---
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"
generated_at: "2026-05-29T03:05:16.560464+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# PepGen receives FDA clinical hold for Phase 2 DMD trial IND

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-136389
- JSON: https://secwatch.observer/filing/0000950170-24-136389.json
- Plain text: https://secwatch.observer/filing/0000950170-24-136389.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.