Tvardi Therapeutics Shares Drop After TTI-101 Trial Doesn't Meet Goals

Dow Jones

Oct 13, 2025

By Chris Wack

Tvardi Therapeutics shares were 30% lower, at $7.19, in premarket trading after the company said its phase 2 study for TTI-101 didn't meet its goals.

TTI-101 is a small molecule therapy targeting STAT3 proteins in order to treat idiopathic pulmonary fibrosis .

The biopharmaceutical company said the study was a randomized clinical trial of TTI-101 alone aimed at patients with idiopathic pulmonary fibrosis.

The study was designed to assess safety, pharmacokinetics, and exploratory outcomes related to lung function.

After reviewing the preliminary safety data and exploratory efficacy results, including changes in forced vital capacity, the company concluded that the study didn't meet its goals.

Discontinuation rates across treatment arms were imbalanced, with lower discontinuation rates observed in the placebo group--10.3%--compared to treated arms (400mg and 800mg; 56.7% versus 62.1%, respectively). Discontinuation rates among the TTI-101 population were primarily driven by gastrointestinal adverse events, with higher rates of events and discontinuations among patients on concurrent nintedanib.

The study wasn't powered to evaluate exploratory endpoints. Preliminary analysis of exploratory efficacy showed no statistically significant differences between placebo and treatment arms.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 13, 2025 08:13 ET (12:13 GMT)

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