ARGX · argenx SE

argenx presented compelling Phase 3 data from ADAPT OCULUS demonstrating VYVGART as the first biologic to significantly improve symptoms in ocular MG patients (p=0.012 on MGII PRO ocular scores, p=0.018 PRO+PE), addressing an underserved population and forming the basis for a planned sBLA to FDA. This expands VYVGART's potential beyond approved gMG into a subtype affecting key symptoms like diplopia and ptosis. Similarly, ADAPT SERON results in MuSK+, LRP4+, and triple seronegative gMG patients showed rapid, cycle-dependent efficacy improvements on MG-ADL and QMG scores, reinforcing broad utility across antibody statuses; the sBLA here has priority review with a PDUFA date of May 10, 2026, offering near-term label expansion potential. In CIDP, ADHERE post hoc analysis highlighted VYVGART Hytrulo's early benefits in treatment-naïve patients (87.5% response rate, 39.5-day median), filling evidence gaps and supporting first-line positioning, while real-world data showed high IVIg switch success (85.7%). ADAPT Jr data in adolescents further validates pediatric applicability. Pipeline updates include Phase 3 CIDP designs for empasiprubart (head-to-head vs IVIg and vs placebo) and sustained adimanebart benefits in DOK7 CMS, underscoring argenx's neuromuscular leadership and multiple catalysts for VYVGART franchise growth.