---
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"
generated_at: "2026-05-17T03:51:52.231023+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-098908
- JSON: https://secwatch.observer/filing/0001104659-25-098908.json
- Plain text: https://secwatch.observer/filing/0001104659-25-098908.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.