United Therapeutics cleared by FDA to proceed with UHeart clinical trial

United Therapeutics (UTHR) announced that the U.S. FDA has granted clearance under the company’s Investigational New Drug application to proceed with a clinical study of its investigational UHeart derived from a pig with 10 gene edits. The study, known as EXPRESS, will enroll an initial cohort of up to two participants. United Therapeutics will provide the FDA with safety and efficacy data from the first UHeart xenotransplant recipient in the study before enrolling a second participant. Following FDA review of available safety and efficacy data from the initial two transplants, the study may then be further expanded, with the intent to support a Biologics License Application with the FDA.