Ucb S A Stock Price, News & Analysis

UCB announced its participation in the 75th American Academy of Neurology Annual Meeting from April 22-27, 2023, showcasing its neurology portfolio. The company will present 12 abstracts, including two oral presentations on treatments for generalized myasthenia gravis (gMG) and epilepsy syndromes like Lennox-Gastaut syndrome (LGS). Highlights include findings from the MycarinG and RAISE studies, detailing efficacy and safety of investigational treatments rozanolixizumab and zilucoplan for adults with gMG. UCB will also feature analyses on BRIVIACT and FINTEPLA, focusing on their impacts on seizure frequency and cognitive functions. Key sessions include a panel on seizure emergencies and cluster identification in adults, emphasizing UCB's commitment to improving patient outcomes in neurology.

UCB announced that the U.S. Drug Enforcement Administration has descheduled FINTEPLA oral solution, removing it from controlled substances classification effective immediately. This allows prescribers to issue prescriptions for a full year instead of six months, enhancing patient access to treatment for Dravet syndrome and Lennox-Gastaut syndrome. The company will update relevant state compendia accordingly. FINTEPLA, FDA-approved for patients aged 2 and older, is developed by UCB following their acquisition of Zogenix, Inc. in March 2022. The descheduling is expected to ease prescription processes for patients and caregivers, potentially increasing the drug’s usage for those in need.

UCB reported promising results from two Phase 3 studies (BE HEARD I and II) on bimekizumab, an IL-17A and IL-17F inhibitor, for treating moderate to severe hidradenitis suppurativa (HS). At week 16, patients receiving bimekizumab experienced statistically significant improvements in HS symptoms compared to placebo, with HiSCR50 responses at 47.8% and 52.0% in BE HEARD I and II, respectively. The efficacy persisted to week 48, with over 75% of patients achieving HiSCR50. UCB plans to submit global regulatory applications for bimekizumab in HS in Q3 2023. No new safety signals were noted, with common adverse events including hidradenitis and oral candidiasis.

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.