{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-010515","form_type":"8-K","ticker":"PEPG","cik":"0001835597","company_name":"PepGen Inc.","filed_at":"2025-01-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.175006+00:00","generated_at":"2026-05-27T07:15:12.896346+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"PepGen gets FDA clinical hold on CONNECT2 U.S. trial; Health Canada restricts dose escalation in CONNECT1","bullets":["10 mg/kg cohort fully enrolled (n=4); data expected year-end 2025.","One participant had eGFR reduction; dosing paused, eGFR improving.","Health Canada allows continued dosing at current levels but requests additional info before escalation.","FDA placed clinical hold on U.S. CONNECT2 trial; company working to address agency questions.","All treatment-related adverse events mild per Jan 23, 2025 update by CMO Paul Streck."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-010515","json":"https://secwatch.observer/filing/0000950170-25-010515.json","markdown":"https://secwatch.observer/filing/0000950170-25-010515.md","text":"https://secwatch.observer/filing/0000950170-25-010515.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1835597/000095017025010515/0000950170-25-010515-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1835597/000095017025010515/pepg-20250129.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T07:15:12.896346+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"}