By Colin Kellaher
PepGen shares fell sharply in premarket trading Monday after the clinical-stage biotechnology company said the Food and Drug Administration placed a hold on a planned mid-stage study of its PGN-EDO51 drug candidate.
PepGen said it has received a clinical-hold notice from the FDA related to the Phase 2 study the neuromuscular genetic disease Duchenne muscular dystrophy, adding that the agency indicated it will provide an official letter within 30 days.
Shares of the Boston company, which closed Friday at $4.68, were recently down 25% at $3.53 in premarket trading.
According to the FDA's website, subjects can't be given an investigational drug when a proposed study is placed on clinical hold. The agency lists several potential reasons for putting an investigational new drug application on hold, including the possibility that human subjects "would be exposed to an unreasonable and significant risk of illness or injury," or that the application doesn't contain enough information to assess the risks to subjects of the proposed studies.
PepGen said the Phase 2 ascending-dose study is open in the U.K., and that it will work closely with the FDA to address any questions.
The company said a separate Phase 2 ascending-dose study of PGN-EDO51 continues as planned in Canada, and that it has completed enrollment of the 10 mg/kg dose cohort.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 16, 2024 08:29 ET (13:29 GMT)
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