Earnings summaries and quarterly performance for Rein Therapeutics.
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Rein Therapeutics receives FDA clearance to resume Phase 2 trial of LTI-03
RNTX
New Projects/Investments
- Rein Therapeutics received FDA clearance on November 3, 2025, to resume its U.S. Phase 2 trial of LTI-03 for Idiopathic Pulmonary Fibrosis (IPF).
- The company expects to restart U.S. patient enrollment in late 2025 or early 2026 across approximately 20 clinical sites.
- Initial topline data from the trial is expected in Q3 2026.
Nov 3, 2025, 12:45 PM
Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03
RNTX
New Projects/Investments
Product Launch
- Rein Therapeutics, Inc. (RNTX) has received authorization from the European Medicines Agency (EMA) to initiate its Phase 2 "RENEW" clinical trial for its lead candidate, LTI-03, which is designed to treat idiopathic pulmonary fibrosis (IPF).
- The EMA approval covers clinical trial sites in Germany and Poland, building on previous regulatory clearance from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA).
- The RENEW trial is a randomized, double-blind, placebo-controlled Phase 2 study that plans to enroll up to 120 patients globally to assess the safety, tolerability, and efficacy of LTI-03 over a 24-week treatment duration.
Oct 9, 2025, 11:45 AM
Rein Therapeutics Receives Favorable FDA Feedback on LTI-03 Clinical Hold
RNTX
New Projects/Investments
- Rein Therapeutics, Inc. (RNTX) received additional communication from the FDA on September 16, 2025, regarding the clinical hold on its U.S. Phase 2 RENEW clinical trial of LTI-03.
- The FDA agreed that the MCH/H findings in GLP rat studies are not dose-limiting for the proposed clinical protocol of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients.
- The FDA recommended the Company prepare a Complete Response Letter (CRL) to address safety concerns, explicitly stating that data from a new GLP toxicity study in rats is not required.
- Rein Therapeutics is currently preparing the CRL and anticipates submitting it in the coming weeks, with the goal of achieving a timely release of the clinical hold.
Sep 22, 2025, 12:00 PM
Quarterly earnings call transcripts for Rein Therapeutics.
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