Why Is Rein Therapeutics Stock Trading Higher On Monday?

Core Insights - Rein Therapeutics' stock is experiencing a significant increase following the FDA's decision to lift the full clinical hold on its Phase 2 RENEW trial for LTI-03 in patients with idiopathic pulmonary fibrosis (IPF) [1][2][4] Group 1: FDA Decision and Trial Resumption - The FDA confirmed that the concerns regarding Study LTI-03-2001 have been fully resolved, allowing the trial to proceed [2] - Rein Therapeutics plans to resume patient recruitment in late 2025 or early 2026 across approximately 20 clinical sites in the U.S. [2] - The company had previously paused enrollment and dosing in June 2023 to address non-clinical requests that led to the clinical hold [2] Group 2: Trial Details and Expectations - The RENEW trial aims to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients with IPF, with key secondary endpoints including changes in lung function and imaging-based measures of fibrosis progression [3] - The U.S. enrollment is part of a broader global study that includes around 30 additional sites in the UK, Germany, Poland, and Australia [3] - Initial topline data from the trial is expected in the third quarter of 2026 [3] Group 3: Stock Performance - Following the FDA announcement, RNTX stock rose by 16.29%, reaching a price of $1.82 [4]