---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-25-008525"
form_type: "8-K"
ticker: "HRMY"
cik: "0001802665"
company_name: "Harmony Biosciences Holdings, Inc."
filed_at: "2025-06-11T23:59:59+00:00"
generated_at: "2026-05-19T13:43:58.968353+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Harmony Biosciences Presents Preclinical Data for BP1.15205 OX2R Agonist in Narcolepsy

## Summary
- Data presented at SLEEP 2025 showed significant wake-promoting and cataplexy-suppressing effects in transgenic mouse model of narcolepsy type 1.
- BP1.15205 demonstrated high potency (EC50=0.015 nM) and >600-fold selectivity over human OX1R.
- No adverse events were observed in 3-month GLP toxicity study at doses up to 300 mg/kg/day.
- First-in-human study planned for 2H 2025 with topline data anticipated in 2026.
- IMPD application with EMA being completed; IND for BP1.15205 to be filed with FDA.

## SEC filing metadata
- accession: 0001558370-25-008525
- form_type: 8-K
- ticker: HRMY
- cik: 0001802665
- company_name: Harmony Biosciences Holdings, Inc.
- filed_at: 2025-06-11T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1802665/000155837025008525/0001558370-25-008525-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1802665/000155837025008525/hrmy-20250611x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-25-008525
- JSON: https://secwatch.observer/filing/0001558370-25-008525.json
- Plain text: https://secwatch.observer/filing/0001558370-25-008525.txt

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