SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. - United Therapeutics (NASDAQ:UTHR) Corporation (NASDAQ: UTHR) has announced the successful transplantation of a gene-edited pig kidney, called UKidney, into a human patient. The procedure took place on November 25, 2024, and marks the company's first such transplant into a living person, following a series of xenotransplants including UHeart and UThymoKidney.
The recipient, Towana Looney, a 53-year-old patient from Alabama, had previously suffered kidney failure. She faced significant challenges in finding a suitable human donor due to high antibody levels, which increase the risk of organ rejection. The UKidney, developed by United Therapeutics’ subsidiary Revivicor, Inc., is designed to be more compatible with the human immune system, featuring 10 genetic modifications to the pig genome.
This groundbreaking procedure was performed under the FDA's expanded access pathway at NYU Langone Health by a surgical team led by Dr. Robert Montgomery. The patient was initially evaluated at the University of Alabama at Birmingham by Dr. Jayme Locke, who also participated in the surgery.
The successful transplant adds to the evidence supporting xenotransplantation as a viable solution to organ shortages. The USRDS Annual Data Report indicates over 550,000 patients with end-stage renal disease relied on dialysis in 2021, with a one-year mortality rate of 15-20% for those on dialysis and a five-year survival rate below 50%.
United Therapeutics, which began xenotransplantation research in 2011, operates a clinical-scale designated pathogen-free facility in Christiansburg, Virginia, and is constructing another in Stewartville, Minnesota, to support future clinical studies. The company, which has achieved a remarkable 25% revenue growth over the last twelve months and maintains strong financial health with an EXCELLENT rating from InvestingPro, is preparing an investigational new drug application (IND) for the UKidney, with plans to initiate a human clinical study in 2025, pending FDA clearance.For investors seeking deeper insights, InvestingPro offers comprehensive analysis with 14 additional ProTips and a detailed Pro Research Report, helping you make informed investment decisions in the biotechnology sector.
The company's efforts in xenotransplantation, regenerative medicine, 3D organ bioprinting, and bio-artificial organs are part of its mission to address the shortage of transplantable organs for patients with end-stage organ disease. United Therapeutics, whose stock has delivered a 69.5% return year-to-date, is working towards initiating clinical trials for its UThymoKidney and UHeart products, following the required preclinical studies.
This report is based on a press release statement from United Therapeutics Corporation.
In other recent news, United Therapeutics reported robust third-quarter financial results, with revenues reaching $748.9 million, a significant increase from the same period in the previous year. These figures were primarily driven by the strong performance of treprostinil-based products such as Tyvaso, which surpassed both Ladenburg Thalmann's and consensus estimates, reaching total sales of $433.8 million. However, not all products met projections, with Remodulin sales falling short of Ladenburg's and consensus estimates, reaching $128.3 million.
United Therapeutics also successfully completed a $1 billion accelerated share repurchase program. Analysts at H.C. Wainwright reaffirmed a Buy rating on the company, citing strategic positioning and proactive measures such as initiating contracts with Part D payers. The firm also increased the price target for United Therapeutics to $425 from the previous $400, reflecting a positive outlook on Tyvaso's performance and an adjusted estimated peak penetration rate for pulmonary arterial hypertension.
Ladenburg Thalmann, on the other hand, maintained a Neutral rating on United Therapeutics but raised the price target to $344 from the previous $319. The company is also eyeing future clinical milestones, including the TETON 2 study results, and is awaiting a potential FDA decision on its Centralized Lung Evaluation System in 2025. These recent developments underscore United Therapeutics' strategic focus on expanding commercial ventures and research and development, setting the stage for continued growth in the biotechnology sector.
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