argenx Presents New VYVGART Data Across MG and CIDP
AMSTERDAM, Netherlands — September 29, 2026 — argenx SE announced new clinical and real-world data for VYVGART (efgartigimod alfa) and VYVGART Hytrulo at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session. The presentations include data supporting continued treatment benefits in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), alongside clinical updates for empasiprubart and adimanebart. In MG, new analyses showed deepening improvement in ocular disease, sustained efficacy in patients without detectable anti-AChR antibodies and greater real-world improvements among patients who started VYVGART earlier in their disease course. In CIDP, long-term data supported sustained safety and efficacy with VYVGART Hytrulo, while a Phase 4 study evaluated direct transition from IVIg.
VYVGART Data Expand Evidence Across MG Populations
New Phase 3 ADAPT OCULUS data showed that ocular MG improvements continued to deepen with additional VYVGART treatment cycles. After two treatment cycles beyond the placebo-controlled period, mean MGII patient-reported ocular scores improved from -4.5 to -6.8 points in AChR-antibody-positive patients and from -2.7 to -4.5 points in triple-seronegative patients. In the ADAPT SERON study, patients with generalized MG without detectable anti-AChR antibodies maintained approximately a 5-point mean improvement in MG-ADL through Week 52. Real-world evidence from more than 1,100 U.S. patients also showed improvements in MG-ADL scores, steroid burden and exacerbation rates across patient subgroups. Patients who began VYVGART within one year of diagnosis had a mean 4.7-point MG-ADL reduction during the first three months, compared with 3.5 points among those treated more than three years after diagnosis.
Long-Term VYVGART Hytrulo Data Support CIDP Treatment
Long-term analyses of the ADHERE and ADHERE+ studies showed a consistent safety and efficacy profile for VYVGART Hytrulo in CIDP, with follow-up extending beyond five years. Approximately 40% of responding participants reached an INCAT score of 0 or 1 during the extension period, indicating little to no functional disability on that measure. A post hoc analysis also found that VYVGART Hytrulo reduced the relative risk of grip-strength deterioration by 71.5% compared with the study comparator, with changes in grip strength detected earlier than established disability measures. In a Phase 4 switch study, 87% of patients remained on VYVGART Hytrulo through Week 12 after transitioning from IVIg one week after their final IVIg dose. Separately, longitudinal ADHERE and ADHERE+ analyses found that 87.5% of treatment-naïve patients achieved confirmed clinical improvement, with 44.4% of those patients improving by at least two INCAT points by Week 36.
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argenx Advances Complement and Neuromuscular Pipeline
Beyond VYVGART, argenx presented new data supporting its broader neuromuscular development strategy. Phase 2 ARDA+ results for empasiprubart in multifocal motor neuropathy showed sustained clinical benefit and consistent safety, complemented by translational data examining pathway-selective complement blockade. Empasiprubart is a monoclonal antibody targeting C2 to inhibit the classical and lectin complement pathways upstream of C3 and C5. The company also presented Phase 1b data for adimanebart in adults with DOK7-congenital myasthenic syndrome, including digital gait measurements and qualitative patient-reported information indicating improvements in walking performance. Together, the data expand argenx’s development programs across rare neuromuscular diseases while VYVGART continues to generate evidence across MG and CIDP populations. The company is using these clinical, long-term and real-world findings to evaluate broader treatment opportunities and new mechanisms across its neuromuscular pipeline.
Source: argenx press release
