---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-016804"
form_type: "8-K"
ticker: "PEPG"
cik: "0001835597"
company_name: "PepGen Inc."
filed_at: "2024-02-20T23:59:59+00:00"
generated_at: "2026-06-05T23:21:18.068381+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# PepGen gets FDA Fast Track for PGN-EDODM1 in DM1; Phase 1 data due 2024

## Summary
- FDA granted Fast Track designation for PGN-EDODM1 targeting myotonic dystrophy type 1 (DM1).
- No approved therapies target root cause of DM1; PGN-EDODM1 aims to be disease-modifying.
- Ongoing FREEDOM-DM1 Phase 1 trial (NCT06204809); preliminary data expected in 2024.
- PGN-EDODM1 previously received FDA Orphan Drug Designation in September 2023.

## SEC filing metadata
- accession: 0000950170-24-016804
- form_type: 8-K
- ticker: PEPG
- cik: 0001835597
- company_name: PepGen Inc.
- filed_at: 2024-02-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1835597/000095017024016804/0000950170-24-016804-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835597/000095017024016804/pepg-20240220.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-016804
- JSON: https://secwatch.observer/filing/0000950170-24-016804.json
- Plain text: https://secwatch.observer/filing/0000950170-24-016804.txt

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