Zenas Biopharma posts corporate presentation on autoimmune disease pipeline, led by obexelimab

Zenas BioPharma, Inc.

Zenas BioPharma, Inc.

ZBIO

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  • Zenas Biopharma outlined plans for global marketing submissions for obexelimab in IgG4-related disease, with FDA BLA filing targeted for Q2 2026 and EMA MAA filing targeted for H2 2026.
  • Phase 3 INDIGO trial in IgG4-RD met primary endpoint, cutting flare risk 56% versus placebo (HR 0.443; p=0.0005); 73% of treated patients remained flare-free through week 52.
  • Safety profile in INDIGO showed serious adverse events at 10% versus 19% for placebo; grade 3 infections ran 2% versus 4%.
  • Multiple sclerosis program orelabrutinib advanced with Phase 3 trials initiated in PPMS in Q3 2025 and naSPMS in Q1 2026.
  • Pipeline updates included Phase 2 SLE topline data for obexelimab expected in Q4 2026; early-stage assets ZB021, ZB022, ZB014 guided to initial clinical readouts from late 2026 into 2027.


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