Immunovant, Inc.

Overview

Immunovant is a clinical-stage immunology company developing therapies for autoimmune diseases driven by pathogenic IgG antibodies. Its core program is IMVT-1402 (imeroprubart), a fully human monoclonal antibody that inhibits the neonatal Fc receptor (FcRn) to reduce IgG levels. IMVT-1402 is being developed across six indications: Graves’ disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), Sjögren’s disease (SjD), and cutaneous lupus erythematosus (CLE).

Batoclimab, an earlier anti-FcRn candidate, was pursued previously. In April 2026 two registrational Phase 3 studies in thyroid eye disease (TED) did not meet primary endpoints; Immunovant discontinued batoclimab development and redirected resources to IMVT-1402. Learnings from batoclimab are informing IMVT-1402 development.

Ownership and partnerships

Immunovant is a majority-owned subsidiary of Roivant Sciences Ltd. (RSL) and uses Roivant’s platform and resources for development, operations, partnerships, and talent networks. Immunovant holds a key license from HanAll Biopharma Co., Ltd. (the HanAll Agreement) that provides rights to batoclimab, IMVT-1402, and other antibodies outside the U.S. and EU, subject to royalties and milestone obligations.

Intellectual property and commercial terms

• HanAll Agreement grants Immunovant rights to develop, manufacture, and commercialize the licensed antibodies in the licensed territory; HanAll retains certain patent prosecution and defense rights while Immunovant controls prosecution in the Licensed Territory.
• Contingent payments to HanAll: up to $420.0 million upon achieving regulatory and sales milestones.
• Royalties: mid-single to mid-teens percentage of net sales, subject to offsets and reductions.
• The HanAll Agreement expires on a product-by-product basis when the royalty and payment obligations end.
• In 2026 Immunovant completed an internal reorganization that transferred intellectual property between two wholly owned subsidiaries while retaining ownership within the Immunovant group.

IMVT-1402 (imeroprubart): product and clinical status

• Mechanism: FcRn inhibition intended to increase IgG degradation by preventing IgG recycling.
• Phase 1 (New Zealand, 2023): 300 mg MAD cohort showed approximately 63% reduction in total IgG; 600 mg MAD cohort showed approximately 74% reduction. Albumin and LDL changes were minimal, and the treatment was generally well tolerated.
• Development goals: achieve potent IgG reductions with a favorable safety profile and convenient subcutaneous administration via the YpsoMate autoinjector for broad indications.
• Commercial formulation and device: all IMVT-1402 studies use the intended commercial formulation and the YpsoMate autoinjector.

Batoclimab

• Phase 3 TED results (April 2026): two registrational studies failed to meet primary endpoints; safety findings were consistent with prior batoclimab data.
• Decision: batoclimab development discontinued across all indications; resources reallocated to IMVT-1402.

Development pipeline and key milestones

• Graves’ Disease (GD)
  • NCT06727604 (Dec 2024): randomized, placebo-controlled, 52-week trial in adults remaining hyperthyroid on an antithyroid drug (ATD). 240 planned participants; three-arm design. Primary endpoint: proportion euthyroid and off ATD at week 26. Top-line results expected in 2027.
  • NCT07018323 (Jun 2025): randomized, placebo-controlled, 26-week trial; ~210 participants across three arms (600 mg weekly, 300 mg weekly, placebo). Primary endpoint: proportion euthyroid and off ATD at week 26. Top-line results expected in 2027.
• Rheumatoid Arthritis (D2T RA)
  • NCT06754462 (Dec 2024): fully enrolled. Open-label induction followed by randomized blinded period. Period 1 enrolled 170 participants; Period 2 randomizes to IMVT-1402 600 mg, 300 mg, or placebo. Baseline population is heavily pretreated and seropositive. Updates expected in 2026.
• Myasthenia Gravis (MG)
  • NCT07039916 (Mar 2025): Phase 3, randomized, placebo-controlled, 26 weeks with a 52-week extension. ~230 participants across three arms (600 mg weekly, 300 mg weekly, placebo). Primary endpoint: change in MG-ADL at week 12. Top-line results expected in 2027.
• CIDP
  • NCT07032662 (Mar 2025): Phase 3, randomized, placebo-controlled, 24 weeks with a 52-week open-label extension. ~162 participants (2:1) to IMVT-1402 600 mg weekly vs placebo. Primary endpoint: relapse-free status at week 24. Top-line results expected in 2028.
• Sjögren’s Disease (SjD)
  • NCT06979531 (Jun 2025): randomized, double-blind, placebo-controlled, parallel-group; ~180 participants (1:1:1) to 600 mg, 300 mg, or placebo weekly SC for two 24-week periods. Primary endpoint: ClinESSDAI at week 24. Top-line results expected in 2028.
• Cutaneous Lupus Erythematosus (CLE)
  • NCT06980805 (Feb 2025): Phase 2b randomized, double-blind, placebo-controlled. Period 1: 12 weeks (600 mg weekly vs placebo); Period 2: all receive IMVT-1402 for 14 weeks; Period 3: rerandomization to 300 mg or 600 mg for 26 weeks. Primary endpoint: percent change in CLASI-A at week 12. Top-line results expected in the second half of 2026.

Across indications, the program targets strong IgG reductions and uses a self-administered autoinjector to support convenient dosing.

Manufacturing and operations

Immunovant does not own manufacturing facilities and relies on third parties for clinical and potential commercial supply. Biologics manufacturing is complex and could present production or quality-control challenges that affect regulatory approval or commercialization.

Market context and unmet need

FcRn inhibition is being pursued to treat IgG-mediated autoimmune diseases with substantial unmet medical need, including GD, D2T RA, MG, CIDP, SjD, and CLE. The company positions IMVT-1402 to deliver deep IgG reductions that may translate into clinical benefit, informed by data from batoclimab and the broader FcRn inhibitor class.

Financial position and obligations

The company has stated it has a limited operating history and has never generated product revenue. Immunovant will require additional capital to fund operations and may incur losses for the foreseeable future. Milestone payments to HanAll and royalty obligations are material financial considerations for future commercialization.

Current status

• Batoclimab development discontinued.
• IMVT-1402 is advancing through multiple potentially registrational and proof-of-concept trials across six autoimmune indications, with key topline readouts expected between 2026 and 2028 depending on the program and trial timelines.