mezagitamab (TAK-079) / Takeda, BioInvent, Ligand - LARVOL DELTA

Efficacy and Safety of Anti-CD38 Monoclonal Antibodies in Adults With Immune Thrombocytopenia: A Systematic Review and Single-Arm Meta-Analysis (SOHO 2026) - "Interventions: Daratumumab, mezagitamab, CM313, and other anti-CD38 monoclonal antibodies. Anti-CD38 monoclonal antibodies demonstrated promising efficacy with manageable toxicity in adults with relapsed or refractory immune thrombocytopenia. These findings support further prospective studies to define optimal administration strategies and long-term durability of responses."

Retrospective data • Review • Oncology

A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

TAK-079-3001: A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition (clinicaltrials.gov) - P3 | N=347 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=171 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition (clinicaltrials.gov) - P3 | N=347 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

TAK-079-3002: A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=171 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

TAK-079-3002: A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=171 | Recruiting | Sponsor: Takeda | N=101 ➔ 171

Enrollment change • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

TAK-079-3003: A Continuation Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Takeda | N=105 ➔ 150

Enrollment change • Trial initiation date • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

TAK-079-3003: A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Takeda | N=107 ➔ 150

Enrollment change • Trial initiation date • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Ligand Completes Acquisition of XOMA Royalty, Creating a Portfolio of More than 200 Biopharmaceutical Royalty Assets (The Manila Times) - Acquisition adds seven commercial products including VABYSMO (faricimab-svoa), OJEMDA (tovorafenib), and MIPLYFFA (arimoclomol), andmore than 100 development and commercial-stage assets, creating long-term opportunities to drive growth...Additionally, it includes 14 late-stage development programs, featuring Takeda’s mezagitamab and certain assets from Takeda’s externalized asset portfolio, such as osavampator, volixibat, and OHB-607, along with more than 100 assets in various stages of development....Ligand will provide an updated 5-year outlook during the Company’s Investor Day on December 8, 2026."

M&A • Bronchopulmonary Dysplasia • Diabetic Macular Edema • Diabetic Retinopathy • IgA Nephropathy • Immune Thrombocytopenic Purpura • Immunology • Low Grade Glioma • Lysosomal Storage Diseases • Metabolic Dysfunction-Associated Steatohepatitis • Primary Biliary Cholangitis • Wet Age-related Macular Degeneration

Early and sustained improvement in health-related quality of life with mezagitamab in chronic/persistent immune thrombocytopenia: Results from a phase 2, randomized, controlled study (ISTH 2026) - P2 | "Conclusions Participants with chronic/persistent ITP who received mezagitamab had early and clinically meaningful improvements on multiple ITP-PAQ scales, with sustained effects off treatment. DOI*10.1016/j.rpth.2026.103587"

Clinical • HEOR • P2 data • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Takeda

New P2 trial • Antibody-mediated Rejection • Transplantation

TAK-079-1002: A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology • Transplantation

A Phase 2 Randomized Trial of Mezagitamab in Primary Immune Thrombocytopenia. (PubMed, N Engl J Med) - P2 | "Treatment with mezagitamab led to increased platelet counts, with a safety profile that appeared to be similar to that of placebo among participants with persistent or chronic ITP. (Funded by Takeda Development Center Americas; ClinicalTrials.gov number, NCT04278924.)."

Clinical • Journal • P2 data • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Evolving understandings for the roles of CD38 protein in autoimmunity and autoimmune disease. (PubMed, Clin Exp Immunol) - "CD38-targeted monoclonal antibodies with favorable therapeutic effects have been discovered, such as isatuximab, daratumumab, and mezagitamab. CD38 protein is a promising biomarker of autoimmune diseases diagnosis and a potential therapeutic target for the treatment of autoimmune diseases. In this review, we will focus on the latest findings on the involvement of CD38 in autoimmunity and autoimmune disease, and assess the value of research and application of CD38 in disease control."

IO biomarker • Journal • Hematological Malignancies • Immunology • Inflammation • Multiple Myeloma • Oncology

TAK-079-3001: A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition (clinicaltrialsregister.eu) - P2/3 | N=83 | Recruiting | Sponsor: Takeda Development Center Americas Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

TAK-079-3003: A Follow-up Study of Mezagitamab in Adults with Chronic Primary Immune nThrombocytopenia (clinicaltrialsregister.eu) - P2/3 | N=83 | Recruiting | Sponsor: Takeda Development Center Americas Inc.

New P2/3 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

TAK-079-3002: A Study to Evaluate the Efficacy and Safety of Mezagitamab Subcutaneous Injection Compared With Placebo in Adults With Chronic Immune Thrombocytopenia (clinicaltrialsregister.eu) - P2/3 | N=77 | Recruiting | Sponsor: Takeda Development Center Americas Inc.

New P2/3 trial • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

TAK-079-3001: A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition (clinicaltrialsregister.eu) - P2/3 | N=83 | Not yet recruiting | Sponsor: Takeda Development Center Americas Inc.

New P2/3 trial • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Takeda’s Phase 3 Mezagitamab Trial in ITP Moves Forward, Keeping Pipeline Hopes in Focus (TipRanks) - "This is an interventional Phase 3 study with patients randomly assigned to either mezagitamab or placebo. It uses a parallel-group model, meaning each participant stays in their assigned group throughout the trial."

Trial status • Immune Thrombocytopenic Purpura

TAK-079-1006: A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Dec 2025 | Trial primary completion date: Mar 2026 ➔ Dec 2025

Trial completion • Trial completion date • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

XOMA Royalty and Takeda Execute Strategic Royalty Sharing Transaction and Amend Existing Agreement for Mezagitamab (XOMA Press Release) - "Takeda’s royalty and milestone payment obligations to XOMA Royalty related to mezagitamab will be reduced, and XOMA Royalty will receive payments based on low to mid-single-digit royalties and milestones across a basket of nine development-stage assets that are held within Takeda’s externalized assets portfolio....Prior to amending the collaboration, XOMA Royalty held a mid-single digit royalty and $16.25 million in potential milestones associated with mezagitamab. Going forward, XOMA Royalty will retain a low single-digit royalty entitlement on mezagitamab and up to $13.0 million in milestones."

Commercial • Hematological Malignancies

Trial in progress: Study design of a randomized, phase 3 trial evaluating the efficacy and safety of mezagitamab (TAK-079) compared with placebo in adults with chronic primary immune thrombocytopenia (ASH 2025) - P2, P3 | "Use of additional, stable Background ITPtherapy is permitted, including corticosteroids, thrombopoietin receptor agonists, and fostamatinib, as isuse of rescue therapy (corticosteroids, intravenous immunoglobulin, platelet transfusion) whenindicated. Given promising, early-stage results for anti-CD38 treatment in patients who have beendifficult to manage on current therapies, this global study will evaluate the efficacy and safety ofsubcutaneous mezagitamab as a potential novel therapy for patients with ITP who have had aninsufficient response or intolerance to prior therapy."

Clinical • P3 data • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Thrombocytopenia • Thrombocytopenic Purpura

Safety, Tolerability, and Efficacy of Mezagitamab (TAK-079) as Add-On to Standard-of-Care Therapy in Individuals with Primary IgAN: Week 96 Data from an Open-Label Phase 1b Study (KIDNEY WEEK 2025) - P1 | "Renal function (eGFR) remained stable through Week 96 (mean change from baseline 2.9; 95% CI: −1.8, 7.6; n=12). Conclusion Mezagitamab was generally well-tolerated as an add-on to standard-of-care therapy and led to rapid and sustained reductions in UPCR and stable eGFR through Week 96."

Clinical • P1 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease