PepGen (PEPG) said Monday it has received a Food and Drug Administration clinical hold notice for its investigational new drug application to initiate a phase 2 trial of PGN-EDO51, a potential treatment for Duchenne muscular dystrophy.
The regulator will send an official clinical hold letter within 30 days, the company said.
"We intend to work closely with the FDA to address their questions on our application to initiate [the trial] as expeditiously as possible," said Paul Streck, head of R&D of PepGen.
PepGen were down 23% in recent premarket trading.
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