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PepGen has received a clinical hold notice from the FDA regarding its Investigational New Drug (IND) application in Duchenne amenable to skipping exon 51, and will be unable to initiate their Phase 2 CONNECT2-EDO51 trial in the U.S, until that is resolved. PepGen is currently conducting an open-label CONNECT1-EDO51 multiple ascending dose study in Canada, and the CONNECT2 trial is already open in the United Kingdom.
Read the full press release HERE