Latest news with #UKidney
Yahoo
15-05-2025
- Business
- Yahoo
Stewartville pig-to-human transplant facility to be complete in 2026
May 14—STEWARTVILLE, Minn. — A very different kind of "hog farm" is being built by United Therapeutics Corp. on the edge of Stewartville to raise gene-edited pigs in a $110 million pathogen-free facility to harvest kidneys and hearts for transplantation into humans. Maryland-based United Therapeutics, a $14 billion pharmaceutical and biotech firm, paid $4.5 million to buy 32 acres in the Schumann Business Park in August 2024. Construction of the new 65,000-square-foot complex is moving quickly. United Therapeutics has two types of pigs that have been altered at the genetic-level to make their hearts and kidneys less likely to be rejected when transplanted into a human. UT's Head of Investor & Media Relations Dewey Steadman recently visited the site to "make sure that our neighbors know what we're doing." He explained that the plan is to complete the construction and introduce the first pigs in 2026. Once the first pigs are born inside the facility, the site will be commissioned in 2027 and start producing up to 125 organs — kidneys and hearts — for human transplantation. The Stewartville project is moving forward just as many aspects of UT's pig-to-human transplant efforts are gaining traction. It conducted the first successful pig-to-human heart transplant in 2022 and the first pig-to-human kidney transplant in 2024. In February, the U.S. Food and Drug Administration approved a clinical trial of United Therapeutics' "UKidney," which is derived from a 10 gene-edited source pig. The first transplant in this trial is expected to be performed around mid-2025. The 10 gene-edited animals at the Stewartville facility will produce "UKidneys" and "UHearts" and pigs with one gene-edit will be the source of "UThymoKidneys." This is the first human clinical trial of a xeno-organ, though UT has applied for more trials for other of their organs. Steadman said while the research is progressing, it will take some time for xenotransplantation to be a common practice. "We hope to have this approved by the FDA by the end of the decade," he said. UT believes the need for more organs is only going to grow as the demand for organs outstrips the supply. More than 557,000 patients in the U.S. are on dialysis, according to the American Kidney Fund. United Therapeutics estimates that approximately 500,000 dialysis patients in the U.S. will not qualify for the kidney transplant list or may not be prioritized high enough on the waiting list to receive a transplant. The Stewartville facility will need about 20 employees at a base wage of $75,000 a year. The animals producing United Therapeutics' three types of gene-edited organs will live their entire lives in the sterile environment. Dewey said the facility has the capacity to house up to 200 of the special pigs. The Stewartville complex will be a twin of UT's pathogen-free facility in Christianburg, Virginia, which opened in March 2024. Steadman explained why UT chose to build in Stewartville. "Stewartville checked a number of boxes for us. The town of Stewartville has been extremely cooperative and excited about working with us," he said. "... The proximity of Mayo Clinic, I-90 and the (Rochester International) Airport were all factors." Organs for transplanting have an ideal window of 10 to 12 hours, so access to transportation is crucial. The unique combination of a skilled medical and agricultural workforce also made Stewartville attractive. While swine are at the heart of this project, Steadman added that people in the area should not be concerned that the UT facility will smell like a traditional pig farm. "The air that goes into the pigs will be filtered and the air that comes out will be completely filtered, too. You won't know that pigs are in the facility," he said. "This is a very high-tech pharmaceutical plant first, and then a pig farm second." While Mayo Clinic is not currently involved with the xenotransplantation operation, UT and Mayo Clinic do work together on human lung transplants in Florida. The company's CEO and founder Dr. Martine Rothblatt is also a member of Mayo Clinic's Board of Trustees. Rothblatt is a medical ethicist, an inventor, an attorney and a pilot. Rothblatt, who co-founded Sirius Satellite Radio, created United Therapeutics in 1996 to find a cure for her daughter's medical condition — pulmonary arterial hypertension.
Associated Press
30-04-2025
- Business
- Associated Press
United Therapeutics Corporation Reports First Quarter 2025 Financial Results
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Apr 30, 2025-- United Therapeutics Corporation (Nasdaq: UTHR ), a public benefit corporation, today announced its financial results for the quarter ended March 31, 2025. Total revenues in the first quarter of 2025 grew 17 percent year-over-year to $794.4 million, compared to $677.7 million in the first quarter of 2024. '2025 is off to a tremendous start as we reported yet another quarter of record revenue,' said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. 'Beyond the continued execution of our foundational wave of growth in the commercial business, throughout the balance of the year we'll progress our innovation and revolution waves of growth with the readout of TETON 2 in idiopathic pulmonary fibrosis and the planned commencement of our UKidney first in human clinical study, respectively. Moreover, we're excited to advance our multiple shots on goal approach to creating an unlimited supply of transplantable organ alternatives with anticipated filings of investigational new drug applications with the FDA for our UHeart and UThymoKidney products.' Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, 'This quarter's record revenue performance reflects the diligent efforts and strategic focus of our commercial team as we continue to expand our reach and solidify our position in the pulmonary hypertension marketplace as the prostacyclin products of choice. We look forward to building on this performance for the remainder of the year.' First Quarter 2025 Financial Results Key financial highlights include (dollars in millions, except per share data): Revenues The table below presents the components of total revenues (dollars in millions): Total Tyvaso revenues grew by 25 percent to $466.3 million in the first quarter of 2025, compared to $372.5 million in the first quarter of 2024. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $97.4 million and, to a lesser extent, a price increase, partially offset by higher gross-to-net deductions. The increase in Tyvaso DPI quantities sold was primarily due to continued growth in the number of patients following the product's launch, including growth in utilization by patients with pulmonary hypertension associated with interstitial lung disease and, to a lesser extent, increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act ( IRA ). The growth in nebulized Tyvaso revenues resulted primarily from an increase in international nebulized Tyvaso revenues, driven by the timing of orders by our international distributors and does not precisely reflect trends in underlying patient demand. The growth in Remodulin revenues resulted primarily from an increase in U.S. Remodulin revenues, driven by an increase in quantities sold. The growth in Orenitram revenues resulted primarily from an increase in quantities sold and, to a lesser extent, a price increase, partially offset by higher gross-to-net deductions. The increase in quantities sold was driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. The table below presents the breakdown of total revenues between the United States and rest-of-world ( ROW ) (dollars in millions): Expenses Cost of sales. The table below summarizes cost of sales by major category (dollars in millions): Cost of sales, excluding share-based compensation. Cost of sales for the three months ended March 31, 2025 increased as compared to the same period in 2024, primarily due to an increase in royalty expense and product costs, particularly for Tyvaso DPI driven by growth in Tyvaso DPI revenues. Research and development. The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Research and development, excluding share-based compensation. Research and development expense for the three months ended March 31, 2025 increased as compared to the same period in 2024, primarily due to: (1) an increase of $30.0 million related to milestone payments for drug delivery device technologies; (2) an increase of $6.6 million related to adjustments to the fair value of our contingent consideration obligations for manufactured organ and organ alternative projects; and (3) increased expenditures related to manufactured organ and organ alternative projects. Selling, general, and administrative. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): General and administrative, excluding share-based compensation. General and administrative expense for the three months ended March 31, 2025 increased as compared to the same period in 2024, primarily due to an increase in personnel expense due to growth in headcount. Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions): Other (expense) income, net. The change in other (expense) income, net for the three months ended March 31, 2025, as compared to the same period in 2024, was primarily due to net unrealized losses on equity securities. Income tax tax expense for the three months ended March 31, 2025 and 2024 was $101.3 million and $92.0 million, respectively. Our effective income tax rate ( ETR ) for the three months ended March 31, 2025 and 2024 was 24 percent and 23 percent, respectively. Our ETR for the three months ended March 31, 2025 increased compared to our ETR for the three months ended March 31, 2024, primarily due to decreased excess tax benefits from share-based compensation. Webcast We will host a webcast to discuss our first quarter 2025 financial results on Wednesday, April 30, 2025, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at A replay of the webcast will also be available at the same location on our website. United Therapeutics: Enabling Inspiration At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun; we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation ( PBC ). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. You can learn more about what it means to be a PBC here: 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 related to our waves of growth, the anticipated readout of the TETON 2 clinical trial in idiopathic pulmonary fibrosis; the planned commencement of our UKidney first in human clinical study; our plan to create an unlimited supply of transplantable organ alternatives; our anticipated filings of investigational new drug applications with the FDA for our UHeart and UThymoKidney products; our plan to continue to expand our reach and solidify our position in the pulmonary hypertension marketplace as the prostacyclin products of choice; our plan to build on our commercial performance for the remainder of the year; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. 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 April 30, 2025, 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. ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries. UHEART, UKIDNEY, and UTHYMOKIDNEY are trademarks of United Therapeutics Corporation and/or its subsidiaries. ADCIRCA is a registered trademark of Eli Lilly and Company. Category: Earnings View source version on CONTACT: Dewey Steadman at (202) 919-4097 (media/investors) Harry Silvers at (301) 578-1401 (investors) KEYWORD: UNITED STATES NORTH AMERICA NORTH CAROLINA MARYLAND INDUSTRY KEYWORD: BIOTECHNOLOGY OTHER HEALTH HEALTH PHARMACEUTICAL CARDIOLOGY SOURCE: United Therapeutics Corporation Copyright Business Wire 2025. PUB: 04/30/2025 06:30 AM/DISC: 04/30/2025 06:29 AM
Yahoo
11-04-2025
- Health
- Yahoo
Transplanted pig kidney removed after functioning in living patient for more than four months
A genetically engineered pig kidney helped Towana Looney enjoy 130 days without the need for dialysis before the organ was removed last week. It's the longest a human has ever lived with a pig organ, marking another step forward in the burgeoning field of xenotransplantation, or the practice of transplanting animal organs into humans. Looney, a 53-year-old-woman from Alabama, had been on dialysis for nine years before she received the pig kidney transplant in late November, becoming only the third person to receive a kidney from a gene-edited pig while alive. She left the hospital 11 days after surgery at NYU Langone Transplant Institute, staying at an apartment near the hospital so she could get checkups every day. But medical complications developed after months of stability, leading to the difficult decision to remove the organ on April 4. 'In early April, she had a reduction in renal function due to acute rejection. What triggered the rejection episode after a long period of stability is being actively investigated, but it followed a lowering of her immunosuppression regimen to treat an infection unrelated to the pig kidney,' Dr. Robert Montgomery, director of the NYU Langone Transplant Institute and chair of NYU Langone Health's surgery department, said in a statement. 'The decision was made by Ms. Looney and her doctors that the safest intervention would be to remove the kidney and return to dialysis rather than giving additional immunosuppression. This preserves future possibilities for transplantation for her as knowledge and innovations progress,' he said. United Therapeutics Corporation, the biotech company that developed the modified pig kidney – known as a UKidney – celebrated the bravery and enthusiasm Looney has shown throughout the xenotransplantation journey. 'One of the biggest challenges for transplant recipients – human-to-human or pig-to-human – is the prevention and management of infections while simultaneously balancing the level of immunosuppression medications required to prevent rejection, especially in the first months after surgery,' the company said in a statement. 'We will learn more about the circumstances that led to removal of the UKidney, but current evidence suggests that the UKidney functioned well up until the time of rejection, which appears to have occurred due to a reduction in immunosuppression while treating infection unrelated to the xenokidney,' they said. 'We expect physicians at NYU will share their findings in a peer-reviewed publication in the future.' Looney donated a kidney to help save her mother's life in 1999 but later developed kidney failure after her remaining kidney was damaged by preeclampsia, a serious pregnancy complication involving persistent high blood pressure. After years on the waitlist for an organ transplant, she began to develop problems associated with chronic dependence on dialysis. Without a donor match, she would die – but the complications she had developed made it more difficult to find one. When she heard about the option to try a pig kidney transplantation, she jumped at the chance to try it. 'Without a pathway to receiving a human kidney, she decided a gene-edited pig kidney was worth a try, and a lot of people rallied around her decision, including her husband and family,' Montgomery said at the time. Looney is now back home in Alabama and says she's grateful for the opportunity she had to participate in the research. 'For the first time since 2016, I enjoyed time with friends and family without planning around dialysis treatments,' she said in a statement. 'Though the outcome is not what anyone wanted, I know a lot was learned from my 130 days with a pig kidney – and that this can help and inspire many others in their journey to overcome kidney disease. I remain thankful to all of the doctors and researchers at NYU Langone for all they are doing.' More than 90,000 people in the United States are on the waitlist to receive a kidney transplant, according to data from the Organ Procurement and Transplantation Network, accounting for the vast majority of people waiting to receive an organ donation. The average wait time for a kidney is three to five years at most centers, and about 13 people die each day waiting. Dialysis – a procedure to help remove waste and extra fluid from the blood – can be helpful in the short term but can do only 10% to 15% of what a healthy kidney does, and people on dialysis have a 50% chance of dying in the five years after they start the treatment, studies show. The US Food and Drug Administration allows doctors to transplant organs from pigs into humans under what's commonly known as 'compassionate use,' which permits use of an experimental therapy or procedure if 'comparable or satisfactory' options aren't available. Pigs' organs are similar to humans', and the speed of pigs' reproduction means their organs can be procured quickly. Scientists can edit the genes of the pig to reduce the risk that a human body will reject its organ. Of the three people to receive a kidney from a gene-edited pig while alive, Looney was the first to receive a kidney with 10 gene edits, and United Therapeutics announced in February that it was cleared by the FDA to use this type of pig kidney in the first human clinical trials to study xenotransplantation. The company says they are in regular contact with the FDA about this and expect to perform the first of six initial transplants in people with end-stage kidney disease in the middle of 2025, with the intent of expanding the trial to a total of 50 patients. Some experts foresee pig kidney transplant becoming an established option for patients within a decade, a major advancement that would be possible because of people like Looney. 'Towana's willingness to endeavor into the unknown to help solve the nation's organ shortage crisis will impact many more lives after her. We celebrate her tremendous courage and sacrifice,' Montgomery said. 'She lived with a pig kidney longer than any other human in history, and the field has learned a great deal from her. Her contribution has furthered the hope and promise of genetically engineered pig organs as an alternative source to human organs.' United Therapeutics echoed the same sentiment. 'Mrs. Looney's bravery has enabled major advancements in the field of xenotransplantation and adds to the foundational insights made possible by the contributions of other patients. Her case will continue to add to the scientific community's understanding of xenotransplantation, from the initial transplant procedure to the post-transplant management of the xenograft,' the company said. 'We keep Mrs. Looney and her family in our thoughts, and we wish her a speedy recovery.' CNN's Amanda Sealy contributed to this report.
CNN
11-04-2025
- Health
- CNN
Transplanted pig kidney removed after functioning in living patient for more than four months
A genetically engineered pig kidney helped Towana Looney enjoy 130 days without the need for dialysis before the organ was removed last week. It's the longest a human has ever lived with a pig organ, marking another step forward in the burgeoning field of xenotransplantation, or the practice of transplanting animal organs into humans. Looney, a 53-year-old-woman from Alabama, had been on dialysis for nine years before she received the pig kidney transplant in late November, becoming only the third person to receive a kidney from a gene-edited pig while alive. She left the hospital 11 days after surgery at NYU Langone Transplant Institute, staying at an apartment near the hospital so she could get checkups every day. But medical complications developed after months of stability, leading to the difficult decision to remove the organ on April 4. 'In early April, she had a reduction in renal function due to acute rejection. What triggered the rejection episode after a long period of stability is being actively investigated, but it followed a lowering of her immunosuppression regimen to treat an infection unrelated to the pig kidney,' Dr. Robert Montgomery, director of the NYU Langone Transplant Institute and chair of NYU Langone Health's surgery department, said in a statement. 'The decision was made by Ms. Looney and her doctors that the safest intervention would be to remove the kidney and return to dialysis rather than giving additional immunosuppression. This preserves future possibilities for transplantation for her as knowledge and innovations progress,' he said. United Therapeutics Corporation, the biotech company that developed the modified pig kidney – known as a UKidney – celebrated the bravery and enthusiasm Looney has shown throughout the xenotransplantation journey. 'One of the biggest challenges for transplant recipients – human-to-human or pig-to-human – is the prevention and management of infections while simultaneously balancing the level of immunosuppression medications required to prevent rejection, especially in the first months after surgery,' the company said in a statement. 'We will learn more about the circumstances that led to removal of the UKidney, but current evidence suggests that the UKidney functioned well up until the time of rejection, which appears to have occurred due to a reduction in immunosuppression while treating infection unrelated to the xenokidney,' they said. 'We expect physicians at NYU will share their findings in a peer-reviewed publication in the future.' Looney donated a kidney to help save her mother's life in 1999 but later developed kidney failure after her remaining kidney was damaged by preeclampsia, a serious pregnancy complication involving persistent high blood pressure. After years on the waitlist for an organ transplant, she began to develop problems associated with chronic dependence on dialysis. Without a donor match, she would die – but the complications she had developed made it more difficult to find one. When she heard about the option to try a pig kidney transplantation, she jumped at the chance to try it. 'Without a pathway to receiving a human kidney, she decided a gene-edited pig kidney was worth a try, and a lot of people rallied around her decision, including her husband and family,' Montgomery said at the time. Looney is now back home in Alabama and says she's grateful for the opportunity she had to participate in the research. 'For the first time since 2016, I enjoyed time with friends and family without planning around dialysis treatments,' she said in a statement. 'Though the outcome is not what anyone wanted, I know a lot was learned from my 130 days with a pig kidney – and that this can help and inspire many others in their journey to overcome kidney disease. I remain thankful to all of the doctors and researchers at NYU Langone for all they are doing.' More than 90,000 people in the United States are on the waitlist to receive a kidney transplant, according to data from the Organ Procurement and Transplantation Network, accounting for the vast majority of people waiting to receive an organ donation. The average wait time for a kidney is three to five years at most centers, and about 13 people die each day waiting. Dialysis – a procedure to help remove waste and extra fluid from the blood – can be helpful in the short term but can do only 10% to 15% of what a healthy kidney does, and people on dialysis have a 50% chance of dying in the five years after they start the treatment, studies show. The US Food and Drug Administration allows doctors to transplant organs from pigs into humans under what's commonly known as 'compassionate use,' which permits use of an experimental therapy or procedure if 'comparable or satisfactory' options aren't available. Pigs' organs are similar to humans', and the speed of pigs' reproduction means their organs can be procured quickly. Scientists can edit the genes of the pig to reduce the risk that a human body will reject its organ. Of the three people to receive a kidney from a gene-edited pig while alive, Looney was the first to receive a kidney with 10 gene edits, and United Therapeutics announced in February that it was cleared by the FDA to use this type of pig kidney in the first human clinical trials to study xenotransplantation. The company says they are in regular contact with the FDA about this and expect to perform the first of six initial transplants in people with end-stage kidney disease in the middle of 2025, with the intent of expanding the trial to a total of 50 patients. Some experts foresee pig kidney transplant becoming an established option for patients within a decade, a major advancement that would be possible because of people like Looney. 'Towana's willingness to endeavor into the unknown to help solve the nation's organ shortage crisis will impact many more lives after her. We celebrate her tremendous courage and sacrifice,' Montgomery said. 'She lived with a pig kidney longer than any other human in history, and the field has learned a great deal from her. Her contribution has furthered the hope and promise of genetically engineered pig organs as an alternative source to human organs.' United Therapeutics echoed the same sentiment. 'Mrs. Looney's bravery has enabled major advancements in the field of xenotransplantation and adds to the foundational insights made possible by the contributions of other patients. Her case will continue to add to the scientific community's understanding of xenotransplantation, from the initial transplant procedure to the post-transplant management of the xenograft,' the company said. 'We keep Mrs. Looney and her family in our thoughts, and we wish her a speedy recovery.' CNN's Amanda Sealy contributed to this report.
