Sutimlimab is the first approved therapy for CAD, with the first approvals taking place in the US, EU, and Japan in 2022.14, 15, 16 The phase 3, CARDINAL study (Part A, 26 weeks) showed sutimlimab rapidly halted haemolysis, improved haemoglobin (Hb) levels, and reduced fatigue in patients with CAD with a recent history of transfusion13,17; the 2-year extension (Part B) demonstrated that the effects of sutimlimab were sustained but that disease activity reoccurs following treatment cessation.18 The gene discussed is GSTM1; the disease is cold agglutinin disease.