Empasiprubart (ARGX-117) - (EMPASSION)

September 29, 2026: argenx SE (Euronext/NASDAQ: ARGX) said it will present portfolio data at the 2026 AANEM Annual Meeting and MGFA Scientific Session (September 29–October 2, Orlando).

VYVGART/Hytrulo (efgartigimod) in MG: In Phase 3 ADAPT OCULUS ocular MG, benefit deepened after two additional cycles beyond the placebo-controlled period, with mean MGII ocular score changes improving from -4.5 to -6.8 in AChR-Ab-positive patients and from -2.7 to -4.5 in triple-seronegative patients. In generalized MG, one-year ADAPT SERON data in anti-AChR antibody-negative patients showed about 5-point mean MG-ADL improvement maintained through Week 52 with consistent safety. A U.S. real-world analysis of >1,100 MG patients found greater benefit with earlier treatment; patients treated within 1 year of diagnosis had a 4.7-point mean MG-ADL reduction over 3 months versus 3.5 points when treated >3 years after diagnosis, and 50% reached minimal symptom expression (p<0.001).

VYVGART Hytrulo in CIDP: ADHERE/ADHERE+ interim data showed consistent safety beyond 5 years; about 40% of responders reached INCAT 0/1. A post hoc analysis found a 71.5% lower relative risk of grip-strength deterioration (HR 0.285; p<0.001). In a Phase 4 switch study, 87% remained on Hytrulo through 12 weeks after a 1-week transition from IVIg. Among treatment-naïve patients, 87.5% achieved confirmed clinical improvement and 44.4% improved by at least 2 INCAT points.

Pipeline: Phase 2 ARDA+ data for empasiprubart in MMN showed sustained clinical benefit and consistent safety. Phase 1b adimanebart data in DOK7-congenital myasthenic syndrome showed in-clinic and real-world walking improvements measured by digital gait outcomes.