Zenas BioPharma highlights FDA review acceptance for obexelimab IgG4-RD filing in corporate presentation
ZBIO•Pipeline priorities and financing agreement
Pipeline priorities include orelabrutinib Phase 3 programs in progressive multiple sclerosis, with additional Phase 2 readouts for obexelimab in RMS and SLE.
Royalty Pharma agreement provides up to USD 300 million total investment, including USD 75 million upfront, tied to IgG4-RD and SLE milestones.
FDA review acceptance and Phase 3 results for obexelimab
Zenas BioPharma outlined plans to seek U.S. approval for obexelimab in IgG4-related disease, with an FDA decision expected by May 2027.
Phase 3 INDIGO met its primary endpoint, cutting flare risk 56% versus placebo; 73% of treated patients remained flare-free through week 52.
Complete remission at week 52 reached 37.1% on obexelimab versus 19.6% on placebo; cumulative rescue glucocorticoid dose fell 65%.
