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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

- The INDIGO study met its primary and all key secondary endpoints with statistically significant results - - Obexelimab significantly lowered the total amount of glucocorticoid use and reduced glucocorticoid-related toxicities - - A Biologics License Application (BLA) for obexelimab in IgG4-RD was submitted to the FDA in May - WALTHAM, Mass., June 02, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceu

articleZenas Biopharma, Inc.June 2, 202613/news/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
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

About this update from Zenas Biopharma, Inc.

- The INDIGO study met its primary and all key secondary endpoints with statistically significant results - - Obexelimab significantly lowered the total amount of glucocorticoid use and reduced glucocorticoid-related toxicities - - A Biologics License Application (BLA) for obexelimab in IgG4-RD was submitted to the FDA in May - WALTHAM, Mass., June 02, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced the presentation of additional positive data from the Phase 3 INDIGO trial evaluating obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, held from June 3-6, 2026, in London, England and published online by the New England Journal of Medicine. Collectively, the results consistently demonstrated reductions in disease activity including flare burden as well as glucocorticoid use and toxicity across multiple endpoints. The safety profile of obexelimab was comparable to placebo. “The findings from the Phase 3 INDIGO trial for obexelimab in IgG4-RD mark a significant milestone for both the rheumatology community and patients living with this devastating disease,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “These results further validate the significant clinical activity of obexelimab and its favorable safety and tolerability profile. Combined with its unique inhibitory mechanism of action, potential for steroid sparing and convenient at-home subcutaneous self-administration, we believe obexelimab has the opportunity to become an important first-line therapy for the long-term management of IgG4-RD. We are excited about the possibility of making this important therapy available to patients.” “Physicians currently have very few treatment options for patients living with this chronic, progressive and debilitating disease,” said Emanuel Della Torre, M.D., Ph.D., Associate Professor of Medicine at Vita-Salute San Raffaele University in Milan, Italy. “The Phase 3 INDIGO data indicate obexelimab could offer a novel, highly active, self-administered therapy for people living with IgG4-RD, one th...

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