FDA Lifts Hold on PepGen's New Drug Application for Dystrophy Treatment
October 12 2023 - 7:52AM
Dow Jones News
By Dean Seal
Federal regulators have lifted a clinical hold on PepGen's
investigational new drug application for a myotonic dystrophy
treatment.
The clinical-stage biotechnology company said Thursday the U.S.
Food and Drug Administration has cleared it to launch a phase 1
study of the treatment, PGN-EDODM1, in U.S.-based patients with
myotonic dystrophy type 1.
PepGen worked closely with the FDA to resolve questions about
the treatment, Chief Executive James McArthur said.
The company expects to obtain proof-of-concept data and safety
data for the study patients in 2024.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
October 12, 2023 07:37 ET (11:37 GMT)
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