---
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"
generated_at: "2026-06-14T02:17:56.321439+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# PepGen withdraws PGN-EDODM1 Phase 1 timeline guidance pending FDA clinical hold

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-027696
- JSON: https://secwatch.observer/filing/0000950170-23-027696.json
- Plain text: https://secwatch.observer/filing/0000950170-23-027696.txt

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