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Sarepta Announces Approval to Begin ENDEAVOR Cohort 8 to Evaluate Enhanced Immunosuppression Regimen as Part of ELEVIDYS Gene Therapy for Non-Ambulant Individuals with Duchenne

Sarepta Therapeutics, Inc. (SRPT) 
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm Check Earnings Report
Company Research Source: Business Wire
Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to begin before the end of the yearThe enhanced immunosuppressive regimen is designed to mitigate the risk of acute liver injury (ALI) and acute liver failure (ALF) associated with AAV gene therapyDecisions regarding resuming commercial dosing for this population will be made in collaboration with FDA after reviewing study data CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved dosing in Cohort 8 of ENDEAVOR (Study 9001-103). The purpose of Cohort 8 is to evaluate the use of an enhanced immunosuppressive regimen as part of treatment with ELEVIDYS (delandistrogene moxeparvovec-rokl) for non-ambulant individuals with Duchenne muscular dystrophy.Data from Cohort 8 will be used to de Show less Read more
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