United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the opening of its third Designated Pathogen-Free (DPF) facility, The Dr. Bartley P. Griffith and Dr. Robert A. Montgomery Xenograft Production Facility, in Houston, Texas.

United Therapeutics opened its first DPF facility in Christiansburg, Va. in 2024 to produce xenografts for ongoing clinical trials. The company celebrated the opening of its second facility, The Thomas E. Starzl Xenograft Production Facility, in Stewartville, Minn. on August 12, 2026. The two new facilities in Stewartville and Houston are designed to enable United Therapeutics to scale commercial production of its xeno-organs following approval of these products. All three facilities are crucial for advancing the company’s organ manufacturing program.

These facilities are a feat of biotechnology engineering, requiring a strictly controlled, biosecure barrier environment, including air filtration, filtered water, filtered feed supplies, and state-of-the-art decontamination entryways. They include hundreds of miles of carefully calibrated air and water conduits to support the transplantability of the final xenograft products and to help prevent contamination from pathogens. United Therapeutics also installed solar arrays on the remaining land for all three facilities, allowing them to offset a significant portion of their energy use with solar power.

“Every day, people with end-stage organ disease die waiting for an organ that never comes. With our third xenograft production facility now open and clinical trials underway, United Therapeutics is moving closer to its goal of providing transplantable organs to the people who need them. It is fitting that this facility is named for Dr. Griffith and Dr. Montgomery, whose first-in-human surgeries turned xenotransplantation from a theoretical possibility into a clinical reality,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics.

Bartley P. Griffith, MD, FACS, FRCS revolutionized medicine by pioneering artificial hearts that have now been implanted over 15,000 times. He made history by successfully conducting the world’s first transplants of United Therapeutics’ xenohearts in 2022 and 2023. Dr. Griffith’s creation of a nationwide network of expert organ procurement surgeons has supported United Therapeutics’ Lung Bioengineering program, which uses ex vivo lung perfusion technology to enable transplant surgeons to evaluate marginal donor lungs that frequently go untransplanted, and it has led to hundreds of lung transplants.

Robert A. Montgomery, MD, DPhil, FACS is known for many transformative innovations in transplantation that have enabled thousands of successful transplants. His research efforts led to “kidney exchanges” and passage of the Norwood Act, which allows living kidney donors who are biologically incompatible with their own intended recipients to swap with another incompatible pair. Dr. Montgomery’s work drastically improved treatment for antibody-mediated organ rejection, a significant obstacle to successful xenotransplantation. In 2025, Dr. Montgomery successfully transplanted the first xenokidney into a patient with end-stage renal disease (ESRD) in United Therapeutics’ EXPAND clinical trial, a watershed moment for United Therapeutics’ vision to broaden access to transplantable organs.

About United Therapeutics Xenotransplantation Program

United Therapeutics is advancing clinical trials intended to support a Biologics License Application with the U.S. Food and Drug Administration for each of its three investigational xenotransplantation products, UKidney™, UThymoKidney™, and UHeart™:

  • EXPAND (NCT06878560) is a multicenter, open-label, safety and efficacy study of UKidney in patients with ESRD;

  • EXTEND (NCT07224763) is a multicenter, open-label, safety and efficacy study of UThymoKidney in patients with ESRD; and

  • EXPRESS is an open-label, safety and efficacy study of UHeart in patients with advanced heart failure. It will start at a single center with potential to include other centers if the initial data are supportive.

The UKidney and UHeart are derived from a pig with 10 gene edits. Six human genes are added to the pig genome to facilitate immunological acceptance and compatibility of the organ in the human recipient. Four porcine genes are inactivated or “knocked out” to reduce the risk of organ rejection and to moderate organ growth.

The UThymoKidney is derived from a pig with a single gene edit together with tissue from the pig’s thymus. The pig’s thymus tissue is intended to condition the recipient’s immune system to recognize the UThymoKidney as “self” and reduce the likelihood of rejection.

Alternative organ sources are needed, as demand for organ transplants far exceeds the supply of available organs. If clinical trials are successful, the UKidney, UThymoKidney, and UHeart have the potential to mitigate the world’s organ shortage crisis.

United Therapeutics’ xeno-organs are all investigational-stage products which have not been approved in any jurisdiction for any indication.

About United Therapeutics

Founded by CEO Martine Rothblatt to discover a cure for her daughter’s life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at www.unither.com and follow us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding: our plans to develop and obtain FDA approval for our xeno-organ products; the potential for our UKidney, UThymoKidney, and UHeart products to mitigate the world’s organ shortage crisis; the potential for our DPF facilities to enable us to scale the manufacturing of our xeno-products following regulatory approvals; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of October 20, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

UKIDNEY, UTHYMOKIDNEY, and UHEART are trademarks of United Therapeutics Corporation.

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