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

Rein Therapeutics, Inc.

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.

Key facts

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Governance Changes SEC 8-K Item 5.03/5.05/5.06 confidence 0.9

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

Exact text from the filing

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.

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Rein Therapeutics, Inc. filing history →

Source: SEC EDGAR

accession 0001193125-25-158192

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