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# Immunovant Delays Seeking Approval of Batoclimab
- URL: https://www.fdaweb.com/immunovant-delays-seeking-approval-of-batoclimab/
- Published: 2025-03-20T12:00:00.000Z
- Updated: 2026-09-14T14:55:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158859

Despite Immunovant promising data from two batoclimab clinical studies for treating myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), the company says it is delaying its decision on whether to seek FDA approval until the results of ongoing Phase 3 studies in thyroid eye disease are available.

Batoclimab is described by the company as a monoclonal antibody that targets the FcRn receptor, which is involved in the recycling of immunoglobulin G (IgG) antibodies in the body, which provide protection against infections. The company’s next-generation anti-FcRn monoclonal antibody IMVT-1402, which may deliver more durable clinical responses for patients with autoimmune diseases, will soon begin Phase 3 studies in MG and CIDP patients. The company says it is focused on leveraging data and learnings from the batoclimab studies to inform and accelerate its programs with IMVT-1402.

Regarding batoclimab, Immunovant says a Phase 3 study met its primary endpoint, which was the mean change from baseline in a daily activities score in acetylcholine receptor antibody positive (AChR+) participants at Week 12 in MG patients. Additionally, a CIDP Phase 2 study showed that batoclimab-treated patients demonstrated a 1.8 point improvement in an inflammatory score, it says. Patients in the study are currently being assessed in Period 2 of treatment to determine the percentage of those who remain relapse-free at Week 36.