FDA Halts PepGen's Duchenne Muscular Dystrophy Trial Amid Concerns
The FDA has halted the U.S. Phase II trial of PepGen’s Duchenne muscular dystrophy treatment, PGN-EDO51, known as the CONNECT2-EDO51 trial[1][2]. Despite this setback, the trial remains active in the U.K. and is proceeding with enrollments in Canada[1]. The pause by the FDA comes amid concerns such as mild and asymptomatic hypomagnesemia in two patients[1], leading to a significant drop in PepGen’s shares[2]. PepGen, however, remains committed to resolving the issue and continuing collaboration with the FDA to navigate these regulatory hurdles[2].
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What specific safety concerns led the FDA to place a hold on the Phase II trial of PGN-EDO51 for Duchenne muscular dystrophy?
How is PepGen planning to address the FDA's concerns in order to resume the Phase II trial in the U.S.?
What impact has the FDA's halt on the PGN-EDO51 trial had on PepGen's financial status and investor confidence?
How do the international trials in the U.K. and Canada differ from those in the U.S. regarding PGN-EDO51 for Duchenne muscular dystrophy?
What precedent might the resolution of this FDA hold set for other pharmaceutical companies facing similar regulatory challenges with innovative therapies?