공시 • May 03
Tvardi Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $12.5 million. Tvardi Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $12.5 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering 공시 • Mar 09
Tvardi Therapeutics, Inc., Annual General Meeting, Jun 09, 2026 Tvardi Therapeutics, Inc., Annual General Meeting, Jun 09, 2026. 공시 • Jan 08
Tvardi Therapeutics Announces Further Phase 2 REVERT IPF Data, Expanding Clinical Insights Tvardi Therapeutics, Inc. provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF), with preliminary results previously announced on October 13, 2025. Additional analysis was conducted to assess the impact of STAT3 inhibition using TTI-101 on fibrosis, inflammatory markers and pulmonary function, and this analysis was limited to patients who were exposed to the study drug for 12 weeks. Following review of pharmacokinetics and adverse events, one patient was removed from the analysis due to receiving less than 60% of the expected dosing, two patients were removed due to no measurable TTI-101 observed in the blood and no reported adverse events, and one additional patient was removed as an outlier because pulmonary function initially improved on treatment but was later severely impacted by acute bronchitis deemed unrelated to the study drug. This resulted in a dataset of 40 patients analyzed, including 16 pooled patients treated with TTI-101 and 24 patients treated with placebo. Data highlights showed that fibrosis decline was greater in patients treated with TTI-101 compared to placebo, at -9.4% versus -2.4%, respectively, based on baseline-weighted high resolution CT lung fibrosis scores that were centrally read, blinded and independently assessed. In terms of inflammation, a greater decline in IL-6 was observed among TTI-101-treated patients compared to placebo, with an even greater reduction seen in patients with higher baseline IL-6 levels; IL-6 is a key pro-inflammatory cytokine that signals through STAT3, and inhibition of STAT3 is expected to reduce downstream inflammatory signaling associated with disease. Additionally, 63% of pooled patients treated with TTI-101 demonstrated an increase in forced vital capacity (FVC) at 12 weeks compared to 46% of patients in the placebo group, and the mean FVC change in TTI-101-treated patients was -15 mL, representing a smaller decline than observed in the REVERT placebo group (-22 mL) and historical placebo groups from comparable IPF trials. The REVERT IPF Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study of TTI-101 alone or in combination with nintedanib (OFEV®) in patients with IPF, designed to assess safety, pharmacokinetics and exploratory outcomes related to lung function, and Tvardi announced on October 13, 2025 that the study did not meet its goals after reviewing preliminary safety data and efficacy results. 공시 • Oct 14
Tvardi Therapeutics, Inc. Provides Update on Preliminary Data from Phase 2 REVERT Trial in Idiopathic Pulmonary Fibrosis Tvardi Therapeutics, Inc. provided an update on preliminary data from the Phase 2 REVERT clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). The REVERT IPF Phase 2 clinical trial was a randomized, double-blind, placebo-controlled clinical trial of TTI- 101 alone or in addition to nintedanib (OFEV) in patients with IPF. 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 (FVC), the Company concluded that the study did not meet its goals. Overall, 88 patients were randomized to TTI-101 400mg per day (n=30), 800mg per day (n=29) or placebo (n=29), and stratified by nintedanib use, with 58% of patients receiving concomitant therapy. Preliminary data demonstrated patients' baseline characteristics were similar across treatment arms, with the exception of% 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). Disconuation 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 large variability within each cohort. Notably, the placebo-treated patients' FVC decline was lower than expected compared to historical controls. New Risk • Oct 13
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 26% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings are forecast to decline by an average of 46% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$146m net loss in 3 years). 
