SRPT Stock Down After EMA Places Clinical Hold on DMD Gene Therapy [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
one-shot gene therapy for Duchenne muscular dystrophy (DMD). The therapy has been developed in collaboration with pharma giant Roche RHHBY. This hold has been placed in response to a patient's death post-treatment with Elevidys, which was reported last month. Though the death was due to acute liver failure (a known risk of Elevidys), Sarepta believes that the patient's recent CMV infection might have contributed to the outcome. Investigation is still ongoing. In a letter to the World Duchenne Organization, Roche mentioned that the companies are pausing enrollment and dosing of study participants in three studies evaluating the therapy at the EU study sites. This hold will remain ‘until the analysis into the cause of death is complete.' The paused studies include Sarepta-sponsored phase III ENVISION study (in boys aged 8-17 years), the Roche-sponsored phase II ENVOL study in infants and newborns, and Sarepta's early-stage study in boys aged 4 to 9 years with pre-existing antibodi
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