UTHR News & Events

United Therapeutics Corporation announced that the New England Journal of Medicine has published the full results of its TETON-1 study, as well as combined analyses of its TETON-1 and TETON-2 studies, evaluating the use of nebulized Tyvaso for the treatment of IPF. A summary of the publication was also presented today during a symposium at the annual meeting of the American Thoracic Society International Conference in Orlando. The use of nebulized Tyvaso for IPF has not been approved by the U.S. Food and Drug Administration and remains investigational for IPF. The results of TETON-1 were also presented at ATS during the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session on Sunday, May 17. Combined results from TETON-1 and TETON-2 were presented today during an oral session at ATS. TETON-1 met its primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant improvement in absolute FVC relative to placebo from baseline to week 52 in an IPF population broadly treated with background therapy. The median change in FVC at week 52 was -43.3 mL in the nebulized Tyvaso group and -196.2 mL in the placebo group; between-group difference was 130.1 mL.

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.