---
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"
generated_at: "2026-05-27T07:15:12.896346+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# PepGen gets FDA clinical hold on CONNECT2 U.S. trial; Health Canada restricts dose escalation in CONNECT1

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-010515
- JSON: https://secwatch.observer/filing/0000950170-25-010515.json
- Plain text: https://secwatch.observer/filing/0000950170-25-010515.txt

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