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United Therapeutics announces FDA clearance of UKidney NDA

United Therapeutics announces FDA clearance of UKidney NDA

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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