regulatory
confidence high
sentiment negative
materiality 0.80
PepGen receives FDA clinical hold for Phase 2 DMD trial IND
PepGen Inc.
- FDA issued clinical hold for IND to initiate CONNECT2-EDO51 Phase 2 study of PGN-EDO51 in DMD patients.
- FDA to provide official clinical hold letter within 30 days; CONNECT2 remains open in the UK.
- Open-label CONNECT1-EDO51 study in Canada continues; 10 mg/kg cohort now fully enrolled.
- PepGen intends to work closely with FDA to address questions expeditiously.