Ucb S A Stock Price, News & Analysis

UCB (UCBJY) and Domino Data Lab have announced a strategic collaboration to modernize Statistical Computing Environment (SCE) for life sciences. The partnership aims to create a unified cloud-enabled platform that integrates analytical tools like SAS, R, and Python while maintaining compliance with GxP, FDA 21 CFR Part 11, and GDPR standards.

The modernized SCE will enhance research capabilities by embedding critical metadata and workflow management for searchable data re-use, supporting UCB's scientific innovation strategy. The platform will combine Domino's cloud expertise with UCB's clinical research knowledge to accelerate drug development and enable more efficient clinical studies through advanced data analysis.

UCB (UCBJY) announced the presentation of 24 scientific abstracts at the American Academy of Neurology (AAN) meeting in San Diego, April 5-9, 2025. The research focuses on treatments for rare epilepsies (Dravet syndrome and Lennox-Gastaut syndrome), generalized myasthenia gravis (gMG), and thymidine kinase 2 deficiency (TK2d).

Key presentations include:

• Final long-term safety data for fenfluramine (FINTEPLA) in Lennox-Gastaut syndrome
• Results from rozanolixizumab (RYSTIGGO) self-administration study in gMG
• Zilucoplan (ZILBRYSQ) Phase 3 study outcomes in gMG
• Disease course data from the largest international TK2d dataset
• BRIVIACT long-term clinical outcomes in pediatric patients
• Investigation of STACCATO alprazolam for seizure management

The company will also host its inaugural US Rare Disease Connect in Neurology Annual Summit and two symposia focusing on epileptic encephalopathy and seizure emergencies.

UCB presented positive clinical data for its investigational therapy doxecitine (dC) and doxribtimine (dT) for treating thymidine kinase 2 deficiency (TK2d) at the MDA Conference 2025. The data demonstrated significant benefits in survival and motor function improvements.

Key findings show that in patients with symptom onset ≤12 years, treatment reduced death risk by 92-94% from symptom onset and 87-95% from treatment start. Additionally, 75% of patients regained at least one lost motor milestone, with 22.5% regaining four or more. Ventilatory support needs decreased, with 16.1% reducing usage and another 16.1% discontinuing support entirely.

The therapy was generally well-tolerated, with diarrhea (84.6%-90.9%) being the most common side effect. The treatment is currently under review by US FDA and EMA regulators.

UCB announced the publication of final analysis results from a long-term open-label extension study of FINTEPLA® (fenfluramine) in treating Dravet syndrome (DS) patients. The study demonstrated that FINTEPLA was generally well-tolerated with significant efficacy in reducing seizures.

Key findings include:

• 66.8% median reduction in monthly convulsive seizure frequency from baseline to end of study
• 64.2% of patients achieved ≥50% reduction in seizure frequency
• 20.3% median increase in seizure-free days
• Only 2.9% of patients discontinued due to adverse events

Common side effects included pyrexia, nasopharyngitis, and decreased appetite. Notably, no valvular heart disease or pulmonary arterial hypertension was observed. The study included both children and adults, with patients exposed to FINTEPLA for up to 3.5 years. Caregivers and investigators rated approximately 62% of patients as much/very much improved.

UCB announced promising two-year data from the BE HEARD trials for BIMZELX® (bimekizumab-bkzx) in treating moderate-to-severe hidradenitis suppurativa (HS). The data revealed significant improvements:

- 55.7% of patients with draining tunnels (DTs) at baseline had no DTs after two years of treatment
- 63.6% of patients reported no or mild skin pain, compared to 10% at baseline
- Among patients with ≥5 DTs at baseline, 41.1% achieved complete elimination of DTs

The study demonstrated sustained disease control across different patient populations, with better outcomes observed in patients who received earlier treatment. At two years, HiSCR90 was achieved by 62.6% in the lowest disease duration quartile versus 48.5% in the highest quartile. The treatment was well-tolerated with no new safety signals in the second year.

BIMZELX® (bimekizumab-bkzx) demonstrated strong long-term efficacy in treating moderate-to-severe plaque psoriasis, according to new five-year data presented at AAD 2025. The study showed that 67.7% of a subset of 153 patients achieved complete skin clearance (PASI100) at five years, while 84.9% achieved PASI90.

Key findings include sustained efficacy across different patient subgroups: high clearance rates regardless of baseline weight, and consistent results in patients with cardiometabolic comorbidities. For patients at risk of developing psoriatic arthritis, 68.7-71.6% achieved complete skin clearance at three years.

BIMZELX®, the first approved dual inhibitor of both IL-17A and IL-17F, maintained a favorable safety profile over the five-year period. The most common treatment-related adverse events were nasopharyngitis, oral candidiasis, coronavirus infection, and upper respiratory tract infection.

UCB reported strong financial performance for 2024, with revenue increasing 17% to €6.15 billion and net sales up 15% to €5.61 billion. The growth was driven by newly launched products including BIMZELX®, EVENITY®, FINTEPLA®, RYSTIGGO®, and ZILBRYSQ®, alongside solid contributions from CIMZIA® and BRIVIACT®.

Key regulatory achievements include multiple approvals for BIMZELX® across different indications and regions, including U.S. FDA approvals for psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, and hidradenitis suppurativa. The company's adjusted EBITDA reached €1.48 billion, representing 24% of revenue.

For 2025, UCB projects revenue growth to €6.5-6.7 billion, with adjusted EBITDA expected to reach 30% of revenue and Core EPS ranging from €6.80-7.40.

UCB has announced the U.S. commercial availability of a new single-injection 320 mg/2 mL administration option for BIMZELX® (bimekizumab-bkzx). The new presentation includes a prefilled syringe and autoinjector, complementing the existing 160 mg/1 mL devices.

This development follows the October 2024 approval, supported by bioequivalence studies comparing single 2 mL versus two 1 mL injections. The 320 mg dose is recommended for adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis, and moderate-to-severe hidradenitis suppurativa. A 160 mg dose remains recommended for other indications.

UCB offers patient support through BIMZELX Navigate®, providing dedicated Nurse Navigators, administration training, and copay support for eligible patients.

UCB presented new data at the 2024 American Epilepsy Society Annual Meeting focusing on epilepsy's impact and burden. Key findings include challenges faced by women of childbearing age with epilepsy in accessing relevant treatment information, with a social media study across six countries analyzing nearly 250,000 posts highlighting information gaps and anxiety issues.

The research showed that 71% of participants reported experiencing prolonged seizures, with 74% experiencing anxiety and/or depression. The company also presented data on Staccato alprazolam, an investigational drug delivery system, and new efficacy data on FINTEPLA for Lennox-Gastaut syndrome treatment. A quality-of-life survey of caregivers for individuals with developmental and epileptic encephalopathies revealed that most patients experienced disruptive symptoms affecting daily activities.