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TVRD Stock Plunges 84% After Phase II Fibrosis Study Misses Key Goals
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Key Takeaways
{\"0\":\"Tvardi Therapeutics stock tumbled 83.9% after disappointing preliminary phase II REVERT IPF study data.\",\"1\":\"TTI-101 failed to show meaningful improvement in lung function or efficacy compared with placebo.\",\"2\":\"High discontinuation rates and gastrointestinal side effects in TTI-101 arms weighed on study outcomes.\"}
Shares of Tvardi Therapeutics (TVRD - Free Report) nosedived 83.9% on Monday after the company provided a disappointing update following an analysis of preliminary data from a mid-stage study of its lead investigational candidate, TTI-101, to treat idiopathic pulmonary fibrosis (IPF). TTI-101 is TVRD’s oral small molecule therapy targeting STAT3.
Tvardi Therapeutics’ phase II REVERT IPF study evaluated TTI-101, either as a monotherapy or in combination with Boehringer Ingelheim’s Ofev (nintedanib), in IPF patients. The primary goals were to assess safety, pharmacokinetics and exploratory measures of lung function. A total of 88 patients were enrolled to receive either a 400/800 mg/day dose of the candidate or placebo, and stratified based on Ofev use, with 58% receiving concomitant therapy.
TVRD’s Phase II IPF Study Data in Detail
According to Tvardi Therapeutics’ preliminary data readout, the phase II REVERT IPF study did not achieve its intended objectives based on the safety and efficacy findings, including changes in Forced Vital Capacity (FVC), which is a crucial measurement in pulmonary function tests. Baseline characteristics were generally balanced across treatment groups, and TTI-101 therapy did not demonstrate a meaningful benefit over placebo. The placebo group had a slightly lower mean predicted FVC (70.1%) compared with the TTI-101 400 mg and 800 mg groups (74.1% and 81.1%, respectively).
Tvardi Therapeutics also reported that the study was not statistically powered to assess exploratory efficacy outcomes. The number of evaluable patients with at least one baseline and on-treatment FVC measurement declined over the 12-week duration in all study groups.
Year to date, TVRD stock has plunged 63.6% against the industry’s 7.3% growth.
Image Source: Zacks Investment Research
Furthermore, analysis of exploratory efficacy showed no statistically significant differences between TTI-101 and placebo. The proportion of patients achieving FVC improvement from baseline was comparable across all groups (41% for placebo, and 39% and 44% for the 400 mg and 800 mg cohorts, respectively). FVC changes overlapped substantially between arms, with high variability observed within each treatment group. Interestingly, the FVC decline in the placebo group was lower than expected relative to historical data, further contributing to the lack of differentiation between treatment arms.
Tvardi Therapeutics added that discontinuation rates varied notably across treatment groups, with fewer patients discontinuing in the placebo arm (10.3%) compared to the TTI-101 400 mg and 800 mg groups (56.7% and 62.1%, respectively). Most discontinuations in the TTI-101 arms were associated with gastrointestinal adverse events, particularly among patients who were also receiving Ofev.
TVRD’s Next Steps in the TTI-101 Development Process
Tvardi Therapeutics is currently conducting additional analysis of the phase II REVERT IPF study data to better understand the results and determine its next steps in the development of TTI-101 for IPF.
Apart from the IPF indication, the company is also currently evaluating TTI-101 in a separate phase II study for hepatocellular carcinoma. Its clinical-stage pipeline comprises another candidate, TTI-109, a next-generation STAT3 inhibitor, which is currently being evaluated in an early-stage healthy volunteer study. The company is reportedly on track to announce top-line data from both these studies in the first half of 2026.
Per Tvardi Therapeutics, TTI-109 is designed to build on TTI-101’s mechanism of action by serving as a more efficient STAT3-targeting agent, with the potential to enhance drug delivery and improve tolerability. Following completion of the TTI-109 study, the company plans to evaluate opportunities to expand into additional STAT3-driven indications.
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TVRD Stock Plunges 84% After Phase II Fibrosis Study Misses Key Goals
Key Takeaways
Shares of Tvardi Therapeutics (TVRD - Free Report) nosedived 83.9% on Monday after the company provided a disappointing update following an analysis of preliminary data from a mid-stage study of its lead investigational candidate, TTI-101, to treat idiopathic pulmonary fibrosis (IPF). TTI-101 is TVRD’s oral small molecule therapy targeting STAT3.
Tvardi Therapeutics’ phase II REVERT IPF study evaluated TTI-101, either as a monotherapy or in combination with Boehringer Ingelheim’s Ofev (nintedanib), in IPF patients. The primary goals were to assess safety, pharmacokinetics and exploratory measures of lung function. A total of 88 patients were enrolled to receive either a 400/800 mg/day dose of the candidate or placebo, and stratified based on Ofev use, with 58% receiving concomitant therapy.
TVRD’s Phase II IPF Study Data in Detail
According to Tvardi Therapeutics’ preliminary data readout, the phase II REVERT IPF study did not achieve its intended objectives based on the safety and efficacy findings, including changes in Forced Vital Capacity (FVC), which is a crucial measurement in pulmonary function tests. Baseline characteristics were generally balanced across treatment groups, and TTI-101 therapy did not demonstrate a meaningful benefit over placebo. The placebo group had a slightly lower mean predicted FVC (70.1%) compared with the TTI-101 400 mg and 800 mg groups (74.1% and 81.1%, respectively).
Tvardi Therapeutics also reported that the study was not statistically powered to assess exploratory efficacy outcomes. The number of evaluable patients with at least one baseline and on-treatment FVC measurement declined over the 12-week duration in all study groups.
Year to date, TVRD stock has plunged 63.6% against the industry’s 7.3% growth.
Image Source: Zacks Investment Research
Furthermore, analysis of exploratory efficacy showed no statistically significant differences between TTI-101 and placebo. The proportion of patients achieving FVC improvement from baseline was comparable across all groups (41% for placebo, and 39% and 44% for the 400 mg and 800 mg cohorts, respectively). FVC changes overlapped substantially between arms, with high variability observed within each treatment group. Interestingly, the FVC decline in the placebo group was lower than expected relative to historical data, further contributing to the lack of differentiation between treatment arms.
Tvardi Therapeutics added that discontinuation rates varied notably across treatment groups, with fewer patients discontinuing in the placebo arm (10.3%) compared to the TTI-101 400 mg and 800 mg groups (56.7% and 62.1%, respectively). Most discontinuations in the TTI-101 arms were associated with gastrointestinal adverse events, particularly among patients who were also receiving Ofev.
TVRD’s Next Steps in the TTI-101 Development Process
Tvardi Therapeutics is currently conducting additional analysis of the phase II REVERT IPF study data to better understand the results and determine its next steps in the development of TTI-101 for IPF.
Apart from the IPF indication, the company is also currently evaluating TTI-101 in a separate phase II study for hepatocellular carcinoma. Its clinical-stage pipeline comprises another candidate, TTI-109, a next-generation STAT3 inhibitor, which is currently being evaluated in an early-stage healthy volunteer study. The company is reportedly on track to announce top-line data from both these studies in the first half of 2026.
Per Tvardi Therapeutics, TTI-109 is designed to build on TTI-101’s mechanism of action by serving as a more efficient STAT3-targeting agent, with the potential to enhance drug delivery and improve tolerability. Following completion of the TTI-109 study, the company plans to evaluate opportunities to expand into additional STAT3-driven indications.
Tvardi Therapeutics, Inc. Price and Consensus
Tvardi Therapeutics, Inc. price-consensus-chart | Tvardi Therapeutics, Inc. Quote
TVRD’s Zacks Rank & Stocks to Consider
Tvardi Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Alnylam Pharmaceuticals (ALNY - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Chemomab Therapeutics (CMMB - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Alnylam Pharmaceuticals’ 2025 earnings per share have increased from $3.35 to $3.98. Earnings per share estimates for 2026 have also increased from $8.95 to $9.61 during the same period. ALNY stock has surged 97.6% year to date.
Alnylam Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters while missing the same on the other two occasions, the average negative surprise being 8.29%.
In the past 60 days, estimates for Allogene Therapeutics’ 2025 loss per share have narrowed from $1.02 to 96 cents. Loss per share estimates for 2026 have narrowed from 98 cents to 86 cents during the same period. ALLO stock has lost 40.4% year to date.
Allogene Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 14.03%.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 53.6% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.