---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-046722"
form_type: "8-K"
ticker: "PEPG"
cik: "0001835597"
company_name: "PepGen Inc."
filed_at: "2023-09-06T23:59:59+00:00"
generated_at: "2026-06-10T23:34:22.636381+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# PepGen receives Health Canada clearance to begin Phase 1 study of PGN-EDODM1 in DM1; FDA grants Orphan Drug Designation

## Summary
- Health Canada issued No Objection Letter for CTA to start FREEDOM-DM1 Phase 1 trial of PGN-EDODM1 in myotonic dystrophy type 1.
- FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of DM1.
- Phase 1 study is a randomized, placebo-controlled, SAD study enrolling ~24 adults; dose escalation from 5 mg/kg to 10 mg/kg then 20 mg/kg.
- Initial results from the FREEDOM-DM1 study are expected in 2024.
- FDA clinical hold on US IND for PGN-EDODM1 remains; company continues working to resolve it.

## SEC filing metadata
- accession: 0000950170-23-046722
- form_type: 8-K
- ticker: PEPG
- cik: 0001835597
- company_name: PepGen Inc.
- filed_at: 2023-09-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1835597/000095017023046722/0000950170-23-046722-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835597/000095017023046722/pepg-20230906.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-046722
- JSON: https://secwatch.observer/filing/0000950170-23-046722.json
- Plain text: https://secwatch.observer/filing/0000950170-23-046722.txt

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