Zenas Biopharma Reports Positive Phase 3 Results for Obexelimab in IgG4-Related Disease

Reuters01-05

Zenas Biopharma Reports Positive Phase 3 Results for Obexelimab in IgG4-Related Disease

Zenas Biopharma Inc. announced positive results from the Phase 3 INDIGO registrational trial of obexelimab in patients with Immunoglobulin G4-Related Disease (IgG4-RD). The study met its primary endpoint, demonstrating a 56% reduction in the risk of IgG4-RD flare, and achieved statistically significant results across all four key secondary efficacy endpoints. Obexelimab was reported to be well tolerated with no new safety signals observed. Zenas plans 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 European Medicines Agency $(EMA)$ in the second half of 2026. The results were presented during a conference call and webcast on January 5, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zenas Biopharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9619554-en) on January 05, 2026, and is solely responsible for the information contained therein.

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The study met its primary endpoint, demonstrating a 56% reduction in the risk of IgG4-RD flare, and achieved statistically significant results across all four key secondary efficacy endpoints. Obexelimab was reported to be well tolerated with no new safety signals observed. Zenas plans 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 European Medicines Agency $(EMA)$ in the second half of 2026. The results were presented during a conference call and webcast on January 5, 2026.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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