Graft Rejection

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, announced the results of its DEFINE-HT clinical trial in heart transplantation, which were shared today, April 29, 2025, in an oral presentation at the International Society for Heart and Lung Transplantation 45th Annual Meeting in Boston, MA. DEFINE-HT is the first prospective, multicenter study in heart transplant recipients designed to assess whether elevated levels of donor-derived cell-free DNA (dd-cfDNA), as measured by Prospera Heart with DQS, are associated with adverse clinical outcomes. Following heart transplant, Prospera testing was performed concurrently with rejection surveillance monitoring, including endomyocardial biopsies (EMB), for up to one year. Findings from the study, which included more than 1,100 dd-cfDNA samples, demonstrated that dd-cfDNA significantly correlated with adverse outcomes, a composite endpoint defined as the total number of treated rejections, graft dysfunctions, re-transplantations, and deaths at one year after heart transplant. Key findings include: Patients with at least one elevated dd-cfDNA measurement were significantly more at risk for experiencing an adverse event (HR: 2.56, p=0.0299). Elevated dd-cfDNA predicted graft dysfunction 3x more than biopsy. Prospera with DQS demonstrated a stronger correlation with clinical outcomes compared to donor fraction alone. “The results of DEFINE-HT show that dd-cfDNA can predict clinical outcomes after heart transplantation, which can allow for improved and personalized patient management based on individual risk,” said Palak Shah, M.D., M.S., national principal investigator for DEFINE-HT, director of the Inova Cardiovascular Genomics Center, and medical director of mechanical circulatory support at Inova Fairfax Medical Campus. “Through vigorous research, we continue to drive innovative advancements in heart transplantation, finding less invasive approaches that lead to better patient outcomes.” “In combination with a better understanding of the association of dd-cfDNA and clinical outcomes, DEFINE-HT underscores the utility of Prospera as a tool to help identify patients who may be at risk for adverse outcomes,” said Michael Olympios, M.D., medical director, heart transplant at Natera. “Importantly, the insights gained from this study suggest that Prospera has the potential to obviate invasive surveillance EMB, which will be investigated in an ongoing multi-center, randomized, comparative effectiveness study comparing dd-cfDNA and EMB surveillance (ACES-EMB).” About Prospera The Prospera™ test leverages Natera’s core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient’s blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 250 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com. Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

CARY, N.C., Feb. 25, 2025 /PRNewswire/ -- Veloxis Pharmaceuticals, Inc. (Veloxis), a global specialty pharmaceutical company and an Asahi Kasei company, has announced that the United States Adopted Name (USAN) Council has approved the nonproprietary (generic) name "pegrizeprument" for its lead transplant candidate, VEL-101, a novel investigational maintenance immunosuppressive agent. The USAN Council, which includes experts from the American Medical Association, the U.S. Pharmacopeial Convention and the Food and Drug Administration, provides clear, standardized drug names that facilitate communication among healthcare professionals, patients, and researchers worldwide. Adopting pegrizeprument ensures consistent and reliable drug identification, helping reduce medication errors, enhance patient safety, and streamline drug identification for healthcare providers. This new generic name also highlights the importance of international drug recognition – ensuring clarity across markets regardless of the brand name under which the drug is intended to be marketed. "The adoption of the name pegrizeprument marks another key milestone for our innovative investigational immunosuppressive therapy as we prepare to move to the next phase of development," says Tunde Otulana, M.D., Chief Medical Officer at Veloxis. "It reinforces our dedication to developing innovative therapies to improve the lives of transplant recipients worldwide." About pegrizeprument (formerly VEL-101) Pegrizeprument is a pegylated monoclonal monovalent antibody fragment that binds to and blocks CD28-mediated effector-T cell costimulation, without blocking CTLA-4, an important protein found on T cells that naturally helps keep the body's immune responses in check. Pegrizeprument is, therefore, expected to have a dual-mechanism of action where in a direct manner, it blocks CD28-mediated T cell activation, and indirectly, it allows for CTLA-4 mediated immunosuppressive functions. Also known as FR104, pegrizeprument was licensed by Veloxis from OSE Immunotherapeutics in April 2021. As part of the license agreement, Veloxis obtained worldwide rights to develop, manufacture, and commercialize pegrizeprument for all transplant indications. Pegrizeprument is being developed for the prevention of acute rejection in recipients of kidney transplants and potentially in recipients of other solid organs. About Veloxis Pharmaceuticals, Inc. Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, is a global specialty pharmaceutical company committed to improving the lives of transplant patients. Headquartered in Cary, North Carolina, USA, Veloxis is focused on the global development and commercialization of medications utilized by transplant patients and by patients with serious related diseases. For further information, please visit Veloxis.com. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its Health Care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For further information, please visit Asahi-Kasei.com. SOURCE Veloxis Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

LINCOLNSHIRE, Ill.--( BUSINESS WIRE )--Nexus Pharmaceuticals, LLC announces the U.S Food and Drug Administration (FDA) approval of Tacrolimus Injection 5 mg/mL. Nexus’ Tacrolimus Injection is the first and only vial that will be available. “We are pleased to share the FDA approval of Tacrolimus Injection. Tacrolimus is a critical treatment option for patients requiring immunosuppressive therapy, enhancing their quality of life, and reducing the risk of organ rejection,” says Usman Ahmed, Chief Executive Officer at Nexus Pharmaceuticals, LLC. “We are proud to provide another reliable and effective treatment that supports successful patient outcomes and overall healthcare efficiency.” Tacrolimus Injection 5 mg/mL (Single-Dose Vial) in a 10-pack will be launching soon. About Nexus Pharmaceuticals, LLC : Nexus Pharmaceuticals, LLC, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality drug products fulfill a critical unmet medical need and deliver dependable life-saving treatment options when and where they’re needed most.