batoclimab (IMVT-1401) / Harbour BioMed, Roivant, Daewoong Pharma, CSPC Pharma, OmniAb - LARVOL DELTA

IMVT-1401-3202: Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease (clinicaltrialsregister.eu) - P2/3 | N=75 | Completed | Sponsor: Immunovant Sciences GmbH | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

Comparing Efficacy and Safety of Various Monoclonal Antibodies in Myasthenia Gravis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials (AAN 2026) - "Batoclimab (BAT) 680 mg significantly reduced the Quantitative MG (QMG) score compared to placebo (MD= -5.17; 95%CI:[-6.44, -3.89]; p <0.0001) and was rated the top performer (p-score = 0.96) for this endpoint...Eculizumab (ECU) was ranked best (p-score = 0.93) regarding the 15-item revised MG Quality of Life (MG-QoL 15r) score. Belimumab (BEL) 10 mg/kg was ranked best in terms of adverse events (p-score = 0.87)... ROZ 10 mg/kg ranked best for MG-ADL. BAT 680 mg significantly reduced QMG and ranked best. BAT 340 mg was best for MGC."

Retrospective data • Review • CNS Disorders • Immunology • Myasthenia Gravis

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Trial completion date: Apr 2025 ➔ Jan 2027

Trial completion date • CNS Disorders • Myasthenia Gravis

batoclimab (Businesswire) - "Immunovant anticipates sharing topline data from its two Phase 3 studies evaluating batoclimab as a treatment for active, moderate-to-severe thyroid eye disease in the first half of this year."

P3 data: top line • Thyroid Eye Disease

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Euthyroidism and Long-Term Remission of Graves' Hyperthyroidism Following Treatment With an FcRn Blocker: A Case Report. (PubMed, Thyroid) - "FcRn blockade may be an effective and potentially disease-modifying treatment for GD."

Journal • Endocrine Disorders • Grave’s Disease

Immunovant anticipates sharing topline data from both of its Phase 3 studies to evaluate batoclimab as a treatment for active moderate to severe thyroid eye disease (TED) in the first half of calendar year 2026. (The Manila Times) - "In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG."

Clinical data • Grave’s Disease • Myasthenia Gravis • Thyroid Eye Disease

A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease (clinicaltrials.gov) - P2 | N=35 | Completed | Sponsor: Immunovant Sciences GmbH | Active, not recruiting ➔ Completed

Trial completion • Endocrine Disorders • Grave’s Disease

HanAll Biopharma plans to launch eight new products this year and is set to announce clinical results for key new drug pipelines. (Chosun Biz) - "These include two phase 3 trials of batoclimab for thyroid eye disease (TED), topline registrational results for imeroprubart in difficult-to-treat rheumatoid arthritis (D2T RA), and early clinical results in cutaneous lupus erythematosus (CLE), which will be released sequentially. Phase 3 results for the dry eye disease treatment tanfanercept and whether the Parkinson's disease treatment HL192 enters clinical trials are also cited as key variables this year."

Clinical data • New trial • Cutaneous Lupus Erythematosus • Dry Eye Disease • Parkinson's Disease • Rheumatoid Arthritis

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Neonatal fc receptor antagonists in adult patients with primary immune thrombocytopenia: Systematic review and meta-analysis of randomized controlled trials (ASH 2025) - "Several FcRn inhibitors(namely efgartigimod, rozanolixizumab, and batoclimab) have shown promising results in clinical trials,but to date, no meta-analysis has synthesized randomized trial data to evaluate their efficacy and safetyin ITP.MethodsWe conducted a systematic review and meta-analysis of randomized, placebo-controlled trials evaluatingFcRn antagonists in adult patients with ITP. Despite the small number of short-duration trials and modest sample sizes, theconsistency of treatment effect and favorable safety profile support FcRn blockade as a promising andgenerally well-tolerated treatment option. Larger, longer-term studies are needed to confirm thedurability of response and better characterize the long-term safety profile."

Retrospective data • Review • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=114 | Completed | Sponsor: Immunovant Sciences GmbH | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

Immunovant... (GlobeNewswire) - "...expects to report results from the open-label portion of the potentially registrational trial of IMVT-1402 in D2T RA and topline results from the proof-of-concept trial of IMVT-1402 in CLE in calendar year 2026. In calendar year 2027, topline results are expected across three indications from the potentially registrational trials of IMVT-1402 in GD, MG and D2T RA. Immunovant continues to expect the first of the two batoclimab Phase 3 thyroid eye disease (TED) studies to read out before the end of calendar year 2025. However, due to evolving competitive dynamics, Immunovant anticipates sharing topline results from both TED studies concurrently in the first half of calendar year 2026."

Clinical data • Cutaneous Lupus Erythematosus • Grave’s Disease • Myasthenia Gravis • Rheumatoid Arthritis • Thyroid Eye Disease

THE ROLE OF FCRN ANTAGONISTS IN TRANSFORMING THE MYASTHENIA GRAVIS TREATMENT PARADIGM (WCN 2025) - "Early clinical trials of FcRn antagonists, such as efgartigimod, rozanolixizumab, and nipocalimab, have shown significant potential, including the reduction of symptom severity, rapid clinical improvement, and enhanced quality of life for patients with generalized myasthenia gravis (gMG). Furthermore, a Phase III clinical trial conducted in China for another FcRn antagonist, batoclimab, has also demonstrated positive results, further confirming the effectiveness and safety of this class of medications. The advent of FcRn antagonists marks a significant milestone in the management of MG, opening a new chapter of precision therapy in autoimmune neurology and offering a promising treatment paradigm for other IgG-mediated diseases."

CNS Disorders • Myasthenia Gravis

An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P2 | N=108 | Enrolling by invitation | Sponsor: Immunovant Sciences GmbH

New P2 trial • Pain

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Batoclimab Induces Very Rapid and Sustained Post-treatment Euthyroidism in Graves' Disease (ATA 2025) - "Batoclimab resulted in very rapid and sustained normalization of FT3/FT4. Six months after stopping treatment, 52% of patients remained euthyroid either off ATD or on ≤2.5 mg ATD/day."

Endocrine Disorders • Grave’s Disease

Immunovant Unveils Durability and Treatment-Free Six-month Remission Data with Potential to Change Treatment Paradigm for Uncontrolled Graves' Disease Patients (GlobeNewswire) - "At Week 48, or the end of the six-month follow-up period (patients off-treatment for 24 weeks), ~80% (17/21) patients maintained T3/T4 values ≤ upper limit of normal (ULN), indicating strong durability of response through six months off treatment; Of these 17 patients, ~50% (8/17) were in ATD free-remission and an incremental ~30% (5/17) were on ATD doses of 2.5 mg/day following six months off treatment, even with batoclimab’s suboptimal step-down dosing design during the treatment period."

P2 data • Grave’s Disease • Immunology

The FcRn Inhibitor Batoclimab Rapidly Normalizes Thyroid Function and Improves Clinical Outcomes in Graves' Disease (ENDO 2025) - "Batoclimab treatment rapidly normalized thyroid function and improved both cardiovascular and orbital manifestations of GD."

Clinical • Clinical data • Cardiovascular • Endocrine Disorders • Grave’s Disease • Mood Disorders • Psychiatry • Thyroid Eye Disease

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=100 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Major Upcoming Milestones (GlobeNewswire) - "Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of...2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of...2027. Topline results for the Phase 2 trial in CS are expected in the second half of...2026. Roivant and Priovant will be hosting an upcoming investor event on brepocitinib at 1:00 p.m. ET on Tuesday, June 17, 2025; Immunovant expects to report batoclimab six-month remission data from the proof-of-concept study in GD in the summer of 2025 and Phase 3 thyroid eye disease (TED) data in the second half of calendar year 2025. Immunovant plans to initiate a potentially registrational trial evaluating IMVT-1402 in SjD and a second potentially registrational trial in GD in the summer of 2025; Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of...2026"

Clinical data • New trial • Dermatomyositis • Grave’s Disease • Hypertension • Immunology • Sjogren's Syndrome • Thyroid Eye Disease • Uveitis

Comparative efficacy and acceptability of novel biologics in the treatment of myasthenia gravis: systematic review and network meta-analysis of randomized trials. (PubMed, Syst Rev) - "This study provides an updated, relative rank-order efficacy of novel biologics therapies for myasthenia gravis. These data may help inform the design and sample size calculation of future clinical trials and assist selection of combination therapy."

Journal • Retrospective data • Review • CNS Disorders • Immunology • Myasthenia Gravis

A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2024 ➔ Jul 2025

Enrollment closed • Trial primary completion date • Endocrine Disorders • Grave’s Disease

Efficacy and Safety of the FcRn Inhibitor, Batoclimab, in Graves' Thyroidal and Extrathyroidal Disease: a Proof-of-concept Study (ESPE-ESE 2025) - "Subcutaneous batoclimab very rapidly normalized FT3 and FT4 in most patients. By Week 12, more than half of patients had both T3 and T4 ≤ULN and were off ATD. Batoclimab also improved extrathyroidal signs."

Clinical • Endocrine Disorders • Grave’s Disease • Ophthalmology • Thyroid Eye Disease

Immunovant Announces Next Phase of Growth with Roivant Including Changes to its Leadership Team and Additional Indications Sjögren’s Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) for IMVT-1402 (GlobeNewswire) - "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...Immunovant has announced these changes in conjunction with a broader strategic transition as development activities begin to conclude for batoclimab and ramp up for IMVT-1402, with increased Roivant alignment and the announcement of two additional indications today....Roivant will host a live conference call and webcast at 8:00 a.m. EDT on Monday, April 21, 2025, to discuss these updates at Immunovant."

Pipeline update • Immunology • Systemic Lupus Erythematosus