PepGen clinical hold likely to be resolved quickly, says Leerink

PepGen (PEPG) announced that the FDA has placed a clinical hold on the Phase 2 CONNECT2-EDO51 study of PGN-EDO51 in Duchenne muscular dystrophy, while the open-label Phase 2 CONNECT1-EDO51 study continues excluding the U.S. Leerink tells investors in a research note. The firm, which reiterates an Outperform rating, says management does not what the hold is connected to at this time and are waiting for the full letter for details, and notes that the news is reminiscent of what happened to PepGen when they initiated U.S. sites in the Phase 1 FREEDOM-DM1 study of PGN-EDODM1 in myotonic dystrophy type 1. Leerink is optimistic PepGen will be able to resolve the hold relatively quickly.