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Investing.com -- Tvardi Therapeutics (NASDAQ:TVRD) stock plunged 30% after the company reported disappointing preliminary data from its Phase 2 REVERT trial evaluating TTI-101 in idiopathic pulmonary fibrosis (IPF).
The clinical-stage biopharmaceutical company announced that the study did not meet its goals after reviewing preliminary safety data and exploratory efficacy results. The randomized, double-blind, placebo-controlled trial evaluated TTI-101 alone or in combination with nintedanib in 88 IPF patients.
High discontinuation rates plagued the treatment arms, with 56.7% of patients in the 400mg group and 62.1% in the 800mg group dropping out, compared to just 10.3% in the placebo group. These discontinuations were primarily driven by gastrointestinal adverse events, particularly among patients receiving concurrent nintedanib therapy.
The preliminary analysis showed no statistically significant differences between the placebo and treatment arms. At the 12-week timepoint, patients receiving placebo showed a mean FVC decline of 22.2 mL, while those on 400mg and 800mg of TTI-101 declined by 61.1 mL and 102.8 mL, respectively.
"In the aggregate, we did not observe a benefit of TTI-101 treatment in this IPF study," said Imran Alibhai, CEO of Tvardi. The company noted that the placebo group’s performance was better than expected compared to historical controls, further complicating data interpretation.
Despite this setback, Tvardi remains on track to report preliminary data for its next-generation STAT3 inhibitor, TTI-109, and from a Phase 2 trial of TTI-101 in hepatocellular carcinoma in the first half of 2026. The company reported $41.0 million in cash and investments as of June 30, 2025, which it expects will fund operations into the fourth quarter of 2026.
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