secwatch.observer — SEC 8-K summary
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Issuer:     Tvardi Therapeutics, Inc. (TVRD)
CIK:        0001346830
Form:       8-K
Filed at:   2025-10-14T23:59:59+00:00
Accession:  0001104659-25-098908
Event type: other_material
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tvardi Therapeutics Phase 2 IPF trial misses endpoints; no benefit from TTI-101
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1346830/000110465925098908/0001104659-25-098908-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1346830/000110465925098908/tm2528638d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-098908

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer