This section highlights FDA-related milestones and regulatory updates for drugs developed by Immunovant (IMVT).
Over the past two years, Immunovant has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Batoclimab and IMVT-1402. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Batoclimab - FDA Regulatory Timeline and Events
Batoclimab is a drug developed by Immunovant for the following indication: Myasthenia Gravis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Batoclimab
- Announced Date:
- March 19, 2025
- Indication:
- Myasthenia Gravis
Announcement
Immunovant, Inc reported topline results from its Phase 3 study of batoclimab in MG and initial results from Period 1 of its Phase 2b study in CIDP.
AI Summary
Immunovant, Inc. announced positive topline results from its Phase 3 study of batoclimab in myasthenia gravis (MG) and initial findings from Period 1 of its Phase 2b study in chronic inflammatory demyelinating polyneuropathy (CIDP). In the Phase 3 MG study, the primary endpoint was met, as AChR+ patients showed a notable improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. The higher dose (680 mg weekly) resulted in a 5.6-point improvement with a 74% mean IgG reduction, while the lower dose (340 mg weekly) achieved a 4.7-point improvement with a 64% mean IgG reduction.
In the Phase 2b CIDP study, Period 1 data demonstrated an average 1.8-point improvement in the adjusted INCAT disability score and an 84% responder rate among patients with over a 70% IgG reduction. These results suggest that deeper IgG lowering correlates with better clinical outcomes in both MG and CIDP.
Read Announcement- Drug:
- Batoclimab
- Announced Date:
- September 9, 2024
- Indication:
- Myasthenia Gravis
Announcement
Immunovant, Inc. today reported positive results from the Phase 2a trial of batoclimab in Graves' Disease. Immunovant also disclosed data from several proprietary market research studies that showed a consistent unmet need among ATD treated patients who are intolerant to, uncontrolled on or relapsed after ATDs.
AI Summary
Immunovant, Inc. announced positive Phase 2a trial results for batoclimab in the treatment of Graves’ Disease. In the study, patients with hyperthyroidism unresponsive to antithyroid drugs (ATDs) received high dose batoclimab (680 mg weekly) for 12 weeks. At the end of this period, 76% of patients showed improvement in their thyroid hormone levels without needing a higher ATD dose, and 56% were able to completely taper off ATDs. The data also revealed a strong link between IgG reduction and clinical outcomes.
In addition, Immunovant disclosed market research showing a consistent unmet need among patients who are intolerant to, uncontrolled on, or have relapsed after ATD therapy. This unmet need highlights a significant commercial opportunity for novel treatments in Graves’ Disease and supports further development of batoclimab, as well as upcoming trials for their IMVT-1402 candidate.
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IMVT-1402 - FDA Regulatory Timeline and Events
IMVT-1402 is a drug developed by Immunovant for the following indication: FcRn inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMVT-1402
- Announced Date:
- April 21, 2025
- Indication:
- FcRn inhibitor
Announcement
Immunovant, Inc announced next phase of growth including changes to its leadership team and the expanded development of IMVT-1402 into two new indications, SjD and CLE.
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