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Argenx announces ADAPT SERON study of Vyvgart met primary endpoint

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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