BioTech

Zenas: Phase 3 INDIGO Trial Of Obexelimab Meets Primary Endpoint

January 05, 2026 — 07:33 am EST

Written by RTTNews.com for RTTNews

(RTTNews) - Zenas BioPharma (ZBIO) reported positive results from the Phase 3 INDIGO trial of obexelimab in Immunoglobulin G4-Related Disease. Obexelimab met the primary endpoint, demonstrating 56% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period. Obexelimab also met and demonstrated statistically significant activity compared to placebo on all four key secondary endpoints. The company expects that full data from the INDIGO trial will be presented at a future medical meeting.

Zenas expects submitting the obexelimab BLA to the FDA for the treatment of IgG4-RD in the second quarter of 2026. Zenas also plans to submit a Marketing Authorization Application to the European Medicines Agency in the second half of 2026.

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