oral, brain-penetrant, TYK2 inhibitor — IND submission
2026
Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026.Source filing
ZBIO biotech catalysts & pipeline
ZENAS BIOPHARMA INC · Data as of 2026-09-08
Upcoming catalysts
oral, IL-17AA/AF inhibitor — IND submission
2026
Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026.Source filing
ZB021 — IND submission
2026
Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026.Source filing
ZB022 — IND submission
2026
Zenas expects to submit an IND and initiate Phase 1 clinical development in 2026.Source filing
obexelimab — Regulatory decision
H2 2026
We also intend to submit a Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMA") in the second half of 2026.Source filing
obexelimab — NDA/BLA submission
H2 2026
Zenas expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second half of 2026.Source filing
ZB021 — Initial data
by year-end
ZB021 (oral IL-17AA/AF inhibitor) dosing ongoing in Phase 1 trial; initial clinical data expected by year-endSource filing
obexelimab — Topline data
Q4 2026
Obexelimab global Phase 2 SunStone SLE trial topline results expected in Q4 2026Source filing
obexelimab — Filing acceptance
May 27
The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027.Source filing
obexelimab — PDUFA
May 27
Obexelimab BLA submission for the treatment of IgG4-RD accepted by FDA; PDUFA target action date of May 27, 2027Source filing
Orelabrutinib — Conference presentation
Oct 21–Oct 23
Four Orelabrutinib abstracts accepted for poster presentation at MSToronto 2026Source filing