UTHR News & Events

United Therapeutics 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.

Varda Space Industries announced a collaboration with United Therapeutics to explore the use of microgravity to develop improved formulations of treatments for rare pulmonary disease. Through the collaboration, Varda and United Therapeutics will conduct pharmaceutical processing of small molecule medicines for pulmonary disease aboard Varda's orbital manufacturing and reentry platform during multiple missions to low Earth orbit. The first compounds to be analyzed onboard Varda spacecraft will likely be focused on therapies for patients living with life-threatening pulmonary diseases.