{"schema_version":"secwatch.filing_event.v1","accession":"0001438533-25-000012","form_type":"8-K","ticker":"TVTX","cik":"0001438533","company_name":"Travere Therapeutics, Inc.","filed_at":"2025-03-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.633365+00:00","generated_at":"2026-05-24T15:25:53.147344+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Travere submits sNDA to FDA seeking priority review for FILSPARI in FSGS","bullets":["Submitted sNDA on March 17, 2025 seeking priority review for traditional approval of FILSPARI (sparsentan) for FSGS.","Supported by Phase 3 DUPLEX study (interim FPRE endpoint met; primary eGFR slope missed) and Phase 2 DUET study (met primary endpoint).","FDA has 60 days to decide on acceptance; company expects notice in Q2 2025.","If approved, FILSPARI would be first FDA-approved therapy for FSGS, affecting >40,000 US patients.","No currently approved pharmacologic therapies for FSGS."],"urls":{"canonical":"https://secwatch.observer/filing/0001438533-25-000012","json":"https://secwatch.observer/filing/0001438533-25-000012.json","markdown":"https://secwatch.observer/filing/0001438533-25-000012.md","text":"https://secwatch.observer/filing/0001438533-25-000012.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438533/000143853325000012/0001438533-25-000012-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438533/000143853325000012/tvtx-20250317.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T15:25:53.147344+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"}