Zenas BioPharma, Inc. ZBIO
Zenas BioPharma, Inc. (Nasdaq: ZBIO) is an immunology/inflammation drug developer. Its lead program, obexelimab, is in Phase 3 for IgG4-related disease. Its next catalyst on record is obexelimab: Topline results from the Phase 2 SunStone trial in Systemic Lupus Erythematosus expected in 4Q 2026. (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: obexelimab — Topline results from the Phase 2 SunStone trial in Systemic Lupus Erythematosus expected in 4Q 2026. (Q4 2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| obexelimab | IgG4-RD | antibody | Phase 3 |
| orelabrutinib | PPMS and nonactive SPMS | small molecule | Phase 3 |
| obexelimab | SLE (SunStone) | antibody | Phase 2 |
| obexelimab | RMS (MoonStone) | antibody | Phase 2 |
| ZB021 | IL-17 inflammatory disease | small molecule | Phase 1 |
Recent results and decisions
- Oct 13, 2026positive Obexelimab demonstrated sustained clinical activity in the Phase 3 INDIGO open-label extension with 12-month flare-free probability of 0.93 based on adjudication committee-confirmed flares.
The 12-month probability of remaining flare-free was 0.93 based upon investigator- and adjudication committee-confirmed flares requiring rescue therapy, and 0.87 based upon investigator-determined flares requiring rescue therapy.
Filing - Oct 12, 2026positive Zenas BioPharma presents new Phase 3 INDIGO open-label extension data for obexelimab in IgG4-RD showing sustained clinical activity.
The 12-month probability of remaining flare-free was 0.93 based upon investigator- and adjudication committee-confirmed flares requiring rescue therapy.
Filing - Aug 13, 2026accepted FDA accepted obexelimab BLA for IgG4-RD; PDUFA target action date May 27, 2027.
The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027.
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.