{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-027696","form_type":"8-K","ticker":"PEPG","cik":"0001835597","company_name":"PepGen Inc.","filed_at":"2023-06-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:41.022189+00:00","generated_at":"2026-06-14T02:17:56.321439+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"PepGen withdraws PGN-EDODM1 Phase 1 timeline guidance pending FDA clinical hold","bullets":["Withdrawing prior guidance to initiate a Phase 1 study of PGN-EDODM1 in DM1 in H1 2023.","Awaiting official clinical hold letter from FDA; pausing additional regulatory filings to address the hold.","CEO committed to working with FDA to lift the hold and start study as quickly as feasible.","Company remains focused on advancing Phase 2 CONNECT1-EDO51 study in Duchenne muscular dystrophy, cleared by Health Canada in May 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-027696","json":"https://secwatch.observer/filing/0000950170-23-027696.json","markdown":"https://secwatch.observer/filing/0000950170-23-027696.md","text":"https://secwatch.observer/filing/0000950170-23-027696.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835597/000095017023027696/0000950170-23-027696-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835597/000095017023027696/pepg-20230613.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T02:17:56.321439+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"}