Tvardi Therapeutics Stock Price, News & Analysis

Tvardi Therapeutics, Inc. (NASDAQ: TVRD) is a clinical-stage biopharmaceutical company focused on developing novel, oral small molecule therapies that target the transcription factor STAT3 to treat fibrosis-driven diseases with significant unmet medical need. According to the company’s public disclosures, STAT3 is described as a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression, and is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells.

Following a merger completed on April 15, 2025, the Delaware corporation formerly known as Cara Therapeutics, Inc. changed its name to Tvardi Therapeutics, Inc., and the business conducted by the combined company became primarily the business conducted by Legacy Tvardi. As of the open of trading on April 16, 2025, the company’s common stock began trading on The Nasdaq Capital Market under the symbol TVRD. Tvardi is classified under the healthcare sector and biotechnology industry and is identified in SEC filings as a smaller reporting company.

Tvardi’s development efforts center on inhibiting STAT3 through oral small molecules. Its lead product candidate, TTI-101, is characterized in company materials as an oral, small molecule inhibitor of STAT3. Tvardi has disclosed that it is conducting clinical trials of TTI-101 in hepatocellular carcinoma (HCC) under clinical trial identifier NCT05440708. The company has also reported conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need, including idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma, and has described the REVERT IPF Phase 2 trial of TTI-101 as a randomized, double-blind, placebo-controlled clinical trial in patients with IPF designed to assess safety, pharmacokinetics and exploratory outcomes related to lung function.

In addition to TTI-101, Tvardi is advancing a second clinical candidate, TTI-109, which the company describes as a next-generation STAT3 inhibitor that is structurally related to, yet chemically distinct from, TTI-101 and designed to enhance the ability to target STAT3. Tvardi has reported that an Investigational New Drug (IND) application for TTI-109 was submitted to the U.S. Food and Drug Administration and that a healthy volunteer study of TTI-109 has been initiated, with the program characterized as a Phase 1 study in healthy volunteers.

Tvardi has provided detailed updates on its REVERT IPF Phase 2 clinical trial of TTI-101 in idiopathic pulmonary fibrosis. The company has stated that the trial was a randomized, double-blind, placebo-controlled study of TTI-101 alone or in addition to nintedanib (OFEV) in patients with IPF, with key endpoints including safety and lung function (Forced Vital Capacity, or FVC). After reviewing preliminary safety data and exploratory efficacy results, including changes in FVC, Tvardi reported that the study did not meet its goals. Subsequent analyses limited to patients exposed to study drug for 12 weeks were conducted to interrogate the impact of STAT3 inhibition on fibrosis, inflammatory markers and pulmonary function, and the company has described data showing greater decline in CT-based lung fibrosis scores and greater IL-6 reductions in pooled TTI-101-treated patients compared to placebo, as well as differences in FVC outcomes, while noting variability and limitations in the dataset.

Beyond IPF, Tvardi has highlighted its ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 in hepatocellular carcinoma and has referenced interim results from this study that, according to company statements, demonstrated clinically meaningful activity of TTI-101 both as monotherapy and in combination with established anti-cancer agents across treatment lines. The company has indicated that it is progressing this Phase 2 study in HCC and has discussed anticipated topline data timelines in its public communications.

Tvardi’s corporate and financial disclosures emphasize its focus on STAT3 inhibition as a therapeutic approach across fibrotic and oncology indications. The company has described TTI-101 as having a dual mechanism of action in preclinical studies, involving inhibition of STAT3-driven proliferation and activation of T-cells, with reported effects on lung fibrosis and lung function in preclinical IPF models. For TTI-109, Tvardi has stated that the molecule is designed to rapidly convert to TTI-101 and lessen exposure of the active drug to the intestinal lining, with the potential, as described by the company, to improve tolerability and provide a more efficient delivery mechanism for TTI-101.

From a corporate perspective, Tvardi has reported that it operates as a single reportable segment focused on research and development of its STAT3-targeted product candidates. SEC filings and press releases describe the company’s activities as including clinical development, regulatory interactions such as IND submissions, and participation in healthcare and biotechnology investor conferences. The company has also disclosed severance and change-in-control arrangements for certain employees, as well as retention equity awards for named executive officers, in connection with its ongoing development programs and corporate evolution following the merger.

Investors researching TVRD stock can use this overview to understand that Tvardi Therapeutics, Inc. is a Nasdaq-listed, clinical-stage biopharmaceutical company whose primary business is the development of oral small molecule inhibitors of STAT3, with active clinical programs in idiopathic pulmonary fibrosis, hepatocellular carcinoma and a healthy volunteer study of its next-generation STAT3 inhibitor TTI-109, as described in its press releases and SEC filings.