Apr. 19 at 5:36 PM
$ARGX Argenx announces Phase 3 Adapt Oculus study met primary endpoint
argenx announced the presentation of new data for Vyvgart in myasthenia gravis and chronic inflammatory demyelinating polyneuropathy 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. 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. The study met its primary endpoint, showing oMG patients treated with Vyvgart demonstrated statistically significant improvement from baseline in the Myasthenia Impairment Index Patient-Reported Outcome ocular scores at Week 4 versus placebo.
These improvements were supported by the combined patient-reported outcome and physician examination assessment, showing consistent and clinical improvement in key ocular symptoms such as diplopia and ptosis. 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 - experienced rapid improvements and increasingly pronounced efficacy with each additional cycle as measured by Myasthenia Gravis Activities of Daily Living and Quantitative Myasthenia Gravis (QMG) scores in the open-label extension. Results from ADAPT Jr showed adolescent participants 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. Enrollment of a younger pediatric cohort is ongoing.
