imeroprubart (IMVT-1402) / Roivant, Daewoong Pharma, Immunovant, HanAll Biopharma - LARVOL DELTA

Roivant…announced topline results from Period 1 of Immunovant’s proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE) (GlobeNewswire) - "The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE."

Discontinued • P2b data • Cutaneous Lupus Erythematosus

Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Sjogren's Syndrome

Major Upcoming Milestones (The Manila Times) - "Immunovant expects to report topline data from the proof-of-concept trial of IMVT-1402 in CLE and provide an update on the potentially registrational program of IMVT-1402 in D2T RA in the second half of calendar year 2026. In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG. In calendar year 2028, topline data are expected across potentially registrational trials of IMVT-1402 in CIDP and SjD."

P2 data • P3 data: top line • Cutaneous Lupus Erythematosus • Grave’s Disease • Immunology • Myasthenia Gravis • Rheumatoid Arthritis • Sjogren's Syndrome

New horizons for autoimmune hyperthyroidism with FcRn blockers. (PubMed, Curr Opin Endocrinol Diabetes Obes) - "FcRn blockade is a promising new therapeutic approach for the management of autoimmune hyperthyroidism. Durability, cost-effectiveness and patient selection remain to be defined."

Journal • Endocrine Disorders • Grave’s Disease • Immunology • Ophthalmology • Thyroid Eye Disease

Targeting FcRn for immunomodulation: a promising therapy in autoimmune inflammatory rheumatic diseases. (PubMed, Inflamm Res) - "FcRn blockade represents a promising precision-medicine strategy for IgG-driven AIIRD. Future studies should define optimal patient populations, identify predictive biomarkers, optimize next-generation molecules, and clarify long-term safety, pharmacoeconomic value, and opportunities for indication expansion."

Journal • Review • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Myositis • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome • Systemic Lupus Erythematosus

IMVT-1402-2505: A Long-Term Extension Study of IMVT-1402 in Adult Patients With Graves' Disease (clinicaltrialsregister.eu) - P1/2 | N=128 | Not yet recruiting | Sponsor: Immunovant Sciences GmbH | N=84 ➔ 128

Enrollment change • Endocrine Disorders • Grave’s Disease

Preliminary Results from IMVT-1402 Trial in D2T RA (The Manila Times) - "A total of 170 participants have been enrolled in the initial 16-week open label period (Period 1) of the study evaluating weekly subcutaneous (SC) dosing of IMVT-1402 600 mg...Baseline disease activity was high, with mean counts of 24.2 tender joints, 16.7 swollen joints, and a DAS28-CRP score of 6.1. At Week 16, the observed ACR20, ACR50, and ACR70 response rates were 72.7%, 54.5%, and 35.8%, respectively; participants who discontinued prior to Week 16 were imputed as non-responders. Among the subset of participants who had failed at least a JAK inhibitor and an anti-TNF inhibitor (N=107), the Week 16 observed ACR20, ACR50 and ACR70 response rates were 72.0%, 53.3% and 37.4%, respectively....We anticipate providing further updates on this program in the second half of calendar year 2026."

P2 data • Trial status • Rheumatoid Arthritis

IMVT-1402 proof-of-concept trial in cutaneous lupus erythematosus (CLE) is fully enrolled, with topline data expected in the second half of calendar year 2026; all other clinical development timelines remain on track (The Manila Times) - "In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG."

Enrollment closed • P2 data • Cutaneous Lupus Erythematosus • Grave’s Disease • Sjogren's Syndrome

A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) (clinicaltrials.gov) - P2 | N=56 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2027 ➔ Oct 2026

Enrollment closed • Trial primary completion date • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

IMVT-1402-2505: A Long-Term Extension Study of IMVT-1402 in Adult Patients With Graves' Disease (clinicaltrialsregister.eu) - P1/2 | N=33 | Not yet recruiting | Sponsor: Immunovant Sciences GmbH

New P1/2 trial • Endocrine Disorders • Grave’s Disease

Business and partner highlights from the first quarter of 2026 and recent weeks included the following: (Businesswire) - "The potentially registrational trial with IMVT-1402 in difficult-to-treat rheumatoid arthritis is fully enrolled, with topline data expected in the second half of this year. Topline data from the proof-of-concept trial with IMVT-1402 in cutaneous lupus erythematosus is also expected in the second half of this year; Potentially registrational studies with IMVT-1402 in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease remain on track with topline data in GD and MG expected in 2027."

P2 data • P3 data • Trial status • Cutaneous Lupus Erythematosus • Grave’s Disease • Myasthenia Gravis • Rheumatoid Arthritis • Sjogren's Syndrome

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease (clinicaltrials.gov) - P2 | N=158 | Recruiting | Sponsor: Immunovant Sciences GmbH | N=112 ➔ 158

Enrollment change • Trial initiation date • Endocrine Disorders • Grave’s Disease

A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) (clinicaltrials.gov) - P2 | N=56 | Recruiting | Sponsor: Immunovant Sciences GmbH

Trial initiation date • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Immunovant Sciences GmbH | Trial completion date: Jul 2028 ➔ Jul 2029

Trial completion date • Trial initiation date • Immunology • Sjogren's Syndrome

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: Immunovant Sciences GmbH

Trial initiation date • Endocrine Disorders • Grave’s Disease

IMVT-1402 (Businesswire) - "The potentially registrational trial with IMVT-1402 in difficult-to-treat rheumatoid arthritis is fully enrolled, with topline data expected in the second half of this year. Topline data from the proof-of-concept trial with IMVT-1402 in cutaneous lupus erythematosus is also expected in the second half of the year. Potentially registrational studies with IMVT-1402 in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease remain on track with topline data in each of GD and MG expected in 2027."

Clinical data • Cutaneous Lupus Erythematosus • Grave’s Disease • Myasthenia Gravis • Rheumatoid Arthritis • Sjogren's Syndrome

IMVT-1402-3101: Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis (clinicaltrialsregister.eu) - P2/3 | N=78 | Recruiting | Sponsor: Immunovant Sciences GmbH

New P2/3 trial • CNS Disorders • Myasthenia Gravis

IMVT-1402-2503: A Phase 2b Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Graves' Disease (clinicaltrialsregister.eu) - P1/2 | N=110 | Recruiting | Sponsor: Immunovant Sciences GmbH

New P1/2 trial • Endocrine Disorders • Grave’s Disease

IMVT-1402-2401: A Phase 2b Study of IMVT-1402 Treatment in CIDP (clinicaltrialsregister.eu) - P1/2 | N=79 | Recruiting | Sponsor: Immunovant Sciences GmbH

New P1/2 trial • Pain

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) (clinicaltrials.gov) - P2 | N=372 | Enrolling by invitation | Sponsor: Immunovant Sciences GmbH | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Endocrine Disorders • Grave’s Disease

Immunovant: Potentially registrational trial for IMVT-1402 in difficult-to-treat rheumatoid arthritis (D2T RA) fully enrolled, with topline data expected in the second half of calendar year 2026. (The Manila Times)

Enrollment closed • P2b data • Rheumatoid Arthritis

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

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) (clinicaltrials.gov) - P2 | N=372 | Not yet recruiting | Sponsor: Immunovant Sciences GmbH

New P2 trial • Endocrine Disorders • Grave’s Disease

A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) topline data now expected in calendar year 2026 (GlobeNewswire)

P2 data • Rheumatoid Arthritis