Argenx (ARGX) announced topline data from the pivotal ADAPT SERON study of Vyvgart. The study met its primary endpoint, demonstrating that AChR-Ab seronegative gMG patients treated with Vyvgart achieved a statistically significant and clinically meaningful improvement in MG-ADL total score compared to placebo. Based on these results, Argenx plans to submit an sBLA to the U.S. FDA seeking expansion of the Vyvgart label to include adult AChR-Ab seronegative gMG patients across all three subtypes – MuSK+, LRP4+, triple seronegative. Detailed results from the ADAPT SERON study will be presented at an upcoming medical meeting. Vyvgart was well tolerated and safe across AChR-Ab seronegative subtypes and consistent with the established safety profile in patients with AChR-Ab seropositive gMG and other indications. No new safety concerns were identified.
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