# United Therapeutics (UTHR) announced that the U.S. FDA has granted clearance to proceed with a clinical study of its investigational UHeart derived from a pig with 10 gene edits.

*biotech · news · 2026-05-15 · Markets Insider*

## Key points

- The FDA cleared United Therapeutics to begin a clinical trial of its genetically engineered pig heart, UHeart.
- The UHeart has 10 specific gene edits to enable human transplantation.
- The EXPRESS study will initially enroll up to two participants for UHeart xenotransplantation.
- FDA review of initial safety and efficacy data will determine if the trial can expand further.

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. Claim 55% Off TipRanks

**Countries:** United States

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