regulatory
confidence high
sentiment negative
materiality 0.70
PepGen gets FDA clinical hold on CONNECT2 U.S. trial; Health Canada restricts dose escalation in CONNECT1
PepGen Inc.
- 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.