argenx Vyvgart meets primary endpoint in snMG paving path for label expansion
argenx announced positive topline data from the pivotal ADAPT SERON study of Vyvgart in AchR-Ab seronegative gMG (snMG), showing a statistically significant improvement vs. placebo (p-value=0.0068) on the primary endpoint of MG-ADL. The positive topline results do not come as a surprise, and confirm previously reported pooled analysis showing improvements in the MG-ADL score in this gMG sub-population. The company plans to file for label expansion with the FDA, and estimates the commercial opportunity for seronegative gMG could add 11K patients on top of the 17K addressable population at launch in the US. As such, this positive outcome brings the argenx closer to its target of reaching 60K MG patients by 2030. We reiterate our € 690 TP and Accumulate rating.Argenx N.V. is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. Utilizing its suite of differentiated technologies, Co. is focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need.
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