FDA Lifts Hold on PepGen's New Drug Application for Dystrophy Treatment

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 [e-mail]

(END) Dow Jones Newswires

10-12-23 0737ET