{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-052999","form_type":"8-K","ticker":"PEPG","cik":"0001835597","company_name":"PepGen Inc.","filed_at":"2023-10-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.894423+00:00","generated_at":"2026-06-10T00:57:15.800391+00:00","sec_items":["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 PepGen's DM1 program; US Phase 1 trial to begin","bullets":["FDA cleared IND for FREEDOM-DM1 Phase 1 study of PGN-EDODM1 in DM1 patients in the US.","Target dose levels in the study: 5 mg/kg, 10 mg/kg, and 20 mg/kg.","Proof-of-concept data (safety, transcript splicing, clinical outcomes) at 5 mg/kg expected in 2024.","CONNECT1-EDO51 DMD study proof-of-concept data (exon skipping, dystrophin) at 5 mg/kg expected mid-2024.","Cash and equivalents expected to fund operations into 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-052999","json":"https://secwatch.observer/filing/0000950170-23-052999.json","markdown":"https://secwatch.observer/filing/0000950170-23-052999.md","text":"https://secwatch.observer/filing/0000950170-23-052999.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835597/000095017023052999/0000950170-23-052999-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835597/000095017023052999/pepg-20231012.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T00:57:15.800391+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"}