Immunovant's Batoclimab Fails Phase 3 TED

Immunovant, a clinical-stage immunology company, announced that its two Phase 3 clinical studies evaluating batoclimab as a treatment for active, moderate-to-severe thyroid eye disease (TED) failed to meet their primary endpoint. The studies aimed to achieve a >=2mm proptosis responder rate at Week 24 but did not succeed. Safety results were consistent with previous findings, with no new safety signals identified. Patients showed greater improvement during the high-dose period, suggesting a benefit from deeper IgG suppression. Immunovant plans to review the future development of batoclimab with its partner HanAll Biopharma Co., Ltd. Despite this setback, Immunovant remains focused on advancing IMVT-1402, another investigational FcRn blocker, for multiple autoimmune diseases, particularly Graves' disease, with topline data expected in 2027.