Argenx receives review from FDA for VYVGART in seronegative gMG
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Argenx announced that the FDA has accepted for priority review its supplemental biologics license application for VYVGART, aimed at treating adults with acetylcholine receptor antibody seronegative generalized myasthenia gravis (gMG). The target action date is set for May 10, 2026. Chief Medical Officer Luc Truyen emphasized the need for improved treatment options for these patients. The application is backed by positive results from the phase 3 ADAPT SERON study, which demonstrated significant improvements in daily living activities for patients treated with VYVGART, with a favorable safety profile.
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