Core Insights - Tvardi Therapeutics Inc. reported disappointing preliminary data from the Phase 2 REVERT trial of TTI-101 for idiopathic pulmonary fibrosis (IPF), indicating that the study did not meet its goals [2][7] Data Summary - The study showed that baseline characteristics were similar across treatment arms, but the percent predicted Forced Vital Capacity (FVC) was lower in the placebo group (70.1%) compared to TTI-101 treated arms (74.1% and 81.1%) [2] - Discontinuation rates were imbalanced, with the placebo group having a lower rate (10.3%) compared to the treated arms (56.7% for 400mg and 62.1% for 800mg) [3] - The primary reason for discontinuation in the TTI-101 population was gastrointestinal adverse events, particularly among patients on concurrent nintedanib [3] - The number of efficacy evaluable patients decreased significantly by the 12-week timepoint, with placebo (n=24), 400mg (n=8), and 800mg (n=13) [4] - No statistically significant differences in exploratory efficacy were observed between placebo and treatment arms, with FVC improvement proportions being 41% for placebo, 39% for 400mg, and 44% for 800mg [5] - The placebo-treated patients' FVC decline was lower than expected compared to historical controls [6] Future Outlook - The CEO of Tvardi stated that the company did not observe a benefit of TTI-101 treatment in this study and is conducting additional analyses [7] - The company plans 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 [7] Financial Position - As of June 30, 2025, Tvardi reported $41.0 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the fourth quarter of 2026 [8] - Tvardi Therapeutics shares were down 84.18% at $6.58, trading near its 52-week low of $15.13 [8]