After Setbacks, Confidence Grows In Likely Success For Sarepta’s Duchenne Gene Therapy
Contrasts With Pfizer Safety Concerns
CEO tells J.P. Morgan conference that he is confident the pivotal EMBARK study can be completed in 2022 with regulatory filing in 2023.
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The death in Pfizer’s Phase I study could reflect wider safety issues for AAV-based gene therapy and could spur intervention from regulators in 2022.
Any time advantage Sarepta's Duchenne muscular dystrophy gene therapy may have had over rivals, notably Pfizer, has disappeared after SRP-9001 failed to significantly improve muscle function in a closely watched trial.