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.
Select a button below to view the list of FDA events for that drug.
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:
- September 3, 2025
- Indication:
- Myasthenia Gravis
Announcement
Immunovant, Inc. today shared an abstract with six-month off-treatment data in uncontrolled Graves' disease (GD) patients treated with batoclimab for 24 weeks, to be presented at the 2025 Annual Meeting of the American Thyroid Association (ATA) on September 11, 2025.
AI Summary
Immunovant, Inc. shared an abstract showing six-month off-treatment results in uncontrolled Graves’ disease patients treated with batoclimab for 24 weeks. These data will be presented at the American Thyroid Association meeting on September 11, 2025.
The proof-of-concept study enrolled 25 patients, 21 of whom entered a 24-week off-treatment follow-up. At Week 48, about 80% (17/21) maintained normal T3 and T4 levels, indicating a durable response. Among these responders, roughly 50% (8/17) achieved remission without anti-thyroid drugs six months after ending batoclimab. Another 30% (5/17) remained on a low daily ATD dose (2.5 mg). Treatment included weekly subcutaneous injections of batoclimab (680 mg for 12 weeks, then 340 mg for 12 weeks).
Safety and tolerability matched prior batoclimab studies. These findings support FcRn blockade as a potential mechanism for disease modification. Two global registrational trials of IMVT-1402 are now enrolling, with topline data expected in 2027.
Read Announcement- 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.
Read Announcement
IMVT-1402 FDA Regulatory 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.
Read Announcement
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