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RNTX Rein Therapeutics

Rein Therapeutics Inc is a clinical stage biopharmaceutical company focused on developing novel therapies for the treatment of orphan pulmonary and fibrosis indications with no approved or limited effective treatments. Its pipeline includes: LTI-03, a peptide, for placebo-controlled safety, tolerability, and pharmacody…

Assets on file: LTI-03

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September 2027

Sep 2027

Sep 30, 2027

in 334 days

RNTXRein Therapeutics

LTI-03: Phase 2 trial NCT06968845 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

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Decision-gradeMaterialNotableMinor

Oct 16, 2026

03:24 PM

RNTXRein Therapeutics

LTI-03 · NCT06968845 registry update

countries: {'total_sites': 36, 'us_sites': 19} → {'total_sites': 48, 'us_sites': 20}

Trial registry changeClinicalTrials.gov

Sep 22, 2025

12:00 PM

RNTXRein Therapeutics

Rein Therapeutics receives FDA feedback on LTI-03 clinical hold

FDA reviewed supplemental nonclinical data and confirmed MCH/H findings are not dose-limiting for the 24-week Phase 2 RENEW protocol at doses up to 10 mg/day. Company was advised to submit a CRL addressing safety concerns without new GLP rat toxicity studies; CRL preparation is underway with submission expected in the next few weeks.

Trial registry changeSEC 8-K Open record