{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-024350","form_type":"8-K","ticker":"PEPG","cik":"0001835597","company_name":"PepGen Inc.","filed_at":"2024-03-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:25.863510+00:00","generated_at":"2026-06-05T04:58:51.295238+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"PepGen gets UK MHRA clearance to start Phase 2 trial of PGN-EDO51 for DMD","bullets":["MHRA authorized CTA for CONNECT2-EDO51 Phase 2 trial of PGN-EDO51 in DMD patients amenable to exon 51 skipping.","Trial is randomized, placebo-controlled, multiple ascending dose, enrolling ~20 boys/young men aged ≥6 years.","PGN-EDO51 is an oligonucleotide therapy; data from CONNECT1 (ongoing Phase 1) plus CONNECT2 could support accelerated approval.","Starting dose 5 mg/kg escalating to 10 mg/kg and potentially higher; muscle biopsies at baseline and week 25 to assess exon skipping and dystrophin production.","Participants have option for open-label extension after 24-week treatment period."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-024350","json":"https://secwatch.observer/filing/0000950170-24-024350.json","markdown":"https://secwatch.observer/filing/0000950170-24-024350.md","text":"https://secwatch.observer/filing/0000950170-24-024350.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835597/000095017024024350/0000950170-24-024350-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835597/000095017024024350/pepg-20240304.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T04:58:51.295238+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"}