Immunovant (NASDAQ:IMVT) announced topline results from two Phase 3 clinical studies evaluating batoclimab in patients with active, moderate-to-severe thyroid eye disease (TED) on Thursday, April 2, 2026.
In a significant setback for the program, both studies failed to meet their prespecified primary endpoint, defined as a proptosis responder rate of 2mm or greater at Week 24.
Despite the failure to reach statistical significance on the primary efficacy goal, the company noted that the safety profile of batoclimab remained consistent with previous findings, with no new safety signals identified across the trial populations.
Analysis of the data revealed a dose-dependent response; patients exhibited greater improvement in proptosis during the initial 12-week high-dose treatment period compared to the subsequent 12-week low-dose maintenance period.
Furthermore, a subset of patients with hyperthyroidism demonstrated thyroid hormone normalization rates that mirrored successful Phase 2 data previously seen in Graves’ disease.
While these secondary observations provided some clinical insight, they were insufficient to offset the primary endpoint miss.
Following the results, Immunovant stated it would review the future development path for batoclimab in coordination with its partner, HanAll Biopharma.
However, the company’s strategic focus appears to be shifting toward IMVT-1402, its next-generation FcRn inhibitor.
IMVT-1402 is currently being advanced in potentially registrational trials for several indications, including Graves’ disease, with topline data expected in 2027.