Argenx SE Brings Neuromuscular Leadership to AAN 2026 with New Data Supporting Broader VYVGART Use Across MG and CIDP

argenx SE announced the presentation of new data for VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) at the 2026 American Academy of Neurology (AAN) Annual Meeting in Chicago from April 18-22, 2026. Presentations will also highlight new data for adimanebart in congenital myasthenic syndromes (CMS) and argenx?s broader neuromuscular pipeline, including Phase 3 programs evaluating empasiprubart in CIDP. Advancing VYVGART Across Broadest Set of MG Populations: The Phase 3 ADAPT OCULUS study showed that VYVGART is the first and only biologic treatment demonstrating efficacy specifically in patients living with ocular myasthenia gravis (oMG).

The study met its primary endpoint (p=0.012), showing oMG patients treated with VYVGART demonstrated statistically significant improvement from baseline in the Myasthenia Impairment Index (MGII) Patient-Reported Outcome (PRO) ocular scores at Week 4 versus placebo. These improvements were supported by the combined patient-reported outcome and physician examination (PRO+PE) assessment (p = 0.018), showing consistent and clinical improvement in key ocular symptoms such as diplopia (double vision) and ptosis (drooping of the upper eyelids). Results will be used to support a planned supplemental Biologics License Application (sBLA) submission to the U.S. Food and Drug Administration (FDA) to expand the label into oMG.

The Phase 3 ADAPT SERON trial showed patients treated with VYVGART ? across MuSK+, LRP4+, and triple seronegative generalized myasthenia gravis (gMG) ? experienced rapid improvements and increasingly pronounced efficacy with each additional cycle as measured by Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores in the open-label extension.

These data further support VYVGART?s efficacy and safety across gMG patients regardless of antibody status. A sBLA for this patient population has been granted priority review by the FDA with a target action date of May 10, 2026.Results from ADAPT Jr showed adolescent participants (ages 12-17) demonstrated consistent and repeatable MG-ADL improvements across treatment cycles, with 72.7% in cycle one and 80% in cycle two achieving minimal symptom expression (MSE). Enrollment of a younger pediatric cohort is ongoing.

Expanding the Role of VYVGART in CIDP: An ADHERE post hoc analysis supports the potential for earlier, first-line use of VYVGART Hytrulo in CIDP, with 87.5% of treatment-naïve patients treated with VYVGART Hytrulo achieving confirmed early clinical improvement and a median time to response of 39.5 days. These findings address an important evidence gap in patients historically underrepresented in CIDP trials.Real-world physician insights from an assessment of 225 patients showed that 85.7% of the 91 patients who attempted to switch from IVIg to VYVGART Hytrulo were successful, defined by patients demonstrating clinical improvement or maintaining stability without tolerability issues. Switching was driven by clinical and practical considerations, including prior treatment dissatisfaction or lack of efficacy, IVIg-related safety or tolerability concerns, poor venous access, adherence challenges, and patient preference.

Progressing Neuromuscular Pipeline: Two Phase 3 CIDP studies highlight argenx?s commitment to advancing innovative treatment options across all adult CIDP patient populations with empasiprubart. Researchers will present trial designs for EMVIGORATE, a head-to-head study versus IVIg, and EMNERGIZE, which evaluates empasiprubart versus placebo.Follow-up results from the Phase 1b study of adimanebart, a MuSK agonist antibody, in DOK7 CMS showed that improvements in key QMG components and six-minute walk test performance (total distance and cadence), observed during the 12-week treatment period, were generally maintained throughout the 30-week treatment-free follow-up period. These results build on previously presented proof-of-concept data and further support adimanebart in this neuromuscular disorder.