Sarepta and Roche aim to resume paused Elevidys trials following patient death [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
Three European studies, notably the Envol study (NCT06128564); the Envision study (NCT05881408); and study 104 (NCT06241950), were paused on request by the European Union (EU) reference member country authorities while the independent data monitoring committee (DMC) met to review the adverse event (AE). Roche is heading up two of the studies, the Phase II Envol study, which is investigating Elevidys in babies and newborns; and the Phase III Envision, which is evaluating the gene therapy in boys aged eight to 17 years. Sarepta is leading Study 104, a Phase I study evaluating Elevidys in boys aged four to nine years with pre-existing antibodies to a particular serotype. The independent DMC met on 3 April, a day after the suspensions were announced, and agreed that based on the totality of evidence and the overall benefit-risk profile, dosing in the paused trials could continue without changes to the study protocols. The companies will submit this data, which it hopes will allow t
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