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Sarepta, Roche Pause Trials After Patient Death

4/3/2025

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Summary

Story summary

Sarepta and Roche have halted three clinical trials of their Duchenne muscular dystrophy gene therapy, Elevidys, in Europe following a tragic patient death from acute liver failure. The European Medicines Agency has mandated this pause for safety investigations, yet U.S. trials continue, with analysts predicting only slight delays in regulatory reviews.

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Story summary

Sarepta and Roche have halted three clinical trials of their Duchenne muscular dystrophy gene therapy, Elevidys, in Europe following a tragic patient death from acute liver failure. The European Medicines Agency has mandated this pause for safety investigations, yet U.S. trials continue, with analysts predicting only slight delays in regulatory reviews.