New Phase 3 data show VYVGART’s efficacy across multiple myasthenia gravis subtypes and early benefit in CIDP, supporting broader use and ongoing regulatory review.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
argenx today announced new clinical data for VYVGART® (efgartigimod alfa) and VYVGART Hytrulo™ (efgartigimod alfa/hyaluronidase) at the American Academy of Neurology (AAN) Annual Meeting 2026, highlighting broader efficacy across myasthenia gravis (MG) subtypes and early clinical benefit in chronic inflammatory demyelinating polyneuropathy (CIDP).
In ocular MG, the Phase 3 ADAPT OCULUS study (NCT06558279) showed that subcutaneous VYVGART Hytrulo significantly improved Myasthenia Gravis Impairment Index (MGII) ocular scores at Week 4 versus placebo (p=0.012). A key secondary endpoint combining patient-reported and physician-assessed outcomes was also met (p=0.018), with clear improvements in ptosis and diplopia. These results support a planned supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA).
In generalized MG (gMG), the Phase 3 ADAPT SERON trial (NCT06298552) demonstrated improvements in MG-ADL and Quantitative Myasthenia Gravis (QMG) scores in patients without AChR antibodies, including MuSK+, LRP4+, and triple seronegative subtypes. Treatment effects increased across successive cycles in the open-label extension, supporting use regardless of antibody status. The corresponding regulatory submission is under FDA priority review, with a target action date of May 10, 2026.
The Phase 3 ADAPT Jr trial in adolescents aged 12–17 years with gMG showed consistent and repeatable clinical responses, with a high proportion achieving minimal symptom expression across treatment cycles. Enrolment is ongoing in younger pediatric populations.
In CIDP, a post hoc analysis of the ADHERE study indicated potential for earlier use of subcutaneous VYVGART Hytrulo. Among treatment-naïve patients, 87.5% achieved early clinical improvement, with a median time to response of 39.5 days. Real-world data showed that 85.7% of patients who switched from IVIg achieved improvement or maintained disease stability, with no new tolerability signals.
argenx also highlighted ongoing Phase 3 CIDP programs with empasiprubart, including EMVIGORATE, a head-to-head study versus IVIg, and EMNERGIZE, a placebo-controlled trial. Follow-up data from a Phase 1b study of adimanebart in DOK7 congenital myasthenic syndromes showed sustained improvements in motor function during a 30-week treatment-free period.
“Together, these data reinforce our efforts to broaden VYVGART’s applicability across MG subtypes and highlight early clinical benefits in CIDP,” said Luc Truyen, Chief Medical Officer of argenx.
“Expanding antibody-agnostic treatment options across diverse MG populations has the potential to improve daily functioning and quality of life,” added Samantha Masterson, Chief Executive Officer of the Myasthenia Gravis Foundation of America.
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About the Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.