{"schema_version":"secwatch.filing_event.v1","accession":"0001689375-25-000004","form_type":"8-K","ticker":"TRDA","cik":"0001689375","company_name":"Entrada Therapeutics, Inc.","filed_at":"2025-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.452385+00:00","generated_at":"2026-05-26T06:00:33.064016+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA lifts clinical hold on Entrada's ENTR-601-44 for DMD Phase 1b study","bullets":["FDA authorized ELEVATE-44-102, a Phase 1b multiple ascending dose study of ENTR-601-44 in adults with DMD amenable to exon 44 skipping.","Study targets ~32 non-ambulatory and ambulatory patients; doses from 0.16 to 1.28 mg/kg every six weeks.","Company also received UK MHRA authorization for ELEVATE-44-201; global program now covers pediatric and adult patients.","Plans to initiate enrollment in first half of 2026 with seamless transition to open-label extension.","CEO cites strength of Phase 1 safety/target engagement data and unmet need in adults living with Duchenne."],"urls":{"canonical":"https://secwatch.observer/filing/0001689375-25-000004","json":"https://secwatch.observer/filing/0001689375-25-000004.json","markdown":"https://secwatch.observer/filing/0001689375-25-000004.md","text":"https://secwatch.observer/filing/0001689375-25-000004.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689375/000168937525000004/0001689375-25-000004-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689375/000168937525000004/trda-20250224.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T06:00:33.064016+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"}