Tvardi Therapeutics, Inc.

The company is a clinical-stage biopharmaceutical company focused on developing new oral, small molecule therapies. These therapies target Signal Transducer and Activator of Transcription 3 (STAT3) to treat inflammatory and proliferative diseases where current treatments are insufficient. The company's approach directly inhibits STAT3, a target that has historically been difficult to drug. Its pipeline includes two oral, small molecule STAT3 inhibitors: TTI-101 and TTI-109. TTI-101 is a first-generation direct STAT3 inhibitor currently in Phase 1b/2 clinical development for hepatocellular carcinoma (HCC). TTI-109 is a phosphate prodrug of TTI-101, designed to enhance STAT3 targeting while maintaining the same mechanism of action. An Investigational New Drug (IND) application for TTI-109 was filed in June 2025, and a Phase 1 trial in healthy volunteers evaluating safety, tolerability, pharmacokinetics, and bioequivalence to TTI-101 was initiated after FDA acceptance. Topline data from this trial is expected in the second quarter of 2026, after which the clinical indication for TTI-109 will be announced. The company is currently enrolling patients in the REVERT LIVER CANCER Phase 1b/2 clinical trial of TTI-101 in patients with HCC. The anticipated data readout for this trial has been extended from the first half of 2026 to the second half of 2026 to allow for data maturation, including longitudinal and translational assessments, characterization of durability, and dose optimization, potentially adding up to 15 participants in the monotherapy arm.