Tvardi Therapeutics is a clinical-stage biopharmaceutical company developing oral, small molecule drugs that directly inhibit STAT3, a protein that drives inflammation, cellular proliferation, and immune dysregulation across a range of cancers and inflammatory diseases. STAT3 was historically considered "undruggable," and Tvardi argues its approach is differentiated by selectively blocking STAT3's disease-driving function without impairing its separate role in mitochondrial respiration — a distinction that caused safety problems in earlier compounds. Tvardi has two pipeline assets and no approved products or revenue. TTI-101 is a first-generation direct STAT3 inhibitor currently in a Phase 1b/2 trial in hepatocellular carcinoma (HCC), with topline data expected in H2 2026. TTI-109 is a prodrug of TTI-101, designed to reduce GI exposure to the active molecule before systemic absorption; a Phase 1 healthy volunteer trial is underway, with topline data expected in Q2 2026, after which Tvardi plans to select a Phase 2 indication. Target disease areas include HCC, IPF, inflammatory bowel disease, and systemic sclerosis. Tvardi funds operations through equity financing, retains worldwide rights to all product candidates, and licenses foundational technology from Baylor College of Medicine under agreements that include milestone payments and low-single-digit royalties on future net sales. If products are approved, Tvardi would commercialize them independently in focused markets or through partnerships with larger pharmaceutical companies.