Also known as: FcRn
FDA approved Imaavy (nipocalimab-aahu), the first treatment for warm autoimmune hemolytic anemia; 24% achieved durable hemoglobin responses vs 8% with placebo. Rilzabrutinib earned Breakthrough status.
FDA approved Viridian's Lumvoa (veligrotug-vvze) for thyroid eye disease on June 26, 2026; immediate U.S. launch followed. Q2 2026 cash stood at $982 million, and elegrobart BLA submission is on track for Q1 2027.
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
