{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-136389","form_type":"8-K","ticker":"PEPG","cik":"0001835597","company_name":"PepGen Inc.","filed_at":"2024-12-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.928788+00:00","generated_at":"2026-05-29T03:05:16.560464+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"PepGen receives FDA clinical hold for Phase 2 DMD trial IND","bullets":["FDA issued clinical hold for IND to initiate CONNECT2-EDO51 Phase 2 study of PGN-EDO51 in DMD patients.","FDA to provide official clinical hold letter within 30 days; CONNECT2 remains open in the UK.","Open-label CONNECT1-EDO51 study in Canada continues; 10 mg/kg cohort now fully enrolled.","PepGen intends to work closely with FDA to address questions expeditiously."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-136389","json":"https://secwatch.observer/filing/0000950170-24-136389.json","markdown":"https://secwatch.observer/filing/0000950170-24-136389.md","text":"https://secwatch.observer/filing/0000950170-24-136389.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835597/000095017024136389/0000950170-24-136389-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835597/000095017024136389/pepg-20241216.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T03:05:16.560464+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"}