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PepGen cleared by FDA to begin study of muscular dystrophy drug

October 12, 2023

The FDA has shown caution with companies developing RNA treatments for neuromuscular conditions. Dyne Therapeutics, Sarepta Therapeutics, Avidity Biosciences and Entrada Therapeutics have all faced delays in their work amid partial or full clinical holds.

PepGen appears to have resolved its issues with regulators relatively quickly, which is an encouraging sign for the program, Stifel analyst Paul Matteis wrote in a note to investors. He called the stock “very cheap,” given that the company is on track to provide proof-of-concept data not only for the DM1 drug but also for another experimental therapy for Duchenne muscular dystrophy next year.

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