Rein Therapeutics shares surge 14.18% after-hours as FDA lifts clinical hold on LTI-03 IPF trial, enabling U.S. enrollment resumption.

Rein Therapeutics surged 14.18% in after-hours trading following the FDA’s clearance to resume its Phase 2 RENEW trial of LTI-03 for idiopathic pulmonary fibrosis. The agency lifted a full clinical hold after reviewing the company’s response to prior concerns, enabling U.S. enrollment to restart at 20 sites by late 2025 or early 2026. The trial, part of a global study across 50+ sites, aims to evaluate LTI-03’s safety, tolerability, and efficacy in 120 patients, with initial topline data expected in Q3 2026. Positive early data suggesting the drug may slow fibrosis and promote lung healing, coupled with the resolution of regulatory hurdles, bolstered investor confidence. The FDA’s endorsement underscores progress in LTI-03’s development as a potential first-in-class therapy for IPF, a high-unmet-need indication with a projected $11 billion market by 2031.