Tvardi Therapeutics, Inc.

Tvardi Therapeutics, Inc. (Nasdaq: TVTX) is a clinical-stage biopharmaceutical company focused on developing novel, oral, small molecule therapies targeting Signal Transducer and Activator of Transcription 3 (STAT3) to treat inflammatory and proliferative diseases with significant unmet medical need. The company's website is www.tvarditx.com.

The company's pipeline consists of two oral, small molecule STAT3 inhibitors. TTI-101 is the first-generation direct STAT3 inhibitor currently in Phase 1b/2 clinical development for hepatocellular carcinoma, with the FDA having granted both Orphan Drug Designation for IPF and HCC as well as Fast-Track Designation for HCC. TTI-109 is a phosphate prodrug of TTI-101 designed to enhance delivery while maintaining the same mechanism of action, with an IND application accepted by the FDA in June 2025 and a Phase 1 trial underway in healthy volunteers.

Tvardi's scientific approach is rooted in expertise regarding STAT3's functional composition and its critical role in disease pathogenesis. The company's strategy targets phosphorylated tyrosine residue 705 (pY-STAT3) to selectively inhibit STAT3's role as a transcription factor without affecting its essential mitochondrial functions. This direct inhibition approach is designed to simultaneously modulate both intrinsic proliferative pathways within diseased cells and extrinsic immune dysregulation, differentiating it from therapies targeting single upstream pathways.

Preclinical studies have demonstrated TTI-101's efficacy across multiple disease models including idiopathic pulmonary fibrosis, systemic sclerosis, inflammatory bowel disease, and hepatocellular carcinoma. Clinical data from the REVERT IPF Phase 2 trial showed greater reductions in fibrosis score and IL-6 levels in adequately exposed patients compared to placebo, providing human clinical proof of concept for the STAT3 inhibition mechanism. In oncology Phase 1 trials, 100 percent of patients with elevated baseline pY-STAT3 demonstrated decreased pY-STAT3 levels within approximately six weeks of TTI-101 therapy.

The company was formed through a merger between Legacy Tvardi and Cara Therapeutics, Inc., which closed on April 15, 2025, with Cara changing its name to Tvardi Therapeutics, Inc. As a smaller reporting company and emerging growth company, Tvardi operates as a pre-revenue clinical-stage entity dependent on raising capital to fund its development programs.