{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-210050","form_type":"8-K","ticker":"RNTX","cik":"0001420565","company_name":"Rein Therapeutics, Inc.","filed_at":"2025-09-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.950343+00:00","generated_at":"2026-05-17T05:57:47.306440+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA agrees MCH/H findings not dose-limiting for Rein Therapeutics' LTI-03 Phase 2 trial; CRL submission planned","bullets":["FDA confirmed MCH/H findings in GLP rat studies are not dose-limiting for proposed 24-week LTI-03 protocol at doses up to 10 mg/day in IPF patients.","FDA stated Complete Response Letter (CRL) need not include new GLP rat toxicity study; Rein will prepare CRL in coming weeks.","FDA recommended CRL include updated clinical safety, PK/PD data, augmented safety monitoring with spirometry, and DSMB unblinded reviews.","Clinical hold on U.S. Phase 2 RENEW trial (LTI-03) remains; company hopeful for timely release after CRL submission."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-210050","json":"https://secwatch.observer/filing/0001193125-25-210050.json","markdown":"https://secwatch.observer/filing/0001193125-25-210050.md","text":"https://secwatch.observer/filing/0001193125-25-210050.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1420565/000119312525210050/0001193125-25-210050-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1420565/000119312525210050/d902312d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:57:47.306440+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"}