UCB SA UNSP/ADR - UCBJY STOCK NEWS

UCB announced positive top-line results from the Phase 3 BE COMPLETE study, evaluating bimekizumab for active psoriatic arthritis in patients unresponsive to anti-TNF therapy. The study met its primary endpoint, showing significantly more patients achieved at least a 50% improvement in symptoms compared to placebo. All ranked secondary endpoints were also met, demonstrating improvements in physical function and skin clearance. Despite positive outcomes, bimekizumab's safety and efficacy for psoriatic arthritis remain unestablished, with regulatory applications planned for Q3 2022.

UCB has announced a definitive agreement to acquire Zogenix for US$ 26.00 per share, totaling approximately US$ 1.9 billion. The transaction includes a potential cash payment of US$ 2.00 upon EU approval of FINTEPLA® for treating Lennox-Gastaut syndrome (LGS) by December 31, 2023. This acquisition aims to enhance UCB's portfolio in rare epilepsy treatments, particularly for conditions like Dravet syndrome. Both companies' boards have unanimously approved the transaction, which is expected to close by mid-2022, pending regulatory approvals.

UCB announced positive interim results from its Phase 3 BE MOBILE 1 study assessing bimekizumab for non-radiographic axial spondyloarthritis. The primary endpoint, ASAS40 response at week 16, showed statistically significant improvement over placebo. All secondary endpoints were also met, including improvements in disease activity and spinal pain. The safety profile was consistent with prior studies, and UCB plans to submit regulatory applications in the U.S. and EU in Q3 2022. Bimekizumab is currently not approved for this indication.

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.