UCB announced positive Phase 3 results for Fintepla in treating CDKL5 deficiency disorder (CDD), a rare and severe early-onset epileptic condition with limited treatment options. The randomized, placebo-controlled study in patients aged 1–35 met its primary and secondary endpoints, showing a significant reduction in countable motor seizures and a favourable safety profile. UCB plans to announce the full dataset at an upcoming conference and seek regulatory approval promptly. This marks Fintepla'...
We are 28% above cons. US Bimzelx sales for H125 with Bimzelx sales momentum being the most important factor for the UCB investment thesis. Unlike the early days for US obesity, this is one of the most complex dynamics we have contended with when forecasting sales. There are multiple unknowns that we have sought to model (net price per scrip, net avg. price by indication, 2024 volume, volume growth by payer & incremental discounts to unlock that volume growth). As a result of our analysis, we in...
argenx announced that the European Commission (EC) approved Vyvgart SC for the treatment of adults with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins, which comes in line with expectations following the positive CHMP opinion issued in April 2025. We anticipate a steady country by country EU launch, and continue to expect the US to remain the main driver for Vyvgart's commercial launch. We currently estimate approx. $ 1.1bn in peak sales for CI...
argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDPApproval based on ADHERE clinical trial, the largest study of CIDP patients to dateFirst novel mechanism of action for CIDP treatment in more than 30 years June 20, 2025, 7:00 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the liv...
In general, a weaker USD has a negative impact on Benelux stocks, particularly for companies with significant exports to the US. In this note we selected a list of companies with high US export exposure and we examine the potential impact on FY25 earninings. On top of the weak dollar, rising trade tensions or the introduction of tariffs further harm Benelux exporters. As the dollar depreciates against the euro, European goods become costlier for American consumers. At the same time, revenues ear...
UCB has announced plans to build a new state-of-the-art biologics manufacturing facility in the US, which today accounts for 55% of its revenues. The investment, estimated at $ 2bn over 6–7 years, is expected to generate a $ 5bn economic impact, including 300 permanent and > 500 construction jobs. This move aligns UCB with other major pharma players expanding US operations and may help mitigate risks from potential US import tariffs on pharmaceuticals. Additionally, UCB will strengthen its partn...
UCB and Biogen presented additional Phase 3 data showing that dapirolizumab pegol (DZP, anti-CD40L) significantly improves fatigue and disease activity in patients with moderate-to-severe systemic lupus erythematosus (SLE). Beyond the positive topline readout in Nov '24, DZP showed superior results over standard care in multiple fatigue and disease remission measures. Accumulate/€214 TP confirmed.
At EULAR 2025, UCB presented three-year data for Bimzelx, demonstrating sustained efficacy and inflammation control in psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). In PsA, both biologic-naïve (53.2%) and TNFa-refractory patients (55.2%) maintained strong ACR50 responses and showed high rates of joint and skin symptom resolution. In axSpA, patients with both radiographic and non-radiographic forms sustained ASAS40 responses and low disease activity. These results highlight Bimze...
argenx announced the presentation of POC results from phase 2 studies evaluating Vyvgart in Sjogren's disease (SjD) and idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology (EULAR), being held 11-15 June. We believe the POC data, showing improvements in disease activity and functional outcomes support the continued development of Vyvgart, with phase 3 trials currently ongoing in both indications. In addition, Vyvgart was granted FDA fast track designation...
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