Rozanolixizumab

UCB will present additional studies and data analyses highlighting UCB's ongoing commitment to improving outcomes for people living with gMG Two studies assessed the bioequivalence and effectiveness of zilucoplan auto-injector (ZLP-AI) administration compared with pre-filled syringe (ZLP-PFS)1 UCB is presenting 21 abstracts in total from its innovative neurology portfolio including 14 epilepsy abstracts and six myasthenia gravis (MG) abstracts at AAN 2026 April 13, 2026 -- UCB, a global biopharmaceutical company, today announced data from two clinical studies assessing ZLP-AI in adult patients who are anti-AChR antibody positivegMG as well as in healthy volunteers. The studies evaluated the effectiveness of a ZLP- AI as a potential new alternative administration option, and the bioequivalence of ZLP-AI relative to ZLP-PFS. ZLP-AI is an investigational administration option for the treatment of gMG in adult patients who are anti-AChR antibody positive and the presentation is currently not approved in the U.S. DV0013 was a Phase 3b open-label, multicenter study in adult patients with gMG self-administering zilucoplan via auto-injector once daily.1 DV0012 was a Phase 1, open-label, single-center, two-period crossover study in healthy adult volunteers to establish bioequivalence of zilucoplan delivered via an auto-injector pen compared with a pre-filled syringe.1 "While symptom control is of course essential, successfully treating gMG should go beyond symptom management and consider tailored therapies that align with a patient's needs, lifestyle and quality-of-life goals," said Omar Sinno, MD, US Medical Strategy Lead, US Rare Disease. UCB will also present five additional studies and data analyses, further highlighting UCB's ongoing commitment to improving outcomes for people living with gMG including: Response to Rozanolixizumab Across Treatment Cycles in Patients with Generalized Myasthenia Gravis: A Post Hoc Analysis of Final Pooled Phase 3 Data: An analysis evaluated the response to rozanolixizumab over multiple treatment cycles in adult patients with gMG, based on their Cycle 1 response.2 Sustained Minimal Symptom Expression in Generalized Myasthenia Gravis: A 120-Week Post Hoc Analysis of RAISE-XT: A post hoc analysis assessed the durability of minimal symptom expression (MSE) response during treatment with zilucoplan in patients with gMG.3 Treatment Goals in Myasthenia Gravis: Expert Consensus Recommendations. Using the RAND/UCLA Appropriateness Method: Seventeen myasthenia gravis experts from North America, Europe and Asia reached consensus on 21 recommendations to define and operationalize treatment goals for patients with MG. Recommendations emphasize the importance of patient engagement and education, reassessing and changing treatment to achieve goals and care coordination with other specialists.4 Treatment Characteristics and Healthcare Resource Utilization Among Adult Patients With Generalized Myasthenia Gravis Initiating Rozanolixizumab in the United States: This real-world, retrospective, non-interventional cohort study of adult patients (N=719) receiving rozanolixizumab in the US evaluated treatment patterns and healthcare resource utilization (HCRU).5 Missed Opportunities for Pharmacist Intervention Among Medicare Fee-for-Service Beneficiaries with Myasthenia Gravis: A Real-World Claims Analysis.6 "At UCB, our approach to rare disease goes beyond developing effective medicines; it's about improving overall experience and outcome for patients," said Kimberly Moran, PhD, SVP & Head, US Rare Disease. "By offering innovative solutions designed around patient needs and preferences, we continue in our mission to help people living with rare diseases better manage their condition through targeted therapies." gMG is a rare neuromuscular autoimmune disease that has a global prevalence of 150–350 cases per 1 million people.7 People living with gMG can experience a variety of symptoms, including severe muscle 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. In gMG, pathogenic autoantibodies can impair synaptic transmission at the neuromuscular junction (NMJ) by targeting specific proteins on the post-synaptic membrane. This disrupts the ability of the nerves to stimulate the skeletal muscle and results in a weaker contraction. gMG can occur in any race, gender or age. UCB, Brussels, Belgium (www.ucb.com) 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 more than 9 000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). References: Petrulis et al. DV0012 and DV0013 Study Teams. Bioequivalence and effectiveness of auto–injector–delivered, self–administered zilucoplan compared with pre–filled syringe. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Pascuzzi et al. Response to rozanolixizumab across treatment cycles in patients with generalized myasthenia gravis: A post hoc analysis of final pooled phase 3 data. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Howard et al. RAISE–XT Study Team. Sustained minimal symptom expression in generalized myasthenia gravis: A 120–week post hoc analysis of RAISE–XT. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Narayanaswami et al. Treatment goals in myasthenia gravis: Expert consensus recommendations using the RAND/UCLA Appropriateness Method. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Kumar et al., Treatment characteristics and healthcare resource utilization among patients with generalized myasthenia gravis initiating rozanolixizumab in the United States. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Thompson et al. Missed opportunities for pharmacist intervention among Medicare fee–for–service beneficiaries with myasthenia gravis: a real–world claims analysis. Abstract presented at: American Academy of Neurology Annual Meeting, April 2026. Rodrigues, E., Umeh, E., Aishwarya, Navaratnarajah, N., Cole, A., & Moy, K. (2024). Incidence and prevalence of myasthenia gravis in the United States: A claims-based analysis. Muscle & nerve, 69(2), 166–171. The content above comes from the network. if any infringement, please contact us to modify.

UCB is teaming up with Chinese biotech Antengene to develop a T cell engager in Amgen’s arena, alongside bubbling competition from AstraZeneca , Merck and others. The Belgian pharma is stepping into the CD19xCD3 space in a pact with Antengene that features $60 million upfront and $20 million in near-term milestones. The biotech could collect another $1.1 billion across development, regulatory and sales milestones under the deal announced Tuesday evening. At the heart of the deal is ATG-201, which is part of Antengene’s sprawling pipeline of T cell engagers. Antengene will run Phase 1 trials of ATG‑201 and then hand over the development duties to UCB. The biotech said it will ask Chinese and Australian health regulators to approve the studies in the second quarter of this year. TCEs are a relatively newly favored modality that seeks to rid patients of autoimmune diseases or target cancer. Amgen’s marketed medicine Blincyto also goes after CD19 and CD3. By placing a bet on Antengene, UCB joins almost two dozen other Western biopharmas that have gone to China for a licensing deal so far in 2026. Antengene’s pact was one of two announced on Tuesday evening, as Sino Biopharm and Sanofi linked arms on an investigational blood cancer treatment. And many TCEs have emerged from China. This includes assets from Merck and GSK in the CD19xCD3 landscape. Earlier this week, Candid Therapeutics — a San Diego-based biotech born out of China-originated TCEs — said it would go public in a reverse merger. Antengene CEO Jay Mei said ATG-201 was designed specifically for autoimmune diseases, an apparent nod to differentiate it from other drugmakers that have repurposed TCEs initially developed for cancer into agents for autoimmune diseases. UCB chief scientific officer Alistair Henry said the move will “propel” it into the “advancing field” of bispecific TCEs. Henry said TCEs serve as a companion to UCB’s work in monoclonal antibodies and biologics. UCB markets such treatments as Bimzelx and Rystiggo. Antengene, meanwhile, markets the blood cancer medicine Xpovio in China and other regions. Antengene emerged in Shanghai in 2017, listed on the Hong Kong Stock Exchange in 2020 , and became a commercial-stage drugmaker in 2021. Outside of TCEs, the biotech also works on antibody-drug conjugates, macrophage activators, oral inhibitors and other modalities.