Zenas Biopharma outlines obexelimab regulatory filings, pipeline milestones in corporate presentation
ZBIO•European filing and pipeline milestones
European regulatory filing for IgG4-RD is planned in 2H 2026 via an MAA submission to the EMA.
Pipeline priorities include Phase 3 orelabrutinib studies in progressive MS, with additional clinical readouts expected in late 2026.
Obexelimab regulatory filing and Phase 3 data
Zenas Biopharma highlighted FDA acceptance of its BLA for obexelimab in IgG4-related disease, with a PDUFA date of May 27, 2027.
Phase 3 INDIGO met its primary endpoint, cutting flare risk 56% versus placebo; 73% of treated patients were flare-free.
Key secondary endpoints favored obexelimab, including higher complete remission at week 52: 37.1% versus 19.6% on placebo.
