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United Therapeutics wins FDA clearance for UHeart xenotransplant trial

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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. The Phase 1/2/3 EXPRESS study starts with up to 2 participants.

United Therapeutics received FDA clearance under an Investigational New Drug application to begin a clinical trial of its pig-derived UHeart xenotransplant. The Phase 1/2/3 EXPRESS study starts with up to 2 participants. FDA will review safety and efficacy data from the first transplant before a second is enrolled.

The program is structured to support a potential Biologics License Application if early results support expansion.

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References

  1. United Therapeutics wins FDA clearance for UHeart xenotransplant trial · sahmcapital.com
  2. United Therapeutics (UTHR) Receives FDA Approval for UHeart Clinical Study - GuruFocus · gurufocus.com
  3. FDA Approval Of ENHANCE Heart Trial Reshapes TransMedics Growth Story · simplywall.st
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