{"schema_version":"secwatch.filing_event.v1","accession":"0001438533-24-000035","form_type":"8-K","ticker":"TVTX","cik":"0001438533","company_name":"Travere Therapeutics, Inc.","filed_at":"2024-09-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.071522+00:00","generated_at":"2026-05-31T06:03:32.381249+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA grants full approval to Travere's FILSPARI for IgA nephropathy based on PROTECT study","bullets":["FDA full approval for FILSPARI (sparsentan) to slow kidney function decline in adults with primary IgAN at risk of disease progression.","PROTECT Study: FILSPARI showed mean eGFR slope -3.0 vs -4.2 mL/min/1.73 m2/year for irbesartan (p=0.0168), a 1.2 mL/min/year treatment effect.","FILSPARI reduced proteinuria by 49.8% vs 15.1% at Week 36 (p<0.0001); effect durable to two years.","Company plans to submit sNDA for potential modification to liver-monitoring REMS."],"urls":{"canonical":"https://secwatch.observer/filing/0001438533-24-000035","json":"https://secwatch.observer/filing/0001438533-24-000035.json","markdown":"https://secwatch.observer/filing/0001438533-24-000035.md","text":"https://secwatch.observer/filing/0001438533-24-000035.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1438533/000143853324000035/0001438533-24-000035-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1438533/000143853324000035/tvtx-20240905.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T06:03:32.381249+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"}