Zenas BioPharma announced positive results from the Phase 3 INDIGO trial of obexelimab in IgG4-RD, showing a 56% reduction in the risk of flare compared to placebo. Obexelimab also met activity goals on secondary endpoints, with no new safety signals observed. Zenas plans to submit a Biologics License Application to the FDA in Q2 2026 and a Marketing Authorization Application to the EMA in H2 2026. The company anticipates obexelimab becoming a significant treatment option for autoimmune diseases. A conference call will be held on January 5, 2026, at 8:00 a.m. ET to discuss the trial results.

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