TVRD Stock Plunges 84% After Phase II Fibrosis Study Misses Key Goals

Core Insights - Tvardi Therapeutics (TVRD) shares fell 83.9% following disappointing preliminary data from a mid-stage study of TTI-101 for idiopathic pulmonary fibrosis (IPF) [1][5] - The phase II REVERT IPF study did not meet its primary objectives regarding safety and efficacy, particularly in lung function measurements [3][4] Study Overview - The phase II REVERT IPF study evaluated TTI-101 as a monotherapy or in combination with Boehringer Ingelheim's Ofev, enrolling 88 patients [2] - The primary goals included assessing safety, pharmacokinetics, and exploratory lung function measures [2] Study Results - Preliminary data indicated TTI-101 did not show significant improvement in Forced Vital Capacity (FVC) compared to placebo, with FVC changes overlapping between treatment arms [3][7] - The placebo group had a mean predicted FVC of 70.1%, while the TTI-101 groups had 74.1% and 81.1% for 400 mg and 800 mg doses, respectively [3] - Discontinuation rates were notably higher in TTI-101 groups (56.7% and 62.1%) compared to the placebo group (10.3%), primarily due to gastrointestinal side effects [8] Future Directions - Tvardi Therapeutics is conducting further analysis of the REVERT IPF study data to determine next steps for TTI-101 [9] - The company is also evaluating TTI-101 in a separate phase II study for hepatocellular carcinoma and plans to announce top-line data from both studies in the first half of 2026 [10] Pipeline Developments - TTI-109, a next-generation STAT3 inhibitor, is in early-stage evaluation, aiming to enhance drug delivery and tolerability compared to TTI-101 [11]