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

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

Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=231 | Recruiting | Sponsor: Immunovant Sciences GmbH | Trial completion date: Dec 2027 ➔ Dec 2028

Trial completion date • CNS Disorders • Myasthenia Gravis

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

IMVT-1402 Registrational Trial Design (GlobeNewswire) - "Two potentially registrational trials of Immunovant’s lead compound IMVT-1402 in Graves’ disease will evaluate 600 mg dose for up to 52 weeks without a step-down in dose; The two potentially registrational global trials for IMVT-1402 in Graves’ disease are currently enrolling with topline readouts expected in 2027."

New trial • Grave’s Disease • Immunology

Major Upcoming Milestones (GlobeNewswire) - "Immunovant expects to report results from the open-label portion of the potentially registrational trial of IMVT-1402 in D2T RA and top-line results from the proof-of-concept trial of IMVT-1402 in CLE. In calendar year 2027, top-line results are expected across three indications from the potentially registrational trials of IMVT-1402 in D2T RA, GD and MG."

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

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Grave’s Disease

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Sjogren's Syndrome

SI02-22. Unmet Needs in Graves' Disease: Evolving Treatment Patterns and Future Management Strategies (ENDO 2025) - P2 | "Dr. Kahaly will review the design of a global Phase 2b pivotal clinical trial investigating the FcRn inhibitor IMVT-1402, which is actively enrolling adult patients with Graves' disease who remain hyperthyroid despite current therapy (ClinicalTrials.gov identifier: NCT06727604)."

Endocrine Disorders • Grave’s Disease • Immunology

HanAll Biopharma posts 28.8% sales growth in Q2, with new drug R&D results also visible. [Google translation] (Pharm News) - "The follow-up pipeline, HL161ANS (Immunovant codename IMVT-1402), is undergoing parallel clinical trials for six autoimmune diseases, including MG, glutathione dehydroepiandrosterone (GD), refractory rheumatoid arthritis (D2T RA), Sjögren's syndrome (SjD), and cutaneous lupus erythematosus (CLE). Key clinical results are expected to be announced between 2026 and 2028."

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

IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P2 | N=162 | Recruiting | Sponsor: Immunovant Sciences GmbH

New P2 trial • Pain

Study to Access the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=231 | Recruiting | Sponsor: Immunovant Sciences GmbH

New P3 trial • CNS Disorders • Myasthenia Gravis

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 | Not yet recruiting | Sponsor: Immunovant Sciences GmbH

New P2 trial • Endocrine Disorders • Grave’s 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

OmniAb Reports First Quarter 2025 Financial Results and Business Highlights (Businesswire) - "IMVT-1402...A fifth potentially registrational trial for Sjogren’s disease is planned to begin in the summer of 2025....The Company also expects that multiple partners will be presenting data from programs developed with OmniAb technology at the American Society of Clinical Oncology Annual Meeting taking place May 30 - June 3, 2025."

Clinical • New trial • Immunology

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 | Not yet recruiting | Sponsor: Immunovant Sciences GmbH

New P2 trial • Immunology • 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 | Recruiting | Sponsor: Immunovant Sciences GmbH

New P2 trial • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus

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

OmniAb Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights (Businesswire) - "Fourth quarter 2024 and recent partner highlights include the following: IMVT-1402:...IMVT-1402, is rapidly progressing with six Investigational New Drug (IND) applications now cleared and pivotal Phase 2b studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis now enrolling. Immunovant is on track to initiate potentially registrational programs for three additional indications for IMVT-1402 by March 31, 2025. In addition, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of 10 indications by March 31, 2026."

Enrollment status • New trial • Grave’s Disease • Rheumatoid Arthritis

Immunovant Reports Financial Results for the Quarter Ended December 31, 2024 (GlobeNewswire) - "Additional results from batoclimab proof-of-concept study in GD, including 6-month treatment free remission data expected in summer 2025; Top line results of the batoclimab trial in myasthenia gravis (MG) and initial results from period 1 of batoclimab trial in chronic inflammatory demyelinating polyneuropathy (CIDP) expected by March 31, 2025...As previously announced, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026...Top-line results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves' ophthalmopathy, continue to be expected in the second half of calendar year 2025..."

New trial • P2 data • P2b data • P3 data: top line • Grave’s Disease • Immunology • Myasthenia Gravis • Thyroid Eye 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 | Recruiting | Sponsor: Immunovant Sciences GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Immunovant Announces $450 Million Private Placement (GlobeNewswire) - “The additional capital will help us advance a broad development program for our lead asset IMVT-1402.”

Commercial • Immunology