United Therapeutics wins FDA clearance for UHeart xenotransplant trial

United Therapeutics Corporation

United Therapeutics Corporation

UTHR

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  • United Therapeutics received FDA clearance under an Investigational New Drug application to begin a clinical trial of its pig-derived UHeart xenotransplant.
  • Phase 1/2/3 EXPRESS study starts with up to 2 participants; FDA will review safety and efficacy data from first transplant before a second is enrolled.
  • Program structured to support a potential Biologics License Application if early results support expansion.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. United Therapeutics Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 202605151800BIZWIRE_USPR_____20260515_BW765117) on May 15, 2026, and is solely responsible for the information contained therein.

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