Ucb S A Stock Price, News & Analysis

UCB will present 14 abstracts at the 2024 AANEM Annual Meeting and MGFA Scientific Session, showcasing new data for its gMG treatments. Key highlights include:

- Long-term safety and efficacy data for ZILBRYSQ® (zilucoplan) and RYSTIGGO® (rozanolixizumab-noli)

- Results from the RAISE-XT trial for zilucoplan, including 120-week interim analysis

- Post hoc analyses from the Phase 3 MycarinG trial for rozanolixizumab

- Data on switching to subcutaneous zilucoplan from IV complement inhibitors

- Insights on corticosteroid sparing and changes in immunosuppressant therapy

The presentations emphasize UCB's leadership in neuromuscular research and commitment to advancing gMG treatment. UCB will also host an industry-sponsored session on gMG treatment choices.

UCB has announced the initiation of BE BOLD, a Phase 3b head-to-head study comparing BIMZELX® (bimekizumab) and SKYRIZI® (risankizumab) in adults with active psoriatic arthritis (PsA). This study is the first to evaluate the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor in PsA. BE BOLD will use the American College of Rheumatology 50 (ACR50) at Week 16 as its primary endpoint. The study will include around 550 adults with active PsA, who are either biologic treatment naïve or have had an inadequate response to one TNFi. Top-line results are expected in 2026.

UCB announced two-year data from Phase 3 studies BE HEARD I and II, evaluating BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe hidradenitis suppurativa (HS). Results showed maintained improvements over two years:

- At Week 96, 85.4% of patients achieved HiSCR50, 77.1% achieved HiSCR75, and 44.2% achieved HiSCR100

- Improvements in disease severity, reductions in draining tunnel count, and quality of life were maintained

- Approximately 1 in 3 patients reported minimal or no impact on health-related quality of life

BIMZELX was generally well-tolerated with no new safety signals. The data was presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

UCB presented new 4-year data for BIMZELX® (bimekizumab-bkzx) in moderate-to-severe plaque psoriasis at EADV 2024. Key findings include:

1. Maintenance of response: 87.9% of PASI90 responders and 74.2% of PASI100 responders at Year 1 maintained their response at Year 4.

2. Switching efficacy: Over 70% of patients who switched to BIMZELX after inadequate response to adalimumab, secukinumab, or ustekinumab achieved and maintained PASI90 for up to four years.

3. BE UNIQUE study: A Phase 3b study exploring the fast onset, high level, and durability of clinical and molecular responses in patients with psoriatic disease.

The data demonstrate long-term efficacy of BIMZELX in maintaining skin clearance for psoriasis patients.

UCB announced that the U.S. FDA has approved BIMZELX® (bimekizumab-bkzx) for treating adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA), and active ankylosing spondylitis (AS). BIMZELX is the first and only IL-17A and IL-17F inhibitor approved in the U.S. for treating four chronic immune-mediated inflammatory diseases.

The approvals are supported by Phase 3 studies showing statistically significant improvements vs. placebo at Week 16 in joint and skin symptoms for PsA, and signs and symptoms for nr-axSpA and AS. These improvements were sustained to Week 52. The recommended dosage is 160 mg by subcutaneous injection every four weeks for all three indications.

This expansion follows BIMZELX's first U.S. approval in October 2023 for moderate-to-severe plaque psoriasis in adults. UCB aims to enable affordable access to BIMZELX for all patients who need it.

UCB, a global biopharmaceutical company, announced its inaugural Hidradenitis Suppurativa (HS) Summit to be held on August 17, 2024, in Atlanta. The event aims to provide a community forum for shared dialogue about HS, an underdiagnosed and often misdiagnosed dermatologic disease. Dr. Sandra Lee, known as 'Dr. Pimple Popper', will attend and speak at the summit.

The summit will feature expert- and patient-led panel discussions focusing on the HS journey and various aspects of living with the condition. It amplifies UCB's Make HStory program, a disease-state education campaign providing resources for HS patients and dermatologists. The event will bring together patients, caregivers, advocacy leaders, and healthcare providers to advance understanding of HS treatment and unmet needs.

UCB partners with Emmy winner Ben Decter and Tony nominee Kristin Hanggi for the world premiere musical 'It's All Your Fault, Tyler Price!' The musical, focusing on epilepsy awareness, will run from November 7 to December 15, 2024, at The Hudson Theatre in Los Angeles.

The story follows Jackson, a middle school boy who stages a musical to avoid expulsion after punching a classmate who mocked his sister with epilepsy. The cast includes CJ Eldred, Jenna Pastuszek, and Faith Graham. Tickets go on sale August 1, 2024.

UCB, a global biopharmaceutical company, supports this production as part of its commitment to epilepsy awareness and patient care. The musical aims to shed light on Lennox-Gastaut Syndrome (LGS) and other epilepsy-related challenges faced by patients and their families.

UCB announced that Epilepsia published findings from an analysis on FINTEPLA® (fenfluramine) evaluating its effectiveness in reducing generalized tonic-clonic seizures (GTCS) and tonic-clonic seizures (TCS) among patients with developmental and epileptic encephalopathies (DEEs). The study, adhering to PRISMA-ScR guidelines, included 14 eligible studies out of 422, identifying 421 unique patients with conditions like Dravet syndrome and Lennox-Gastaut syndrome. Results showed a median reduction in seizure frequency from 47.2% to 100%, with 72% of patients achieving a ≥50% reduction, and 54% achieving a ≥75% reduction. The promising results align with previous FINTEPLA clinical trial data, indicating its potential in managing severe seizures in DEEs.

UCB presented results from three studies on CIMZIA® (certolizumab pegol) at the European Congress of Rheumatology (EULAR) 2024.

The CHERISH study indicated pregnant women with chronic immune-mediated diseases could maintain their dosing regimen of certolizumab pegol throughout pregnancy, showing stable blood plasma concentrations similar to non-pregnant women.

Another study found that rheumatoid factor (RF) antibodies bind to Fc-containing TNFis but not to certolizumab pegol, suggesting molecular insights for personalized rheumatoid arthritis (RA) treatments.

Additionally, the REALISTIC trial's post-hoc analysis revealed that high RF patients with RA responded similarly to certolizumab pegol over time, regardless of RF levels, even in TNFi inadequate responders.

These findings underscore the potential for more personalized treatment approaches in patients with high unmet needs.