Rein Therapeutics ( RNTX ) stock is trading higher on Monday, with a session volume of 41.2 million compared to its average volume of 162.67 thousand, according to data from Benzinga Pro.

What Happened: The U.S. Food and Drug Administration (FDA) on Monday lifted the full clinical hold on the company’s Phase 2 RENEW trial of LTI-03 in patients with idiopathic pulmonary fibrosis (IPF).

The FDA’s decision follows a review of Rein’s submission, which addressed all of the agency’s concerns.

The agency confirmed that Study LTI-03-2001 may proceed and that any prior Full Clinical Hold concerns have been fully resolved.

Rein expects to resume patient recruitment in late 2025 or early 2026 across approximately 20 U.S. clinical sites.

In June, Rein Therapeutics ( RNTX ) paused enrollment and patient dosing for its Phase 2 RENEW trial of LTI-03 to address its non-clinical requests in order to remove a clinical hold, which was placed on the study on June 10.

Next Steps: The U.S. enrollment complements Rein’s broader global RENEW study, which includes approximately 30 additional sites in the United Kingdom, Germany, Poland, and Australia.

The trial is designed to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients with IPF.

Key secondary endpoints include changes in lung function (FVC) and imaging-based measures of fibrosis progression.

Initial topline data is expected in the third quarter of 2026.

Price Action: RNTX stock is up 16.29% at $1.82 at the last check on Monday.

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