{"schema_version":"secwatch.filing_event.v1","accession":"0001438533-25-000049","form_type":"8-K","ticker":"TVTX","cik":"0001438533","company_name":"Travere Therapeutics, Inc.","filed_at":"2025-09-10T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.998649+00:00","generated_at":"2026-05-17T06:58:47.891568+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA says no advisory committee needed for FILSPARI sNDA in FSGS; PDUFA Jan 13, 2026","bullets":["FDA informed Travere that an advisory committee is no longer needed for the FILSPARI (sparsentan) sNDA for FSGS.","The sNDA remains under review with a PDUFA target action date of January 13, 2026.","If approved, FILSPARI would be the first medication indicated for FSGS, a rare kidney disorder.","sNDA is supported by Phase 3 DUPLEX and Phase 2 DUET studies showing superior proteinuria reduction vs. irbesartan.","FILSPARI is already fully approved for IgA nephropathy in the US and EU."],"urls":{"canonical":"https://secwatch.observer/filing/0001438533-25-000049","json":"https://secwatch.observer/filing/0001438533-25-000049.json","markdown":"https://secwatch.observer/filing/0001438533-25-000049.md","text":"https://secwatch.observer/filing/0001438533-25-000049.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438533/000143853325000049/0001438533-25-000049-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438533/000143853325000049/tvtx-20250910.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:58:47.891568+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"}