Zenas BioPharma Announces Positive Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD)
- Obexelimab met the primary endpoint demonstrating a clinically meaningful and highly statistically significant 56% reduction in risk of IgG4-RD flare - - Obexelimab also met and demonstrated statistically significant activity on all four key secondary efficacy endpoints - - Obexelimab was well tolerated and no new safety signals were observed - - Zenas anticipates submitting a Biologics License Application (BLA) to the FDA in the second quarter of 2026 and a Marketing Authorization Application (MAA) to the EMA in the second half of 2026 - - Zenas to host a conference call today, January 5, 2026, at 8:00 a.m. ET - WALTHAM, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc