Ucb S A Stock Price, News & Analysis

UCB presented 21 scientific studies, including 7 late-breaking findings, at the 76th American Epilepsy Society (AES) Annual Meeting in Nashville, highlighting their commitment to epilepsy care. Key updates include data on the efficacy and safety of UCB's anti-seizure medications: BRIVIACT®, FINTEPLA®, VIMPAT®, and NAYZILAM®. Topics covered include real-world treatment outcomes, health equity, and cognitive effects in pediatric patients. UCB aims to advance the understanding of epilepsy, particularly in underserved populations, through ongoing research and educational initiatives.

UCB announced positive results from a Phase 3 open-label extension study of FINTEPLA (fenfluramine) for treating Lennox-Gastaut syndrome (LGS). Over a median duration of 15 months, FINTEPLA significantly reduced the frequency of various seizure types. Key findings include a 28.6% overall reduction in seizures associated with a drop, and a 50.5% reduction by month 15. Additionally, no valvular heart disease or pulmonary arterial hypertension cases were reported, reinforcing FINTEPLA's safety profile. This medication is FDA-approved for patients aged 2 and above.

UCB announced the acceptance of its New Drug Application (NDA) for zilucoplan by the U.S. FDA, intended for treating generalized myasthenia gravis (gMG) in adults who are acetylcholine receptor antibody positive (AChR-Ab+). This follows the European Medicines Agency's validation of its Marketing Authorization Application (MAA) for the same treatment. Both applications are based on the pivotal Phase 3 RAISE study, showing significant improvements in key outcomes. UCB anticipates feedback from regulatory bodies in Q4 2023.

UCB presented late-breaking 52-week data from three Phase 3 studies of bimekizumab for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) at ACR Convergence 2022. Results showed sustained clinical responses for patients treated with bimekizumab, with significant improvements in joint and skin clearance. The studies reported a consistent adverse event profile and no new safety signals. Key findings include ACR50 response at 54.5% and complete skin clearance in 60.8% of PsA patients. Bimekizumab is not FDA-approved for any indication in the U.S.

UCB is set to present 15 abstracts at ACR Convergence 2022 in Philadelphia from November 10-14, focusing on its rheumatology portfolio. Notably, the presentation includes late-breaking 52-week data for bimekizumab in treating psoriatic arthritis and axial spondyloarthritis. This data will be shared through four oral presentations and eight e-posters, underscoring UCB's dedication to advancing treatment standards. Bimekizumab is still under investigation and not yet approved by the FDA. CIMZIA® data will also be presented, highlighting its use in active axial spondyloarthritis.

UCB announces its Atlanta Warehouse as the first dually certified WELL Platinum and LEED Gold pharmaceutical project globally. This signifies UCB's commitment to sustainability and employee well-being. The building supports innovative work environments, having achieved notable sustainability metrics, including a 30% reduction in energy consumption and diverting 85% of waste during construction. UCB aims for a 35% reduction in CO2 emissions by 2030. This project underscores UCB's dedication to creating a healthier workplace and minimizing environmental impact in the Atlanta community.

UCB presented new data on its investigational treatments for generalized myasthenia gravis (gMG) at the AANEM annual meeting. Key studies included the Phase 3 MycarinG study for rozanolixizumab and the RAISE studies for zilucoplan. Rozanolixizumab showed significant efficacy in MuSK-Ab+ gMG patients, with improvements in MG-ADL scores. Zilucoplan demonstrated a favorable safety profile and ongoing efficacy in long-term studies. Both treatments are not yet approved, and UCB plans EU, Japan, and U.S. regulatory submissions later this year.

UCB announced three-year data from the BE BRIGHT open-label extension study at the EADV Congress, showcasing the long-term efficacy of bimekizumab for moderate to severe plaque psoriasis. Key findings reveal that over 82% of patients maintaining complete skin clearance (PASI 100) and approximately 94% achieving low disease activity (PASI ≤2) after 16 weeks retained these results up to three years. Safety data from pooled Phase 2 and 3 trials indicated that bimekizumab was generally well tolerated, with no new safety signals reported, reinforcing its positive profile in treating psoriasis.

UCB announced its participation in the 31st European Academy of Dermatology and Venereology Congress in Milan, showcasing 20 abstracts focused on psoriasis and psoriatic arthritis. Key findings include three-year data from the BE BRIGHT study on bimekizumab for moderate to severe plaque psoriasis, highlighting long-term efficacy and safety. While bimekizumab has secured EU and other international approvals, it remains investigational in the U.S., with no FDA endorsement yet. UCB aims to elevate care standards for dermatological diseases through innovative therapies.