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

Tvardi Therapeutics, Inc.

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.

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