United Therapeutics (UTHR) announced that the FDA has cleared its investigational new drug application to initiate a clinical study of the company’s investigational UKidney derived from a 10 gene-edited source pig. The study will enroll an initial cohort of six end-stage renal disease patients, expanding to up to 50 participants, and is intended to support a biologics license application with the FDA. United Therapeutics expects the first xenotransplant in this trial to be performed around mid-year 2025.
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