Argenx Targets FDA Label Expansion After Vyvgart Trial Success

Woman, Scientist, MedicalResearch

Argenx SE (NASDAQ:ARGX) released topline data on Monday from the pivotal Phase 3 ADAPT SERON study of Vyvgart (IV: efgartigimod alfa-fcab).

Part A of the trial randomized participants (1:1) to receive 4 once-weekly infusions of efgartigimod IV or placebo, followed by a 5-week follow-up and primary analysis. Part B was an open-label extension: participants received 2 fixed cycles of 4 once-weekly efgartigimod infusions (4-week interval between cycles); from cycle 3 onward, additional cycles could be started ≥1 week after the last administration of the previous cycle, based on clinical status.