---
schema_version: "secwatch.filing_event.v1"
accession: "0001558370-24-013103"
form_type: "8-K"
ticker: "HRMY"
cik: "0001802665"
company_name: "Harmony Biosciences Holdings, Inc."
filed_at: "2024-10-01T23:59:59+00:00"
generated_at: "2026-05-30T23:40:39.235192+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Harmony Biosciences highlights best-in-class orexin-2 agonist, $3B revenue goal at Investor Day

## Summary
- BP1.15205 orexin-2 agonist shows highest potency vs. all publicly disclosed competitors, potential best-in-class.
- Pitolisant in IH: mean ESS improvement ~9 points beyond 1 year; majority achieve normal wakefulness; sNDA on track Q4 2024.
- Pitolisant-HD safety data up to 5x highest WAKIX dose; target PDUFA 2028; market research anticipates high uptake.
- Fragile X (ZYN-002): 40% median improvement in social avoidance (p=0.027) in methylated patients; Phase 3 topline mid-2025.
- EPX-100 in Dravet syndrome shows favorable safety vs approved drugs; topline 2026; Phase 3 LGS starts 2024.

## SEC filing metadata
- accession: 0001558370-24-013103
- form_type: 8-K
- ticker: HRMY
- cik: 0001802665
- company_name: Harmony Biosciences Holdings, Inc.
- filed_at: 2024-10-01T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1802665/000155837024013103/0001558370-24-013103-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1802665/000155837024013103/hrmy-20241001x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001558370-24-013103
- JSON: https://secwatch.observer/filing/0001558370-24-013103.json
- Plain text: https://secwatch.observer/filing/0001558370-24-013103.txt

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