Immunovant, Inc. (IMVT), a clinical-stage immunology company, announced that both its Phase 3 studies of Batoclimab or IMVT-1401 in Thyroid eye disease or TED failed to meet their primary endpoints.
Following the news, IMVT is down 8.12% to $23.06 in the pre-market.
Company Profile
Immunovant develops monoclonal antibodies for the treatment of autoimmune diseases.
The firm develops IMVT-1402 for Graves' disease, rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, cutaneous lupus erythematosus, and Sjögren's disease, and Batoclimab or IMVT-1401 for myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and thyroid eye disease.
Phase 3 Trials dubbed as GO-1 and GO-2
The phase 3 trials dubbed G0-1 and GO-2 evaluated the efficacy of Batoclimab ,680 mg subcutaneous (SC) once a week (QW) for 12 weeks, followed by 340 mg SC QW for 12 weeks, versus placebo on proptosis responder rate at Week 24 for the treatment of Thyroid eye disease.
Key Findings
Based on the prespecified analysis plan, the studies failed to meet their primary endpoint of a proptosis responder rate of 2mm or more at Week 24, following 12 weeks of high-dose and 12 weeks of low-dose Batoclimab treatment.
Meanwhile, the firm noted that patients in the TED studies showed greater proptosis improvement from baseline after the initial 12-week high-dose period than after the subsequent 12-week low-dose period, supporting the benefit of deeper IgG suppression.
What's Ahead?
Immunovant intends to review future development plans for Batoclimab with its partner, HanAll Biopharma Co., Ltd. and to provide an update on the program.
Meanwhile, Immunovant also stated that it remains focused on advancing IMVT-1402 across multiple autoimmune diseases, with Graves' disease (GD) as a key strategic priority, and it expects the topline data for IMVT-1402 in Graves' disease in 2027. As of December 31, 2025, Immunovant's cash and cash equivalents totalled $994.5 million.
IMVT has traded between $12.72 and $29.25. The stock closed Wednesday's trade at $25.10, up 1.05%.
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