---
schema_version: "secwatch.filing_event.v1"
accession: "0001438533-24-000038"
form_type: "8-K"
ticker: "TVTX"
cik: "0001438533"
company_name: "Travere Therapeutics, Inc."
filed_at: "2024-09-26T23:59:59+00:00"
generated_at: "2026-05-31T01:30:23.931285+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Travere pauses Phase 3 HCU trial enrollment due to manufacturing scale-up issues; restart expected in 2026

## Summary
- Voluntary pause of enrollment in Phase 3 HARMONY Study for pegtibatinase (classical homocystinuria).
- Desired drug substance profile not achieved in recent scale-up process; process improvements needed.
- Currently enrolled patients continue to receive study medication from small scale batches without disruption.
- Earliest date to restart enrollment expected in 2026 while company evaluates commercial process improvements.

## SEC filing metadata
- accession: 0001438533-24-000038
- form_type: 8-K
- ticker: TVTX
- cik: 0001438533
- company_name: Travere Therapeutics, Inc.
- filed_at: 2024-09-26T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438533/000143853324000038/0001438533-24-000038-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438533/000143853324000038/tvtx-20240926.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438533-24-000038
- JSON: https://secwatch.observer/filing/0001438533-24-000038.json
- Plain text: https://secwatch.observer/filing/0001438533-24-000038.txt

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