---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-139950"
form_type: "8-K"
ticker: "RNTX"
cik: "0001420565"
company_name: "Rein Therapeutics, Inc."
filed_at: "2025-06-12T23:59:59+00:00"
generated_at: "2026-05-19T10:31:16.936740+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Rein Therapeutics pauses US enrollment in Phase 2 RENEW trial due to FDA clinical hold

## Summary
- FDA placed clinical hold on Phase 2 RENEW trial of LTI-03 on June 10, 2025; US enrollment and dosing paused.
- Rein is working with FDA to address non-clinical requests to resume US enrollment.
- Trial continues with site initiation and patient enrollment in Australia, UK, and Europe.
- No drug-related serious adverse events reported across all LTI-03 studies.
- LTI-03 is a novel Caveolin-1-related peptide for idiopathic pulmonary fibrosis (IPF).

## SEC filing metadata
- accession: 0001193125-25-139950
- form_type: 8-K
- ticker: RNTX
- cik: 0001420565
- company_name: Rein Therapeutics, Inc.
- filed_at: 2025-06-12T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1420565/000119312525139950/0001193125-25-139950-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1420565/000119312525139950/d940498d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-139950
- JSON: https://secwatch.observer/filing/0001193125-25-139950.json
- Plain text: https://secwatch.observer/filing/0001193125-25-139950.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.