atacicept (VT-001) / EMD Serono, Vera Therap - LARVOL DELTA

Reduced BCMA Signaling Disrupts the BAFF/APRIL Axis and Promotes Inflammatory Cytokine Production by B Cells in Multiple Sclerosis. (IMMUNOLOGY 2026) - "While anti-CD20 therapies reduce disease activity, atacicept, a BAFF/APRIL inhibitor, unexpectedly worsened MS... Together, these findings identify BCMA as a key mediator of BAFF/APRIL-driven regulatory B cell function in MS. Impaired BCMA signaling may disrupt the balance between inflammatory and regulatory B cells, linking altered B cell homeostasis to disease activity. These results highlight BCMA as a potential therapeutic target to restore immune balance without global B cell depletion."

IO biomarker • CNS Disorders • Immunology • Multiple Sclerosis • IL10 • IL6 • NEFL

ORIGIN EXTEND: A LONG-TERM EXTENSION STUDY OF ATACICEPT IN IGA NEPHROPATHY (ISN-WCN 2026) - "J. Barratt is employed by the University of Leicester; reports consultancy relationships with Alexion, Astellas, Alebund, Alnylam, Alpine, Argenx, BioCryst, Calliditas, Chinook, Dimerix, HiBio, Kira, Novartis, Omeros, Otsuka, Travere Therapeutics, Q32 Bio, Roche, Sanofi, Takeda, Vera Therapeutics, Inc., Vifor, Visterra; has received research funding from: Alexion, Novartis; GlaxoSmithKline; Calliditas, Visterra, Chinook, Omeros, Galapagos, Argenx, Travere Therapeutics; and serves on the editorial boards of Kidney International, CJASN, and Glomerular Diseases & Clinical Science, and as a Treasurer of the International IgA Nephropathy Network.I did not use generative AI and AI-assisted technologies in the writing process."

Glomerulonephritis • IgA Nephropathy • Renal Disease

PIONEER: A BASKET TRIAL OF ATACICEPT IN AUTOIMMUNE-MEDIATED GLOMERULAR DISEASE (ISN-WCN 2026) - "G. Chertow is employed by the Stanford University School of Medicine; reports consultancy relationships with Akebia, Alebund, Ardelyx, AstraZeneca, CalciMedica, Miromatrix, Panoramic, Sanifit, Toku, Unicycive, and Vertex; holds ownership interests in Ardelyx, CloudCath, Durect, Eliaz Therapeutics, Outset, Renibus, and Unicycive; has received research funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), and CSL Behring; serves in advisory or leadership roles on the Board of Directors of Satellite Healthcare and as Co-Editor of Brenner & Rector's The Kidney (Elsevier); and has other interests including service on data and safety monitoring boards for NIDDK, the George Institute, Aethlon, Bayer, Mineralys, and ReCor.I did not use generative AI and AI-assisted technologies in the writing process."

Pan tumor • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Focal Segmental Glomerulosclerosis • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease • Metabolic Disorders • Nephrology • Renal Disease

ORIGIN 3: A PHASE 3 TRIAL OF ATACICEPT IN IGA NEPHROPATHY (ISN-WCN 2026) - "R. Lafayette is employed by Stanford University; reports consultancy relationships with Calliditas, Chinook, Omeros, Otsuka, Alexion, Travere, Vera Therapeutics, Novartis, Aurinia, Visterra, Alpine Bio, and BeiGene; and has received research funding from the National Institutes of Health (NIH), Pfizer, Roche, Amgen, Otsuka, Omeros, Calliditas, Travere, Apellis, Chinook, Vera Therapeutics, and BeiGene.I did not use generative AI and AI-assisted technologies in the writing process."

P3 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Targeting BAFF and APRIL with Atacicept (ISN-WCN 2026) - "Organized by: Vera Therapeutics"

IgA Nephropathy • Renal Disease

Industry Symposium 36: Emerging Therapeutic Approaches in IgA Nephropathy: Innovations in B-Cell Modulation and Dual BAFF/APRIL Inhibition (ISN-WCN 2026) - "· Summarize the latest clinical evidence for dual BAFF/APRIL inhibition (e.g., atacicept) and other emerging therapies in IgAN. · Discuss practical considerations for integrating novel therapies into patient management and clinical practice guidelines."

Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

VT-001-0020: A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN (clinicaltrialsregister.eu) - P1/2 | N=27 | Active, not recruiting | Sponsor: Vera Therapeutics Inc. | Recruiting ➔ Active, not recruiting

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

Comparative Network Meta-Analysis (NMA) of Sibeprenlimab Efficacy in the Treatment of Immunoglobulin A Nephropathy (IgAN) (NKF-SCM 2026) - "Treatments analyzed were: sibeprenlimab, atacicept, atrasentan, sparsentan, cemdisiran, TRF-budesonide, ravulizumab, and iptacopan. CONCLUSION Sibeprenlimab demonstrates clinically significant reductions in uPCR compared with other treatments, suggesting potential in IgAN. Updated NMA will be conducted when full Phase 3 results for sibeprenlimab are available."

Retrospective data • Glomerulonephritis • IgA Nephropathy • Renal Disease

VT-001-0020: A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN (clinicaltrialsregister.eu) - P1/2 | N=27 | Recruiting | Sponsor: Vera Therapeutics Inc.

New P1/2 trial • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

VT-001-0060: Atacicept in Multiple Glomerular Diseases (clinicaltrialsregister.eu) - P1/2 | N=107 | Recruiting | Sponsor: Vera Therapeutics Inc.

New P1/2 trial • Immunology • Renal Disease

Natural History Model of Lifetime Burden of Immunoglobulin A Nephropathy (IgAN) in the United States (NKF-SCM 2026) - "CONCLUSION Using supportive therapy alone results in progressive decline of kidney function and high incremental costs. B-cell modulators such as atacicept may improve quality of life and reduce long-term burden associated with IgAN by preserving kidney function."

Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Immunology • Nephrology • Renal Disease

ORIGIN 3: A Phase 3 Trial of Atacicept in IgA Nephropathy (NKF-SCM 2026) - "CONCLUSION Atacicept treatment resulted in a statistically significant proteinuria reduction compared with placebo at Week 36, as well as Gd-IgA1 reduction, hematuria resolution, and a favorable safety profile. The results demonstrate the potential for atacicept to address the underlying pathophysiology of IgAN and provide a targeted, disease-modifying therapy."

P3 data • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

Reduced BCMA Signaling Disrupts the BAFF/APRIL Axis and Promotes Inflammatory Cytokine Production by B Cells in Multiple Sclerosis. (ACTRIMS Forum 2026) - "While anti-CD20 therapies reduce disease activity, atacicept, an inhibitor of BAFF and APRIL, unexpectedly worsened MS, revealing a paradox in B cell biology... Our findings identify a critical BCMA-dependent BAFF/APRIL signaling axis that maintains immune homeostasis by promoting regulatory B cell function and restraining inflammatory B cell activation. Reduced transitional B cells and impaired BCMA signaling in MS may drive pathogenic B cell responses and disease activity. Targeting this pathway could restore immune balance and provide a therapeutic strategy that preserves protective B cells while limiting inflammation."

IO biomarker • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • IL10 • IL6 • NEFL

Emerging Therapies in IgA Nephropathy: From A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) Inhibitors to Precision Medicine. (PubMed, Cureus) - "This review synthesizes current evidence on evolving treatments, with a focus on A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF) (e.g., sibeprenlimab, atacicept, povetacicept, telitacicept), complement pathway modulators (e.g., iptacopan, cemdisiran, ravulizumab), and novel agents such as felzartamab and sparsentan. It also explores precision medicine strategies, including biomarker-guided therapy, individualized risk stratification, and combination regimens. Supported by high-quality recent clinical trial data and the latest kidney disease outcome guidelines, these innovations represent a paradigm shift toward personalized, disease-modifying treatment in IgAN, offering a new horizon for improved renal outcomes and long-term disease control."

Journal • Review • Chronic Kidney Disease • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

A plain language summary: long-term safety and effectiveness of atacicept in individuals with IgA nephropathy. (PubMed, Curr Med Res Opin) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Renal Disease

Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy (GlobeNewswire) - "The BLA, which was submitted using the Accelerated Approval Program, was assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026....The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36."

FDA filing • PDUFA • Priority review • IgA Nephropathy

Efficacy and safety of BAFF/APRIL dual antagonists in IgA nephropathy: a systematic review and meta-analysis of randomized controlled trials. (PubMed, BMC Nephrol) - No abstract available

Journal • Retrospective data • Glomerulonephritis • IgA Nephropathy • Renal Disease

PIONEER: A Basket Trial of Atacicept in Autoimmune Mediated Glomerular Disease (KIDNEY WEEK 2025) - "Eligible pts will receive atacicept 150 mg via at-home once-weekly subcutaneous injection for up to 52 weeks. Key efficacy endpoints will include changes from baseline in UPCR, eGFR, and disease-specific antibody levels."

Pan tumor • Chronic Kidney Disease • Focal Segmental Glomerulosclerosis • Glomerulonephritis • IgA Nephropathy • Immunology • Nephrology • Renal Disease

Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy (GlobeNewswire) - "The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36....Potential FDA approval in 2026."

FDA approval • FDA filing • IgA Nephropathy

ORIGIN 3: A Phase 3 Trial of Atacicept in IgAN (KIDNEY WEEK 2025) - No abstract available

P3 data • Glomerulonephritis • IgA Nephropathy

Imbalanced Expression of TACI Isoforms Regulated By TNFRSF13B Variants Promotes the Progression of Epstein-Barr Virus-Associated Lymphoproliferative Diseases (ASH 2024) - "For patients who carry the gain-of-function germline mutations of TNFRSF13B, the inhibitory TACI-Ig or the TACI ligands BAFF and APRIL may efficiently prevent the serious progression of their EBV infection. Screening for possibly pathogenic variants, especially in the TNF-TNFR superfamily genes in EBV-LPD patients is necessary and valuable for understanding the pathogenesis of EBV-LPDs and optimizing the therapeutic regimen."

Epstein-Barr Virus Infections • Infectious Disease • TNFA • TNFRSF13B • TUSC3 • UNC13D

ORIGIN Extend: A Long-Term Extension Study of Atacicept in IgAN (KIDNEY WEEK 2025) - "ORIGIN Extend will provide pts continued access to atacicept, capture longer-term safety and efficacy data, and explore reinitiation of atacicept following an off-treatment period. 1 Barratt J. JASN 2024."

Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy. (PubMed, N Engl J Med) - P3 | "In this prespecified interim analysis, treatment with atacicept resulted in a significantly greater reduction in proteinuria than placebo at week 36 in patients with IgA nephropathy. (Funded by Vera Therapeutics; ORIGIN 3 ClinicalTrials.gov number, NCT04716231.)."

Journal • P3 data • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

The Use Of Preclinical Models To Understand Drivers Of Lupus Pathogenesis (ACR Convergence 2025) - "Overexpression of IFNα via hydrodynamic DNA delivery (HDD) was used to evaluate the role of IFNα in these strains, while TACI-Ig-mediated B cell depletion was performed to determine the contribution of B cells to pathogenesis. The respective contributions of IFNa and BAFF, representing pathways with approved targeted therapeutics in SLE, were evaluated and analyzed between these strains... Here we describe two models of SLE-like disease that respond differently to manipulation of key pathways targeted by existing approved therapeutics. Taken together, these data suggest that NZB/W and C9orf72-/- mice recapitulate distinct disease mechanisms relevant to human patients and can be used in preclinical efforts to validate therapeutic strategies for a heterogeneous SLE patient population."

Preclinical • Immunology • Inflammatory Arthritis • Lupus • Renal Disease • Systemic Lupus Erythematosus • IFNA1

Atacicept in Multiple Glomerular Diseases (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Vera Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Focal Segmental Glomerulosclerosis • Glomerulonephritis • IgA Nephropathy • Immunology • Nephrology • Renal Disease