Tvardi Therapeutics Inc. ( TVRD ) stock is falling on Monday with a session volume of 5.56 million versus the average volume of 42.08 thousand, as per data from Benzinga Pro.

Tvardi Therapeutics ( TVRD ) provided an update on preliminary data from the Phase 2 REVERT trial of TTI-101 alone or in addition to nintedanib (OFEV) in patients with idiopathic pulmonary fibrosis (IPF).

After reviewing the preliminary safety data and exploratory efficacy results, including changes in Forced Vital Capacity (FVC) (related to lung function), the company concluded that the study did not meet its goals.

The Data

Preliminary data demonstrated that patients’ baseline characteristics were similar across treatment arms, except for the percent predicted FVC, which was lower in the placebo-treated patients (70.1%) compared to the TTI-101-treated arms (74.1% and 81.1%, respectively).

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% vs 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 was not powered to evaluate exploratory endpoints. The number of efficacy evaluable patients with at least one baseline and on-treatment FVC measurement was placebo (n=29), 400mg (n=23), and 800mg (n=27).

The numbers, however, declined by the 12-week timepoint to placebo (n=24), 400mg (n=8), or 800mg (n=13). The preliminary analysis was performed on actual FVC values; values were not modeled or imputed.

Preliminary analysis of exploratory efficacy showed no statistically significant differences between placebo and treatment arms.

Overall, from baseline to last visit on treatment, the proportion of patients who demonstrated FVC improvement from baseline was 41% for the placebo, and 39% and 44% for the 400mg and 800mg arms, respectively.

FVC change from baseline overlapped between treatment arms, with significant variability within each cohort.

The placebo-treated patients’ FVC decline was lower than expected compared to historical controls.

What Next?

Imran Alibhai, Chief Executive Officer of Tvardi, stated, “In the aggregate, we did not observe a benefit of TTI-101 treatment in this IPF study. The limited data set, high variability within treatment arms, and unexpected performance of the placebo arm make it difficult to provide more definitive conclusions at this time. We are conducting additional analyses…”

The company said it remains on track to report preliminary topline data in the first half of 2026 from a healthy volunteer study on TTI-109 and the Phase 2 trial of TTI-101 in hepatocellular carcinoma.

As of June 30, 2025, the company reported $41.0 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the fourth quarter of 2026.

Price Action: Tvardi Therapeutics ( TVRD ) shares were down 84.18% at $6.58 at the time of publication on Monday. The stock is trading near its 52-week low of $15.13, according to Benzinga Pro data.

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