Rozanolixizumab

UCB will showcase 18 abstracts, including an oral presentation, demonstrating continued commitment to advancing targeted treatments for generalized myasthenia gravis (gMG). Presentations include new post hoc analyses considering corticosteroid dose tapering during treatment with RYSTIGGO® (rozanolixizumab-noli)1 and the impact of ZILBRYSQ® (zilucoplan) on Myasthenia Gravis Quality of Life 15-revised (MG-QoL15r) items.2 ATLANTA, Oct. 29, 2025 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that it will be presenting new data highlighting insights on patient outcomes with rozanolixizumab and zilucoplan for the treatment of generalized myasthenia gravis (gMG) at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session, taking place between October 29 and November 1, 2025, in San Francisco. A total of 18 abstracts will be presented at AANEM and the MGFA scientific session, highlighting UCB's dedication to driving advancements in gMG treatment. These presentations will cover data on rozanolixizumab and zilucoplan, including new insights on corticosteroid-sparing strategies and quality of life, and long-term safety and effectiveness data. Additionally, insights from a real-world study on user characteristics and adherence patterns from the HumaMG app will be shared, reinforcing UCB's commitment to improving gMG management. "Empowering patients with innovative solutions is at the core our purpose at UCB," said Donatello Crocetta, Global Head of Medical Affairs & Chief Medical Officer at UCB. "Our presentations at the AANEM Annual Meeting and MGFA Scientific Session showcase our focus on developing treatment options that not only highlight clinical management but also quality of life, providing meaningful outcomes that make a difference for those living with gMG." "At UCB, we are deeply proud to present a robust range of data at this year's AANEM Annual Meeting and MGFA Scientific Session, demonstrating our commitment to elevating the lives of patients with gMG through shared decision-making and continuous collaboration with healthcare professionals," added Kimberly, Moran, PhD, SVP & Head, US Rare Diseases. "People living with gMG face unpredictable symptoms that can greatly impact their ability to perform daily activities. Expanding the body of evidence generation of the risks and benefits of our gMG targeted therapies is central to our mission of delivering meaningful, sustainable clinical improvements to address the unique challenges these patients encounter." Key UCB scientific and real-world data to be presented at AANEM and the MGFA Scientific Session include: An oral presentation focusing on data from the double-blind Phase 3 MycarinG study and its open-label extensions (OLE) including an analysis of corticosteroid dose tapering during treatment with rozanolixizumab in patients with gMG.1 A new analysis of treatment response from the Phase 3 MycarinG study and its open-label extensions offering information on efficacy of rozanolixizumab in a clinical setting.3 Data from a further analysis of the Phase 3 MycarinG study explores the long-term safety of cyclic rozanolixizumab treatment in patients with gMG to evaluate its potential for sustained therapeutic use. 4 Post hoc data from the Phase 3 RAISE-XT trial examining zilucoplan's impact in the Myasthenia Gravis Quality of Life 15-item revised (MG-QoL15t) total score.2 New data on the long-term effectiveness of zilucoplan, focusing on severe exacerbations in gMG based on predictive modeling from the Phase 3 RAISE and RAISE-XT clinical trial and a U.S. real-world database.5 From the RAISE-XT 120-week follow-up, new post hoc data looking at the long-term effect of zilucoplan treatment on fatigue.6 An analysis exploring user characteristics and adherence patterns among individuals living with Myasthenia Gravis (MG), leveraging data from the HumaMG app to provide real-world insights into patient management and engagement.7 UCB is also hosting a panel discussion entitled 'Continuing the Conversation - Subpopulations with Barriers to Care in Myasthenia Gravis' on October 29, 2025. There will also be a UCB-sponsored Industry Therapeutic Update on expert perspectives on two targeted generalized myasthenia gravis treatments on October 31, 2025. UCB presentations during AANEM and MGFA Scientific Session 2025 For further information, contact UCB: Global Communications Nick Francis T +44 7769 307745 [email protected] Rare Disease Communications Daphne Teo T +1 (770) 880-7655 [email protected] Corporate Communications, Media Relations Laurent Schots T +32.2.559.92.64 [email protected] Investor Relations Antje Witte T +32.2.559.94.14 [email protected] About generalized myasthenia gravis (gMG) gMG is a rare autoimmune disease with a global prevalence of 100–350 cases per 1 million people.8 People living with gMG can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty with swallowing, chewing and talking, as well as life-threatening weakness of the muscles of respiration.9,10 In gMG, pathogenic autoantibodies can impair synaptic transmission at the neuromuscular junction (NMJ) by targeting specific proteins on the post-synaptic membrane.11 This disrupts the ability of the nerves to stimulate the skeletal muscle and results in a weaker contraction.9,10 gMG can occur in any race, gender or age.9,10 About rozanolixizumab Rozanolixizumab 140 mg/ml solution for injection is a subcutaneously administered, humanized monoclonal antibody that specifically binds, with high affinity, to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and Immunoglobulin G (IgG), accelerating the catabolism of antibodies and reducing the concentration of pathogenic IgG autoantibodies.12 In June 2023, rozanolixizumab-noli was approved by the FDA, for the treatment of gMG in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive, having been granted Priority Review for its Biologic License Application (BLA).13 About zilucoplan Zilucoplan is a once-daily SC injection, self-administered peptide inhibitor of complement component 5 (C5 inhibitor).14 As the only self-administered C5 inhibitor targeted therapy for gMG, zilucoplan may inhibit complement-mediated damage to the neuromuscular junction through its targeted mechanism of action.14 In October 2023, zilucoplan was approved by the U.S. Food and Drug Administration (FDA) for the treatment of gMG in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.14 Orphan designation was granted by the FDA in 2019 to zilucoplan for the treatment of myasthenia gravis.15 About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of € 6.15 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter:@UCB_news. Forward-looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. 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Important Safety Information about RYSTIGGO® (rozanolixizumab-noli) in the US 13 RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.13 IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Infections: RYSTIGGO may increase the risk of infection. Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. Immunization Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO. Aseptic Meningitis: Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care. Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO. Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after for clinical signs and symptoms of hypersensitivity reactions. If a reaction occurs, institute appropriate measures if needed. ADVERSE REACTIONS In a placebo-controlled study, the most common adverse reactions (reported in at least 10% of RYSTIGGO-treated patients) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. Serious infections were reported in 4% of patients treated with RYSTIGGO. Three fatal cases of pneumonia were identified, caused by COVID-19 infection in two patients and an unknown pathogen in one patient. Six cases of infections led to discontinuation of RYSTIGGO. Please refer to the full Prescribing Information for additional Important Safety Information. Important Safety Information about ZILBRYSQ® (zilucoplan) in the US 14 ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.14 IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING WARNING: SERIOUS MENINGOCOCCAL INFECTIONS ZILBRYSQ, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ZILBRYSQ, unless the risks of delaying therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccination against meningococcal bacteria in patients receiving a complement inhibitor. Patients receiving ZILBRYSQ are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ZILBRYSQ REMS. CONTRAINDICATIONS ZILBRYSQ is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection. WARNINGS AND PRECAUTIONS Serious Meningococcal Infections ZILBRYSQ, a complement inhibitor, increases a patient's susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initiation of ZILBRYSQ treatment is contraindicated in patients with unresolved serious Neisseria meningitidis infection. Complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks prior to administration of the first dose of ZILBRYSQ, according to current ACIP recommendations for patients receiving a complement inhibitor. If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Consider interruption of ZILBRYSQ in patients who are undergoing treatment for serious meningococcal infection, depending on the risks of interrupting treatment in the disease being treated. ZILBRYSQ REMS Due to the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a REMS called ZILBRYSQ REMS. Under the ZILBRYSQ REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risk of serious meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines. Additional information on the REMS requirements is available at or 1-877-414-8353. Other Infections Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported in patients treated with complement inhibitors. ZILBRYSQ blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Administer vaccinations for the prevention of Streptococcus pneumoniae infection according to ACIP recommendations. Patients receiving ZILBRYSQ are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination. Pancreatitis and Other Pancreatic Conditions Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ. Patients should be informed of this risk before starting ZILBRYSQ. Obtain lipase and amylase levels at baseline before starting treatment with ZILBRYSQ. Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved. ADVERSE REACTIONS In a placebo-controlled study, the most common adverse reactions (reported in at least 10% of gMG patients treated with ZILBRYSQ) were injection site reactions, upper respiratory tract infections, and diarrhea. Please refer to the full Prescribing Information for additional Important Safety Information. References: 1. Pascuzzi R, et al. 2025. Corticosteroid dose tapering during treatment with rozanolixizumab in patients with gMG: post hoc analysis. Oral presentation (Wednesday Session C) 110 at: MGFA Scientific Session at The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM). 2025 October 29-31; California, USA. 2. Weiss, MD, et al. Interpreting patient quality-of-life experience with zilucoplan treatment in gMG in RAISE and RAISE-XT. Poster presented at: MGFA Scientific Session at The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM). 2025 October 29-31; California, USA. 3. Vu T, et al. Response to rozanolixizumab in patients with gMG: Final pooled analysis of MycarinG and open-label extension studies. Poster presented at: MGFA Scientific Session at The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2025 October 29-31; California, USA. 4. Habib AA, et al. Long-term safety of cyclic rozanolixizumab treatment in patients with gMG: a final analysis of phase 3 studies. Poster presented at: MGFA Scientific Session at The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2025 October 29-31; California, USA. 5. Freimer M, et al. The long-term effectiveness of zilucoplan in MG: predictive modeling in a US real-world database. Poster presented at: MGFA Scientific Session at The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2025 October 29-31; California, USA. 6. Weiss, MD, et al. Effect of zilucoplan on fatigue in patients with gMG: RAISE-XT 120-week follow-up. Poster presented at: MGFA Scientific Session at The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2025 October 29-31; California, USA. 7. Aral M, et al. Real-world insights from people living with MG: Analysis of user characteristics and adherence patterns from the HumaMG app. Poster presented at: MGFA Scientific Session at The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2025 October 29-31; California, USA. 8. Punga AR, et al. Epidemiology, diagnostics, and biomarkers of autoimmune neuromuscular junction disorders. Lancet Neurol. 2022;21(2):176-88. 9. Myasthenia Gravis. National Institute of Neurological Disorders and Stroke. 2022. . Accessed October 2025. 10. Myasthenia Gravis Foundation of America. Overview of MG. . Accessed October 2025. 11. Juel VC, Massey JM. Myasthenia Gravis. Orphanet J Rare Dis. 2007;2:44. 12. Bril V. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis: a randomised, double-blind, placebo-controlled, adaptive Phase 3 study MycarinG study. Lancet Neurol. 2023;22(5):383-94. 13. RYSTIGGO® U.S. PI. . Accessed October 2025. 14. ZILBRYSQ® U.S PI. . Accessed October 2025. 15. Search Orphan Drug Designations and Approvals. US Food and Drug Administration. 2019. . Accessed October 2025. RYSTIGGO® and ZILBRYSQ® are registered trademarks of the UCB Group of Companies. ©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-RZ-2500661 SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Promising study results prompt larger, federally funded, multicenter trial NEW YORK, Oct. 22, 2025 /PRNewswire/ -- Congenital heart block, sometimes referred to as cardiac neonatal lupus, is a rare but potentially life-threatening condition that affects babies born to mothers with specific autoantibodies — called anti-SSA/Ro antibodies — which can attack the fetal heart via its electrical conduction system, leading to a slower heart rate. Most surviving infants with congenital heart block eventually require a pacemaker for life. In a study of one pregnant mother with systemic lupus erythematosus and high levels of anti-SSA/Ro antibodies, NYU Langone Health researchers found a drug that blocks the movement of harmful immune proteins (autoantibodies) across the placenta and into the fetal circulation, preventing development of congenital heart block in the newborn. The researchers who treated the pregnant mother say this is the first case of using the drug, rozanolixizumab, a neonatal Fc receptor (FcRn) inhibitor, to prevent congenital heart block. Publishing in the journal Annals of the Rheumatic Diseases online Oct. 18, the researchers report how they used weekly injections of rozanolixizumab, given from week 14 to 28 of the mother's pregnancy — when the fetal heart is most vulnerable. Ultrasound and at-home heart rhythm checks were used to closely monitor the fetal heartbeat. Rozanolixizumab is a monoclonal antibody drug that prevents a mother's antibodies from crossing the placental barrier by blocking FcRn receptors on the placenta. In addition to blocking placental transfer, this drug reduces autoantibody levels in the mother. During treatment, the researchers report, the autoantibody levels of the mother in the study dropped by more than half. Use of rozanolixizumab was granted under federal compassionate drug use protocols. The mother had already experienced two pregnancies complicated by congenital heart block. One baby died before birth and the other required a pacemaker shortly after birth. Researchers say study results were encouraging. The baby, a girl, was delivered at 37 weeks and weighed 6 pounds, 6 ounces (2.89 kilograms). The baby had no heart complications. The mother had no serious side effects. "This single-patient study suggests the feasibility and safety of using rozanolixizumab to prevent congenital heart block in the offspring of pregnant women who are at high risk of passing along the potentially devasting autoantibodies that associate with fetal disease," said study lead investigator Philip Carlucci, MD. Carlucci is a rheumatology fellow and Colton Center for Autoimmunity – Briedenbach Scholar in the Department of Medicine at the NYU Grossman School of Medicine. "Our research offers proof-of-concept data in support of the hypothesis that no autoantibodies equals no congenital heart block," said study senior investigator Jill Buyon, MD, the Sir Deryck and Lady Va Maughan Professor of Rheumatology at the NYU Grossman School of Medicine." Buyon is also the director of the Lupus Center at NYU Langone. Buyon says the study's promising results have already prompted the National Institutes of Health's Office of Autoimmune Disease Research to partner with the National Institute of Arthritis and Musculoskeletal and Skin Diseases to fund a multicenter trial. The investigation will be led by Buyon and study co-investigators Bettina Cuneo, at the University of Arizona in Tucson, and Justin Brandt, MD, director of maternal fetal medicine at NYU Langone and an associate professor in the Department of Obstetrics and Gynecology at the NYU Grossman School of Medicine. Called AVERT (Atrioventricular Block Elimination with Rozanolixizumab Therapy), the new investigation will enroll pregnant women who have already had a child with congenital heart block and assess whether rozanolixizumab prevents deveopment of the disease. Rozanolixizumab is currently approved by the Food and Drug Administration for treatment of myasthenia gravis, a disease that leads to muscle weakness. Funding support for this study was provided by a gift from Lauren and Andy Levison, and National Institutes of Health grants R01HD100929, R01AR087521, N01AR42220, and U01AI176244. Doses of drug rozanolixizumab were provided by its manufacturer, UCB (Union Chimique Belge). Besides Carlucci, Buyon, and Brandt, Mala Masson, Peter Izmirly, Nicola Fraser, and Nalani Sachan are NYU Langone study co-investigators. Also involved in the study are co-investigators Robert Clancy at Columbia University in New York City, Angus Worthing at Arthritis and Rheumatism Associates in Washington, D.C., and Mary Donofrio at Children's National Hospital, also in Washington. About NYU Langone Health NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. Vizient Inc. has ranked NYU Langone No. 1 out of 118 comprehensive academic medical centers across the nation for four years in a row, and U.S. News & World Report recently ranked four of its clinical specialties No. 1 in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across seven inpatient locations, its Perlmutter Cancer Center, and more than 320 outpatient locations in the New York area and Florida. With $15.5 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise. Media Contact David March 212-404-3528 [email protected] STUDY LINK SOURCE NYU Langone Health System WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED