FDA lifts clinical hold on Rein Therapeutics' Phase 2 trial of LTI-03 for IPF

Rein Therapeutics, Inc.

FDA lifted full clinical hold after Rein's Complete Response submission; agency confirmed all concerns resolved.
Company expects to resume U.S. patient enrollment in late 2025 or early 2026 across ~20 clinical sites.
Global Phase 2 RENEW trial to enroll up to 120 IPF patients; topline data expected in Q3 2026.
LTI-03 aims to slow fibrosis and promote lung repair, per CEO Brian Windsor.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.