Also known as M281.
Phase 2 data show FcRn blocker nipocalimab reduced SLE activity versus placebo, with larger benefit in autoantibody‑positive patients and no new safety signals.
FDA granted Priority Review to nipocalimab sBLA for warm autoimmune hemolytic anemia after Phase 2/3 ENERGY showed durable hemoglobin responses and fatigue improvement; review ~6 months.
