obexelimab (ZB012) / Xencor, Zenas BioPharma, BMS, Royalty - LARVOL DELTA

Clinically Meaningful Influenza and SARS-CoV-2 Vaccine Responses Following Treatment-Free Window of Obexelimab in patients with IgG4-RD (ACR Convergence 2026) - No abstract available

Clinical • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Obexelimab Reduced Glucocorticoid-Associated Toxicity in Patients With IgG4-Related Disease: Results From the Phase 3 Randomized, Placebo-Controlled Indigo Trial (ACR Convergence 2026) - "GCs for the treatment of immune mediated diseases can result in substantial toxicity. In INDIGO, obexelimab significantly reduced cumulative GC toxicity, with benefits observed across most toxicity domains, and consistently less GC toxicity across multiple GTI thresholds. Moreover, these benefits with regard to GC toxicity were most pronounced at higher thresholds of toxicity."

Clinical • P3 data • Dyslipidemia • Infectious Disease • Inflammation • Metabolic Disorders • Myositis

Zenas BioPharma Announces Upcoming Presentations of Obexelimab Data in IgG4-Related Disease at the IgG4ward! 6th International Symposium on IgG4-Related Disease and ACR Convergence 2026 (The Manila Times) - "New data from the Phase 3 INDIGO open-label extension will include the longer-term flare protection and safety data of obexelimab in IgG4-RD...Additional analyses will assess glucocorticoid-associated toxicity and vaccine responses."

Clinical data • P3 data • Immunology • Inflammation

Zenas BioPharma to Host Obexelimab IgG4-RD Investor Event (The Manila Times) - "The event will provide an overview of Immunoglobulin G4-Related Disease (IgG4-RD), including current management strategies, and the unmet need of people living with this disease. Management will also provide an update on the Company’s prelaunch preparedness strategies and the potential commercial opportunity for obexelimab for IgG4-RD, if approved by the U.S. Food and Drug Administration (FDA)."

Clinical • Immunology • Inflammation

OBEXELIMAB, A B CELL INHIBITOR, IN IGG4-RELATED DISEASE, INCLUDING PATIENTS WITH PANCREATOBILIARY INVOLVEMENT: RESULTS FROM THE PHASE 3 INDIGO TRIAL (UEGW 2026) - No abstract available

Clinical • P3 data • Inflammation

IgG4-related disease - treatment with anti-CD20, anti-CD19 antibodies, and other new drugs. (PubMed, Klin Onkol) - "Anti-CD20 and anti-CD19 antibodies represent the treatment of choice for IgG4-RD. They achieve a high number of complete treatment responses; however, the treatment does not end there, as it is necessary to prevent disease relapses, which are common without maintenance therapy."

Journal • Review • Eosinophilia • Fibrosis • Immunology • Inflammation • Oncology • Renal Disease

SunStone: A Study of Obexelimab in Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=190 | Active, not recruiting | Sponsor: Zenas BioPharma (USA), LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Sep 2026

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

Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026 (The Manila Times)

P2 data • Systemic Lupus Erythematosus

Obexelimab, a CD19 and FcγRIIb inhibitor of B cell function (The Manila Times) - "In August, the U.S. Food and Drug Administration (FDA) accepted the Company’s Biologics License Application (BLA) for obexelimab for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD): The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027. Zenas expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026."

EMA filing • FDA filing • PDUFA • Immunology • Inflammation

In August, our partner Bristol Myers Squibb announced they submitted a marketing authorization application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for obexelimab for the treatment of IgG4-RD (The Manila Times) - "The application is based on the results of the global Phase 3 INDIGO trial."

Japan filing • Immunology • Inflammation

IgG4-Related Kidney Disease and IgG4-Related Retroperitoneal Fibrosis: An Update on Diagnosis and Treatment. (PubMed, Kidney Int Rep) - "Corticosteroids are the traditional first line therapy; however, B cell-targeted therapies, including rituximab, inebilizumab, and obexelimab are more potent and less toxic than steroids. Early recognition and treatment are critical to prevent irreversible organ damage. This review summarizes the current understanding of the pathogenesis, clinical spectrum, diagnostic approach, and management strategies for IgG4-RD, IgG4-RKD, and IgG4-RPF."

Journal • Review • Fibrosis • Glomerulonephritis • Hematological Malignancies • Immunology • Infectious Disease • Lupus Nephritis • Lymphoma • Nephrology • Oncology • Rare Diseases • Renal Disease • Sjogren's Syndrome

Obexelimab reduces the risk of IgG4-RD flare. (PubMed, Nat Rev Rheumatol) - No abstract available

Journal • Inflammation

Obexelimab, a B Cell Inhibitor, in IgG4-Related Disease: Results From the Phase 3 INDIGO Trial (EULAR 2026) - P3 | "Adults with active IgG4-RD meeting 2019 ACR/EULAR classification criteria (score ≥20) initiated a standardized GC regimen (20–60 mg/day prednisone equivalent) to induce remission, followed by an 8-week taper to discontinuation. There were no deaths in the obexelimab group and one death (1.0%) in the placebo group. Conclusions The INDIGO trial, the largest randomized, double-blind, placebo-controlled study conducted in IgG4-RD, demonstrates the efficacy and safety of B cell inhibition with obexelimab in IgG4-RD, with significant reduction in IgG4-RD flares and improved complete remission while reducing the need for GC therapy compared to placebo."

P3 data • Infectious Disease • Inflammation

Obexelimab for the Treatment of IgG4-Related Disease. (PubMed, N Engl J Med) - P3 | "Among patients with active IgG4-related disease, weekly obexelimab treatment led to a significantly lower risk of disease flare and significantly less glucocorticoid exposure than placebo. (Funded by Zenas BioPharma; INDIGO ClinicalTrials.gov number, NCT05662241.)."

Journal • Immunology • Inflammation • Musculoskeletal Pain

Obexelimab and the Promise of Nondepleting B-Cell Therapy in IgG4-Related Disease. (PubMed, N Engl J Med) - No abstract available

Journal • Inflammation

Zenas BioPharma Announces Data from the Registrational Phase 3 INDIGO Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD), Simultaneously Presented at the EULAR 2026 Congress and Published in the New England Journal of Medicine (GlobeNewswire) - "Obexelimab demonstrated a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (HR 0.44; 95% CI 0.277–0.711; p=0.0005) during the 52-week randomized controlled period. A majority of patients treated with obexelimab (73.2%) remained flare-free through Week 52, compared to fewer than half (45.4%) of placebo-treated patients....The annualized adjudicated flare rate was 52% lower for obexelimab compared to placebo (HR 0.48; 95% CI 0.32-0.74; p=0.0008); 36 flares were observed in the obexelimab group compared with 72 in the placebo group. At Week 52, 37.1% of patients receiving obexelimab achieved complete remission compared to 19.6% of patients who received placebo, representing a 17.7% improvement (p=0.0049)."

P3 data • Immunology • Inflammation

Management of IgG4-Related Disease. (PubMed, Curr Rheumatol Rep) - "Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), such as mycophenolate mofetil, leflunomide, azathioprine, and methotrexate, are frequently used as steroid-sparing agents, although comparative evidence remains limited...Rituximab has demonstrated high efficacy as first-line therapy and in refractory or relapsing disease, and is widely used despite remaining off-label in most regions. More recently, the anti-CD19 monoclonal antibody inebilizumab became the first therapy approved for IgG4-RD following the MITIGATE trial, which showed reduced disease flares and increased rates of glucocorticoid-free remission. Additional emerging therapies include obinutuzumab, obexelimab, CAR-T cell therapy, and cytokine-targeted agents such as dupilumab and tocilizumab, although evidence for most remains limited. Management of IgG4-RD requires an individualized approach based on disease severity, organ involvement, relapse risk, patient's comorbidities and..."

Journal • Review • Inflammation

Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RD (GlobeNewswire) - "The BLA submission is supported by the results of the Phase 3 INDIGO registrational trial of obexelimab for the treatment of IgG4-RD...Data from the INDIGO trial will be presented during an oral session at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London, UK, on June 4, 2026."

FDA filing • P3 data • Immunology • Inflammation

Zenas BioPharma Announces Upcoming Presentation of Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) at EULAR 2026 Congress (The Manila Times) - "INDIGO, the largest randomized, double-blind, placebo-controlled study conducted in IgG4-RD, met the primary endpoint demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (HR 0.443; 95% CI 0.277-0.711; p=0.0005) during the 52-week randomized placebo-controlled period. Obexelimab also met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints: time to first investigator-determined flare requiring rescue therapy (p=0.0001), number of investigator- and AC-determined flares requiring rescue therapy (p=0.0008), proportion of patients achieving complete remission (p=0.0049), and cumulative glucocorticoid rescue therapy use (p=0.0042)."

P3 data • Immunology

Obexelimab, a CD-19 and FcgRIIb inhibitor of B cell function (GlobeNewswire) - "Zenas expects to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) this quarter and a Marketing Authorization Application (MAA) to the EMA in the second half of 2026...Completed enrollment in the Phase 2 SunStone trial, a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of obexelimab in patients with SLE. Zenas anticipates reporting topline overall and biomarker population results in the fourth quarter of 2026."

EMA filing • Enrollment closed • FDA filing • P2 data • Immunology • Systemic Lupus Erythematosus

ZB012-02-001: A Phase 2 Study of Obexelimab in Patients with Systemic Lupus Erythematosus (clinicaltrialsregister.eu) - P1/2 | N=91 | Active, not recruiting | Sponsor: Zenas Biopharma (USA) LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Efficacy and Safety of Obexelimab to Treat IgG4-Related Disease: Protocol for a Global, Randomized, Placebo-Controlled Trial. (PubMed, Rheumatol Ther) - P3 | "The INDIGO trial achieved its global enrollment goal with 194 patients, making it the largest phase 3 trial in IgG4-RD to date and providing 90% power to detect a clinically meaningful reduction in flare risk. This trial will provide critical evidence on B-cell inhibition as a treatment strategy for IgG4-RD and assess obexelimab as a potential steroid-sparing option to address significant unmet needs of this patient population."

Clinical • Journal • Inflammation

Zenas BioPharma Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Zenas expects to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026 and a Marketing Authorization Application (MAA) to the EMA in the second half of 2026. The Company expects that full data from the INDIGO trial will be presented at a future medical meeting...Topline results of the Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) expected 4Q 2026."

EMA filing • FDA filing • P2 data • P3 data • Immunology • Inflammation • Systemic Lupus Erythematosus

Week 12 Results from MoonStone, a Phase 2 Study of Obexelimab in Relapsing Multiple Sclerosis (ACTRIMS Forum 2026) - P2 | "At week 12, treatment with obexelimab resulted in a near complete suppression of the cumulative number of new GdE T1 lesions over weeks 8 and 12 compared with placebo, accompanied by reductions in new and/or enlarging T2-weighted lesions. No new safety concerns were observed during this study. These results provide the first clinical evidence of activity for obexelimab in RMS and support further investigation of this molecule as a novel B-cell inhibitor for the treatment of MS."

Late-breaking abstract • P2 data • CNS Disorders • Infectious Disease • Multiple Sclerosis

A randomized Phase 2 trial for Systemic Lupus Erythematosus is ongoing and Zenas expects to report topline results, including biomarker data from this trial in the fourth quarter of 2026. (GlobeNewswire)

Biomarker • P2 data • Systemic Lupus Erythematosus