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Tvardi Therapeutics (NASDAQ: TVRD) reported preliminary Phase 2 REVERT results in idiopathic pulmonary fibrosis showing the study did not meet its goals. 88 patients were randomized to TTI-101 400mg (n=30), 800mg (n=29) or placebo (n=29); 58% received concomitant nintedanib.
Baseline percent predicted FVC was lower in placebo (70.1%) versus TTI-101 arms (74.1%, 81.1%). Discontinuation rates were 10.3% placebo vs 56.7% (400mg) and 62.1% (800mg), driven mainly by gastrointestinal adverse events, higher with nintedanib. At 12 weeks mean FVC change (mL) was placebo -22.2 (n=24), 400mg -61.1 (n=8), 800mg -102.8 (n=13).
Company has $41.0M cash, funding operations into Q4 2026, and expects preliminary topline TTI-109 healthy-volunteer data and TTI-101 HCC Phase 2 data in H1 2026.
Tvardi Therapeutics (NASDAQ: TVRD), a clinical-stage biopharmaceutical company developing oral STAT3-targeting therapies for fibrosis-driven diseases, will participate in the Cantor Global Healthcare Conference. The company's management will engage in a fireside chat on September 4, 2025 at 2:10 PM EDT and conduct one-on-one investor meetings.
The fireside chat will be available via webcast on Tvardi's Investors' website, with replay access for approximately 90 days after the conference.
Tvardi Therapeutics (NASDAQ: TVRD), a clinical-stage biopharmaceutical company, reported its Q2 2025 financial results and business updates. The company completed enrollment in its REVERT IPF Phase 2 trial of TTI-101 for idiopathic pulmonary fibrosis, with topline data expected in Q4 2025. Tvardi also submitted an IND for TTI-109 and completed a merger with Cara Therapeutics to become publicly traded.
Financial highlights include $41.0 million in cash and equivalents, a net income of $4.2 million compared to a $7.0 million loss in Q2 2024, primarily due to a $12.8 million remeasurement gain on Convertible Notes. R&D expenses decreased to $5.8 million, while G&A expenses increased to $3.1 million. The company's cash runway is expected to fund operations into Q4 2026.
Tvardi Therapeutics (NASDAQ: TVRD), a clinical-stage biopharmaceutical company developing oral STAT3-targeting therapies for fibrosis-driven diseases, will participate in the BTIG Virtual Biotechnology Conference. The company's management will engage in a fireside chat on July 30, 2025 at 4:40 PM ET and conduct one-on-one investor meetings.
Investors can access the fireside chat webcast through Tvardi's investor website, with the replay available for approximately 60 days after the conference.
Tvardi Therapeutics (NASDAQ: TVRD) has completed enrollment in its Phase 2 clinical trial of TTI-101 for treating idiopathic pulmonary fibrosis (IPF). The REVERT IPF trial is a randomized, double-blind, placebo-controlled study evaluating TTI-101, an oral small molecule STAT3 inhibitor. The trial focuses on safety and lung function (FVC) endpoints, with topline data expected in Q4 2025.
TTI-101's unique dual mechanism of action inhibits STAT3-driven proliferation while activating T-cells, which has shown promise in preclinical studies by reducing lung fibrosis and restoring lung function. IPF is a chronic, progressive lung disease with poor prognosis, where current treatments only slow progression without halting or reversing fibrosis.
Tvardi Therapeutics (NASDAQ: TVRD), a clinical-stage biopharmaceutical company developing oral small molecule therapies targeting STAT3 for fibrosis-driven diseases, has announced its participation in two upcoming investor conferences. The company will join the Piper Sandler 3rd Annual Virtual Lung Symposium on May 27, 2025, at 11:30 AM ET for a fireside chat. Additionally, Tvardi will present at the Jefferies Global Healthcare Conference in New York on June 4, 2025, at 11:40 AM ET, which will include a corporate presentation and investor meetings. The Jefferies presentation will be available via webcast on Tvardi's Investors' website with a 60-day replay period.
Tvardi Therapeutics (NASDAQ: TVRD) announced its upcoming presentation at the American Thoracic Society 2025 Annual Conference in San Francisco. The presentation will highlight research on their STAT3 inhibitor, TTI-101, for treating idiopathic pulmonary fibrosis (IPF). Key findings show that ~60% of IPF-associated dysregulated genes are not addressed by current approved therapies (nintedanib and pirfenidone), termed the "IPF therapeutic gap." Research using single-cell RNA sequencing identified STAT3 as a dominant regulatory transcription factor in IPF. Notably, TTI-101 showed greater repression of genes within alveolar fibroblasts compared to existing treatments and demonstrated ability to downregulate genes involved in extracellular matrix production, including collagen genes.
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