Immunovant has ended batoclimab development after Phase 3 thyroid eye disease failures, shifting focus to next‑generation FcRn inhibitor IMVT‑1402, which is showing promising early rheumatoid arthritis data and advancing toward registrational programs in multiple autoimmune diseases.
By: Regulatory Desk
Immunovant, Inc. has discontinued development of batoclimab after two Phase 3 studies NCT05524571 and NCT05517421 in thyroid eye disease (TED) failed to meet their primary endpoints. The company announced the decision during its fourth quarter and fiscal year 2026 update on May 20, redirecting resources toward its next‑generation FcRn inhibitor, IMVT‑1402. Safety findings in the TED trials were consistent with prior batoclimab experience, with no unexpected signals reported.
Leveraging Clinical Infrastructure
Despite halting batoclimab, Immunovant emphasized that the clinical expertise, operational infrastructure, and investigator relationships established during the program will support ongoing development of IMVT‑1402 across multiple autoimmune indications.
Encouraging Early RA Data
Preliminary Week 16 results from an ongoing study NCT06754462 in difficult‑to‑treat rheumatoid arthritis (D2T RA) highlighted IMVT‑1402’s potential. In the open‑label portion, the therapy achieved observed ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8%, respectively. The study enrolled 170 patients, with 165 evaluable for analysis, most of whom represented a heavily pretreated population 86.7% had failed at least two advanced mechanisms, and the mean disease duration was 12.8 years.
Among patients who had failed both JAK inhibitors and anti‑TNF therapies, IMVT‑1402 produced similar outcomes, with ACR20, ACR50, and ACR70 response rates of 72.0%, 53.3%, and 37.4%. The drug was generally safe and well tolerated, with no new treatment‑related safety signals identified.
Pipeline Expansion
Immunovant expects additional updates from the D2T RA program and topline proof‑of‑concept data in cutaneous lupus erythematosus (CLE) during the second half of 2026. Potentially registrational programs for IMVT‑1402 remain on track in Graves’ disease, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren’s disease.
Financial Outlook
The company reported that its current cash position is expected to support operations through the potential launch of IMVT‑1402 in Graves’ disease, underscoring confidence in the asset’s trajectory.
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