{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-098908","form_type":"8-K","ticker":"TVRD","cik":"0001346830","company_name":"Tvardi Therapeutics, Inc.","filed_at":"2025-10-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.205217+00:00","generated_at":"2026-05-17T03:51:52.231023+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Tvardi Therapeutics Phase 2 IPF trial misses endpoints; no benefit from TTI-101","bullets":["Trial did not meet goals; no statistically significant difference between TTI-101 and placebo on FVC change.","High discontinuation rates in TTI-101 arms (56.7% and 62.1%) vs placebo (10.3%), driven by GI adverse events, especially with nintedanib.","Placebo arm FVC decline lower than historical controls; at 12 weeks, mean FVC change: placebo -22.2 mL, 400mg -61.1 mL, 800mg -102.8 mL.","Cash of $41M as of June 30, 2025 expected to fund into Q4 2026; next-gen STAT3 inhibitor TTI-109 and HCC trial data on track for H1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-098908","json":"https://secwatch.observer/filing/0001104659-25-098908.json","markdown":"https://secwatch.observer/filing/0001104659-25-098908.md","text":"https://secwatch.observer/filing/0001104659-25-098908.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1346830/000110465925098908/0001104659-25-098908-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1346830/000110465925098908/tm2528638d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:51:52.231023+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"}