What Tvardi Therapeutics does

Tvardi Therapeutics is a clinical-stage biopharmaceutical company founded in 2017 and headquartered in Sugar Land, Texas (Greater Houston area). The company develops oral small molecule inhibitors of STAT3 (Signal Transducer and Activator of Transcription 3), a transcription factor that integrates multiple fibrotic and oncogenic signaling pathways. Tvardi's lead compound TTI-101 is a direct STAT3 inhibitor that binds tightly to the SH2 domain, blocking phosphorylation at tyrosine 705 and subsequent dimerization and nuclear translocation while preserving non-canonical mitochondrial functions. A second asset, TTI-109, is a next-generation phosphate prodrug of TTI-101 currently in Phase 1 healthy volunteer trials. TTI-101 is being evaluated in two Phase 2 trials: the REVERT Liver Cancer trial in hepatocellular carcinoma (HCC) as monotherapy and in combination with pembrolizumab or atezolizumab plus bevacizumab, and the completed REVERT IPF trial in idiopathic pulmonary fibrosis. FDA has granted TTI-101 Orphan Drug Designation in both HCC and IPF, plus Fast Track Designation in HCC.

The company became publicly traded on Nasdaq under the ticker TVRD on April 16, 2025, following a merger with Cara Therapeutics that included a concurrent approximately $28 million PIPE private placement. Tvardi had previously raised $74 million in a Series B financing in June 2021. As of Q1 2026, the company held $25.0 million in cash with a stated runway through Q4 2026. Management comprises a CEO (Imran Alibhai, PhD) and CFO (Dan Conn) with biotech investment banking backgrounds, a board-certified oncologist CMO (Dr. John Kauh, formerly of HUTCHMED and Eli Lilly), and a CSO and Scientific Advisory Board chair (Jeno Gyuris); the scientific IP originated with Dr. David Tweardy at MD Anderson Cancer Center.

Tvardi's business model is pre-revenue drug development. The company has no commercial products and generates no product revenue. Future revenue would derive from FDA-approved commercialization of TTI-101 or TTI-109, or from licensing or partnership arrangements for development and commercialization rights. Customer segments are defined by disease indication rather than paying customers today: HCC patients (treatment-naive, post-immunotherapy, and multi-systemic-therapy lines), IPF patients, and a broader set of fibrosis-driven and STAT3-mediated inflammatory/proliferative disease populations. The clinical-stage biotech reaches end users through investigator-sponsored and company-sponsored clinical trial sites (e.g., Emory University Hospital for REVERT IPF), while engaging institutional investors and KOLs through healthcare conferences (Jefferies, Raymond James, Oppenheimer, TD Cowen, Barclays) and peer-reviewed scientific publications.

Name

Tvardi Therapeutics

Legal name

Tvardi Therapeutics, Inc.

Website

https://tvarditherapeutics.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Tvardi Therapeutics is a clinical-stage biopharmaceutical company developing oral small molecule STAT3 inhibitors (TTI-101 and TTI-109) for fibrosis-driven diseases including hepatocellular carcinoma and idiopathic pulmonary fibrosis. Publicly traded on Nasdaq as TVRD since April 2025.

Ownership category

akta.pro rank

Product category

Clinical-Stage Biopharmaceutical Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Theranostic Radiopharmaceutical Platforms (Paired Dx/Tx) (HLAIAGAC)

Keywords

• STAT3 inhibitor therapeutics
• Oral small molecule drugs
• Fibrosis-driven disease treatments
• Hepatocellular carcinoma therapy
• Idiopathic pulmonary fibrosis drugs

Headquarters

HQ city

Houston

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Product Revenue: Tvardi is a clinical-stage biopharmaceutical company with no current commercial products. The company is developing TTI-101 for hepatocellular carcinoma and TTI-109 for inflammatory/proliferative diseases. Revenue will be generated upon FDA approval and commercialization of therapeutic candidates.
2. Potential Licensing/Partnership Revenue: As a clinical-stage company, future revenue may come from licensing agreements or strategic partnerships for drug development and commercialization rights, particularly given the Fast Track and Orphan Drug Designations for TTI-101 in HCC.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Tvardi Therapeutics is a clinical-stage biopharmaceutical company developing oral small molecule STAT3 inhibitors for the treatment of fibrosis-driven and inflammatory/proliferative diseases. Its lead candidate TTI-101 is in Phase 2 clinical trials for hepatocellular carcinoma (as monotherapy and in combination with pembrolizumab or atezolizumab plus bevacizumab) and idiopathic pulmonary fibrosis, while its next-generation compound TTI-109 is in Phase 1 healthy volunteer trials. The drugs work by binding the SH2 domain of STAT3 to block phosphorylation, dimerization, and nuclear translocation, preserving non-canonical mitochondrial functions.

Product overview

Tvardi Therapeutics is a clinical-stage biopharmaceutical company developing two oral small molecule STAT3 inhibitors: TTI-101 (first-generation direct STAT3 inhibitor) and TTI-109 (next-generation phosphate prodrug). TTI-101 is in Phase 2 clinical trials for hepatocellular carcinoma (HCC) as monotherapy and in combination with standard-of-care treatments (pembrolizumab or atezolizumab + bevacizumab). TTI-109 is in Phase 1 in healthy volunteers to evaluate safety, tolerability, pharmacokinetics, and bioequivalence to TTI-101. Both compounds target STAT3 by binding to its SH2 domain, inhibiting canonical nuclear function while preserving non-canonical functions associated with cellular respiration.

Differentiator

Problem solved

Functional benefit

Products and services

• TTI-101

Quantifiable outcome

• 9.4% baseline-weighted fibrosis score reduction vs 2.4% for placebo at week 12 in Phase 2 REVERT IPF trial
• +2 more outcomes

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

One partnership is on record.

• Emory University HospitalcoreStrategic or Co-development PartnerClinical trial site for the REVERT IPF (Idiopathic Pulmonary Fibrosis) Phase 2 clinical trial of TTI-101. The Atlanta, Georgia location is conducting the trial under contact person Mitzi Near, RN.

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Pliant Therapeutics: Clinical-stage biotech focused on integrin-based therapies for IPF and other fibrotic diseases. Directly comparable to Tvardi as a similarly-sized clinical-stage company targeting fibrotic indications with novel mechanisms, providing a useful IPF-specific benchmark for Tvardi's STAT3 program.
• FibroGen: Biotech focused on fibrosis and anemia with roxadustat approved in select markets and a pipeline including CTGF inhibitors for IPF. Directly comparable as a fibrosis-focused company with both therapeutic biologic and small molecule assets addressing fibrotic indications overlapping with Tvardi's IPF program.
• Disc Medicine: Clinical-stage hematology biotech developing therapeutics for rare blood disorders including anemia and myelofibrosis. Comparable as a Nasdaq-listed clinical-stage biotech with similar size, pipeline stage, and orphan drug strategy that may overlap with Tvardi's fibrosis-driven disease focus.
• SpringWorks Therapeutics: Clinical-stage and recently commercializing biotech focused on rare diseases and cancer (GAMMAPEX in oncology, nirogacestat in desmoid tumors). Comparable as a Nasdaq-listed clinical-stage biotech with multiple programs and similar pipeline-stage profile to Tvardi.
• Nuvalent: Clinical-stage oncology biotech developing novel kinase inhibitors with high selectivity. Comparable as a Nasdaq-listed clinical-stage biotech with proprietary chemistry targeting validated oncology drivers, similar size and growth trajectory.
• Madrigal Pharmaceuticals: Recently commercialized Rezdiffra (resmetirom) as the first FDA-approved MASH therapy, with strong applicability to broader liver disease including HCC risk populations. Highly relevant comparator for Tvardi's HCC program and serves as a model for clinical-stage liver-focused biotechs achieving commercialization.
• Revolution Medicines: Clinical-stage oncology biotech developing RAS(ON) inhibitors with novel mechanism of action. Comparable as a Nasdaq-listed clinical-stage biotech pursuing difficult oncology targets with proprietary chemistry, similar in scale and approach to Tvardi.
• Structure Therapeutics: Clinical-stage biotech developing oral small molecules for GPCR-driven diseases. Comparable as a similarly-sized, Nasdaq-listed clinical-stage company developing novel oral small molecule therapeutics targeting historically challenging protein classes.

Broad incumbents

• United Therapeutics: Established commercial-stage biopharma specializing in pulmonary hypertension and IPF (Tyvaso, Tyvaso DPI). Relevant as a broad incumbent in pulmonary disease with significant IPF exposure and established commercial infrastructure Tvardi would need to compete against.
• Boehringer Ingelheim: Major global pharmaceutical company with established IPF franchise (Ofev) and the recently approved JASCAYD (nerandomilast). Critical competitive benchmark as the dominant IPF player that has now raised the efficacy/tolerability bar in the indication Tvardi is targeting.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/tvarditherap
• LinkedInlinkedin.com/company/tvardi

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds2 records

Investors6 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Tvardi Therapeutics