Yesterday during trading hours, the FDA flagged worsening of CIDP with Vyvgart Hytrulo as a new safety signal via a routine update to the FDA adverse event reporting system (FAERS), which sent the argenx' stock down approx. 8%. While CIDP worsening was also reported in patients switching between treatments from IVig to SCig in the PATH study, physicians navigate treatment switches carefully, and based on argenx' own post-marketing surveillance,
After contact with IR, we learned that 2Q25 has its challenges, mostly in line with 1Q. Idle time due to the ending of large contracts and ramping up of new ones was a factor and additionally, more markets encounter difficulties led by Mobility which suffers from a serious slowdown in the UK and Australia. Also, Places weakens. Resilience is doing better but not strong enough to compensate for the other GBAs. We fine-tune our estimates, expecting virtually no organic growth and no margin improve...
argenx announced its plan to advance the clinical development of ARGX-119 (muscle-specific kinase [MuSK] agonist antibody) to a registrational study in patients with congenital myasthenic syndromes (CMS) following the analysis of topline data from the phase 1b study, which showed consistent improvements through the 12-week study across multiple efficacy scores. This marks the 3rd candidate to advance to phase 3 from argenx' internal pipeline, which in our view supports the company's future growt...
argenx Advances Clinical Development of ARGX-119 in Congenital Myasthenic Syndromes Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP), argenx's collaborative discovery model June 30, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of p...
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...
Arcadis executes on its strategic roadmap, supported by a resilient global platform, disciplined M&A integration, and exposure to structural growth markets. In this note, we take a closer look at Arcadis' water activities—an increasingly important growth engine within its Resilience GBA—and assess how recent developments position the company for topline acceleration in the second half of 2025. Despite macro uncertainty, Arcadis remains on track to deliver organic growth and margin expansion, und...
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...
Feedback of the companies present at the ODDO BHF Nextcap Forum Company Country Market cap. (m) Company Country Market cap. (m) Accsys Technologies € 124 Hoffmann Green € 62 Afyren € 72 Hornbach € 1 451 Altri € 1 058 IDI € 537 AMG € 550 Implenia CHF 973 AmRest PLN 3 544 Jacquet Metals € 494 Arcure € 29 Kloeckner & Co € 653 Arverne 194 Knaustabbert € 144 Austriacard Holdings € 188 Lna Santé € 270 Bastide € 218 Medincell € 398 Befesa € 1 116 Nacon € 63 CAF € 1 649 N...
Our 14th edition of the ODDO BHF Nextcap Forum took place on 11 June in Paris, and on 12 June virtually. 96 companies and 170 investors were present for more than 700 meetings organized. Overall, we noted a still cautious tone from companies, with limited visibility on a solid rebound in a persistently uncertain market environment (geopolitical situation, US politics, etc.), even if there are some signs of recovery and certain sectors remain very well positioned (leisure, energy, defence). At th...
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