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