Shares of Tvardi Therapeutics (NASDAQ:TVRD) dropped 30% on Monday after the company released weak preliminary results from its Phase 2 REVERT clinical trial testing TTI-101 for the treatment of idiopathic pulmonary fibrosis (IPF).
The clinical-stage biotech firm said the trial failed to meet its objectives based on an initial review of safety and exploratory efficacy data. The double-blind, placebo-controlled study assessed TTI-101, both as a monotherapy and in combination with nintedanib, in 88 patients diagnosed with IPF.
The trial was hit by high discontinuation rates in the treatment arms — 56.7% in the 400 mg group and 62.1% in the 800 mg group — compared to just 10.3% among placebo recipients. Most dropouts were tied to gastrointestinal side effects, especially in patients receiving TTI-101 alongside nintedanib.
Preliminary efficacy analysis showed no statistically meaningful differences between the treatment and placebo arms. After 12 weeks, patients on placebo had a mean forced vital capacity (FVC) decline of 22.2 mL, compared with 61.1 mL in the 400 mg group and 102.8 mL in the 800 mg group.
“In the aggregate, we did not observe a benefit of TTI-101 treatment in this IPF study,” said Imran Alibhai, CEO of Tvardi.
The company noted that the placebo group performed unexpectedly well versus historical benchmarks, complicating the interpretation of trial outcomes.
Despite the failed study, Tvardi emphasized its ongoing development pipeline. It expects to release preliminary data on its next-generation STAT3 inhibitor, TTI-109, and results from a Phase 2 trial of TTI-101 in hepatocellular carcinoma during the first half of 2026.
The company reported $41.0 million in cash and investments as of June 30, 2025, which it expects will fund operations into the fourth quarter of 2026.
Tvardi Therapeutics stock price
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