{"schema_version":"secwatch.filing_event.v1","accession":"0001438533-25-000032","form_type":"8-K","ticker":"TVTX","cik":"0001438533","company_name":"Travere Therapeutics, Inc.","filed_at":"2025-05-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.303458+00:00","generated_at":"2026-05-21T04:48:17.465560+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA accepts Travere's sNDA for FILSPARI in FSGS; PDUFA Jan 13, 2026","bullets":["FDA accepted sNDA for traditional approval of FILSPARI (sparsentan) to treat focal segmental glomerulosclerosis (FSGS).","PDUFA target action date is January 13, 2026; FDA plans an advisory committee meeting.","If approved, FILSPARI would be first FDA-approved drug for FSGS, affecting over 40,000 U.S. patients.","sNDA supported by Phase 3 DUPLEX (met interim proteinuria endpoint, missed primary eGFR slope) and Phase 2 DUET studies.","No approved pharmacologic treatment currently exists for FSGS."],"urls":{"canonical":"https://secwatch.observer/filing/0001438533-25-000032","json":"https://secwatch.observer/filing/0001438533-25-000032.json","markdown":"https://secwatch.observer/filing/0001438533-25-000032.md","text":"https://secwatch.observer/filing/0001438533-25-000032.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438533/000143853325000032/0001438533-25-000032-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438533/000143853325000032/tvtx-20250515.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-21T04:48:17.465560+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"}