Ucb S A Stock Price, News & Analysis

UCB announced positive interim results from the Phase 3 BE MOBILE 2 study evaluating bimekizumab for adults with active ankylosing spondylitis. The study met its primary endpoint, showing significant improvements in patient-reported outcomes, including ASAS40 response at week 16. All ranked secondary endpoints were also met, reinforcing the drug's efficacy. The safety profile remained consistent with previous studies, with no new safety signals identified. Bimekizumab is not yet approved for this indication. Results will be further disseminated at medical conferences and in peer-reviewed journals.

UCB announced the presentation of new data from its seizure treatment portfolio (BRIVIACT, NAYZILAM, VIMPAT) at the 75th American Epilepsy Society Annual Meeting in Chicago, from December 3-7, 2021. The data showcases advancements in epilepsy management, including efficacy studies for children and adolescents. Furthermore, UCB will host a symposium to address health inequities affecting Hispanic patients. The FDA has recently approved expanded indications for BRIVIACT and VIMPAT, now including patients as young as one month.

UCB has formed a global co-development and co-commercialization agreement with Novartis for UCB0599, a small molecule alpha-synuclein misfolding inhibitor currently in Phase 2 development, and UCB7853, an anti-alpha-synuclein antibody pending Phase 1 completion. UCB will receive an upfront payment of US$150 million, with potential total payments nearing US$1.5 billion linked to regulatory and sales milestones. UCB will handle European and Japanese commercialization while Novartis will manage operations in the US and other regions. This agreement does not affect UCB's 2021 financial guidance.

UCB announced positive interim results from the Phase 3 BE OPTIMAL study, which evaluated bimekizumab for treating active psoriatic arthritis in biologic naïve adults. The study met its primary endpoint, with more patients achieving a 50% improvement in symptoms compared to placebo at week 16. Significant improvements were also noted in secondary endpoints, including physical function and skin clearance. The safety profile was consistent with previous studies, with no new safety signals. Full results will be presented at a medical conference. Bimekizumab is under review by the FDA for plaque psoriasis.

On November 5, 2021, UCB presented significant data on its investigational drugs, bimekizumab and CIMZIA, during the ACR Convergence 2021 virtual congress. Eleven abstracts showcased findings, with a focus on bimekizumab's potential in psoriatic arthritis and ankylosing spondylitis. The data indicated long-term safety and efficacy, maintaining clinical outcomes over three years. CIMZIA’s three-year results for nr-axSpA were also highlighted, showing no new safety signals. Bimekizumab is currently under FDA review for treating moderate to severe plaque psoriasis.

Sharecare (Nasdaq: SHCR) announced a presentation with UCB at the CNS Summit on Nov. 8, focusing on participant empowerment in clinical research. Led by Dr. Nirav R. Shah, the session will discuss leveraging smartphone technology for decentralized studies, yielding real-world findings. Sharecare's Smart Omix initiative aims to enhance data integrity and representation in research. A recent study showed 90% of participants would use an AI model for symptom prediction, highlighting the initiative's impact on managing myasthenia gravis.

A new research analysis by UCB focuses on the lived experience of myasthenia gravis (MG), detailing patient insights published in Neurology and Therapy. Conducted by a Patient Council of nine advocates from Europe and the U.S., the study highlights significant themes affecting MG patients, including treatment inertia, communication gaps with physicians, and the emotional burden of the disease. Despite MG's rarity, with 8-10 cases per million annually, the incidence is rising due to better diagnostics. The study encourages improved dialogue and understanding between patients and healthcare providers.

UCB, on World Osteoporosis Day 2021, announced a strategic out-licensing of its AI fracture identification technology, BoneBot, to ImageBiopsy Lab. This collaboration aims to integrate AI into clinical practice by 2023, enhancing the detection of asymptomatic spinal fractures via CT scans. Osteoporosis affects around 200 million people globally, leading to 9 million fragility fractures annually. This partnership reflects UCB's commitment to addressing the needs of osteoporosis patients and improving healthcare outcomes through innovative technology.

UCB announced it could not complete the FDA review of the Biologics License Application for bimekizumab by the October 15, 2021 PDUFA date due to COVID-19 travel restrictions affecting necessary facility inspections. The BLA remains under review, and UCB is in contact with the FDA to schedule inspections. Bimekizumab received marketing authorization in the EU and Great Britain in August 2021 and remains under regulatory review in several other countries. UCB's financial guidance for 2021 and 2025 remains unchanged.