---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-158192"
form_type: "8-K"
ticker: "RNTX"
cik: "0001420565"
company_name: "Rein Therapeutics, Inc."
filed_at: "2025-07-11T23:59:59+00:00"
generated_at: "2026-05-18T06:53:51.524571+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Rein Therapeutics receives FDA clinical hold on LTI-03 Phase 2 trial; cites insufficient nonclinical safety data

## Summary
- FDA placed Phase 2 RENEW trial of LTI-03 on clinical hold on July 8, 2025 via formal letter.
- FDA cited no NOAEL and minimal mucus cell hyperplasia in 26-week rat study; requests new inhalation toxicity study.
- Company believes existing data supports safety, plans to work with FDA to resolve hold expeditiously.
- Board approved bylaw amendment lowering quorum requirement to 40% of shares outstanding.

## SEC filing metadata
- accession: 0001193125-25-158192
- form_type: 8-K
- ticker: RNTX
- cik: 0001420565
- company_name: Rein Therapeutics, Inc.
- filed_at: 2025-07-11T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 5.03, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1420565/000119312525158192/0001193125-25-158192-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1420565/000119312525158192/d83413d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-158192
- JSON: https://secwatch.observer/filing/0001193125-25-158192.json
- Plain text: https://secwatch.observer/filing/0001193125-25-158192.txt

## Key facts
- Governance Changes
  Rein Therapeutics, Inc.: Amended quorum requirement to 40% of outstanding shares entitled to vote at stockholder meetings (effective 2025-07-10).
  - Change: bylaw amendment
  - Effective: 2025-07-10
  source text: On July 10, 2025, the Board of Directors (the “Board”) of Rein Therapeutics, Inc. (the “Company”) approved an amendment to the Company’s Amended and Restated By-laws (as amended, the “By-laws”), effective immediately, to provide that forty percent (40%) of the shares of capital stock of the Company issued and outstanding and entitled to vote at the meeting, present in person, present by means of remote communication in a manner, if any, authorized by the Board in its sole discretion, or represented by proxy shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise provided by law, the Restated Certificate of Incorporation, as amended, or the By-laws.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1420565/000119312525158192/0001193125-25-158192-index.htm

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