Zenas BioPharma reports positive Phase 3 INDIGO trial of obexelimab in IgG4-RD; plans BLA in Q2 2026

Zenas BioPharma, Inc.

Obexelimab met primary endpoint: 56% reduction in IgG4-RD flare risk vs placebo (HR 0.443, p=0.0005).
All four key secondary endpoints met with high statistical significance (p≤0.0049).
Safety profile favorable: SAEs 10% obexelimab vs 19% placebo; fewer infections.
Preliminary cash $360.5M as of Dec 31, 2025; expected to fund operations through end of 2026.
BLA submission to FDA planned Q2 2026; MAA to EMA H2 2026.

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