{"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","discovered_at":"2026-05-14T18:02:48.244328+00:00","generated_at":"2026-05-19T10:31:16.936740+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Rein Therapeutics pauses US enrollment in Phase 2 RENEW trial due to FDA clinical hold","bullets":["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)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-139950","json":"https://secwatch.observer/filing/0001193125-25-139950.json","markdown":"https://secwatch.observer/filing/0001193125-25-139950.md","text":"https://secwatch.observer/filing/0001193125-25-139950.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T10:31:16.936740+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}