Rein Therapeutics shares surge 22.39% after-hours as FDA clears Phase 2 IPF trial resumption.

Tuesday, Nov 4, 2025 5:42 pm ET1min read
Rein Therapeutics surged 22.39% in after-hours trading following FDA 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 responses to prior concerns, enabling patient enrollment to restart in late 2025 or early 2026. This milestone validates progress in developing LTI-03, a potential disease-modifying therapy targeting fibrosis and lung repair, and aligns with the company’s strategy to address unmet needs in orphan pulmonary diseases. The news reinforced investor confidence in the trial’s potential to advance LTI-03 toward commercialization, with topline data expected in Q3 2026.

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