News Related to Anti-Acetylcholine Receptor Antibody

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Regeneron Receives FDA Priority Review for Garetosmab in FOP, EMA Review for Cemdisiran in gMG

Jun 22, 2026

Regeneron announced FDA and EMA review acceptance for cemdisiran in generalized myasthenia gravis and FDA priority review acceptance for garetosmab in fibrodysplasia ossificans progressiva. The garetosmab BLA is supported by Phase 3 OPTIMA trial data showing 94% and 90% reductions in new bone lesions.

argenx Reports $1.3B Q1 2026 Revenue, PDUFA Date Set for May 10 in Seronegative gMG

May 07, 2026

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.