{"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","discovered_at":"2026-05-14T18:03:13.071804+00:00","generated_at":"2026-05-31T01:30:23.931285+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Travere pauses Phase 3 HCU trial enrollment due to manufacturing scale-up issues; restart expected in 2026","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001438533-24-000038","json":"https://secwatch.observer/filing/0001438533-24-000038.json","markdown":"https://secwatch.observer/filing/0001438533-24-000038.md","text":"https://secwatch.observer/filing/0001438533-24-000038.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T01:30:23.931285+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}