---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-092776"
form_type: "8-K"
ticker: "HRMY"
cik: "0001802665"
company_name: "Harmony Biosciences Holdings, Inc."
filed_at: "2025-09-24T23:59:59+00:00"
generated_at: "2026-05-17T05:48:14.198973+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Harmony Biosciences' Phase 3 ZYN002 trial in Fragile X syndrome fails primary endpoint

## Summary
- RECONNECT study did not meet primary endpoint of improvement in social avoidance; higher than expected placebo response cited.
- Study enrolled 215 patients aged 3 to <30 years; 1:1 randomization to ZYN002 or placebo over 18 weeks.
- CEO Jeffrey Dayno reaffirms late-stage pipeline; Phase 3 trials for pitolisant HD in narcolepsy and idiopathic hypersomnia on track for Q4 2025.
- Company describes itself as profitable and self-funding biotech with strong cash generation.
- Fragile X syndrome has no FDA-approved therapies; company will conduct comprehensive data analysis.

## SEC filing metadata
- accession: 0001104659-25-092776
- form_type: 8-K
- ticker: HRMY
- cik: 0001802665
- company_name: Harmony Biosciences Holdings, Inc.
- filed_at: 2025-09-24T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1802665/000110465925092776/0001104659-25-092776-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1802665/000110465925092776/hrmy-20250924x8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-092776
- JSON: https://secwatch.observer/filing/0001104659-25-092776.json
- Plain text: https://secwatch.observer/filing/0001104659-25-092776.txt

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