Ucb S A - UCBJY STOCK NEWS

UCB announced the presentation of eight abstracts on bimekizumab at the 2023 AAD Annual Meeting in New Orleans from March 17-21. This includes a late-breaking oral presentation detailing results from two Phase 3 studies, BE HEARD I and II, focusing on the treatment of moderate to severe hidradenitis suppurativa. The findings will help advance treatment options for chronic diseases. UCB's Executive VP emphasized the company's commitment to enhancing dermatological care. Although bimekizumab is not approved by the U.S. FDA, it has been approved in the EU for moderate to severe plaque psoriasis since August 2021.

UCB announced the publication of 24-week results from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies on bimekizumab, an IL-17A and IL-17F inhibitor, in treating active axial spondyloarthritis (axSpA). The studies met their primary and secondary endpoints, showing significant improvements in ASAS40 response rates at Week 16 and continuing to Week 24. Bimekizumab demonstrated a favorable safety profile consistent with previous studies. As an investigational product, its efficacy and safety have not been established in the U.S., and it remains unapproved by the FDA. The studies reinforce confidence in bimekizumab as a potential treatment option for axSpA.

UCB has announced that the FDA has accepted its Biologic License Application (BLA) for rozanolixizumab, aimed at treating adults with generalized myasthenia gravis (gMG). The application has been designated for Priority Review, potentially expediting the regulatory process. This follows the EMA's validation of the Marketing Authorization Application for the same drug. The BLA is supported by positive results from the Phase 3 MycarinG study, which showed statistically significant improvements in patients. UCB expects agency feedback in Q2 2023.

UCB has announced positive top-line results from two Phase 3 studies, BE HEARD I and BE HEARD II, for their investigational drug bimekizumab targeting moderate to severe hidradenitis suppurativa. Both studies met primary and key secondary endpoints, indicating significant improvements over placebo. These results will support global regulatory applications beginning Q3 2023. Bimekizumab demonstrated a consistent safety profile with no new safety signals detected. The studies also suggest that targeting both IL-17A and IL-17F could provide a promising treatment approach.

UCB announced the publication of two articles in The Lancet, detailing results from Phase 3 studies BE OPTIMAL and BE COMPLETE on bimekizumab, an investigational treatment for psoriatic arthritis. Both studies met primary and secondary endpoints, with statistically significant improvements in joint symptoms and skin clearance compared to placebo (p<0.0001). Bimekizumab's safety profile remained consistent with previous data. However, it is important to note that bimekizumab has not been approved by the U.S. FDA and its safety and efficacy remain unestablished in the U.S.

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.