Sarepta (SRPT) Therapeutics announced that the FDA has approved dosing in Cohort 8 of ENDEAVOR. The purpose of Cohort 8 is to evaluate the use of an enhanced immunosuppressive regimen as part of treatment with Elevidys for non-ambulant individuals with Duchenne muscular dystrophy. Data from Cohort 8 will be used to determine whether administering sirolimus prior to and after Elevidys infusion can help reduce acute liver injury. The cohort will enroll approximately 25 participants in the U.S. who are non-ambulatory. The company plans to initiate Cohort 8 by the end of this year, and plans to complete primary data endpoint collection in the second half of 2026.
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