Zenas BioPharma ZBIO
Zenas BioPharma (Nasdaq: ZBIO) is an immunology/inflammation drug developer. Its lead program, obexelimab, is in Phase 3 for IgG4-related disease (IgG4-RD). Its next catalyst on record is obexelimab (IgG4-RD): PDUFA target date (May 2027).
Upcoming catalysts
- May 2027obexelimab (IgG4-RD) — PDUFA target date
In August 2026, the FDA accepted our BLA and assigned a Prescription Drug User Fee Act ('PDUFA') target date of May 27, 2027.
Next further out: obexelimab (SLE) — Topline results including biomarker data (Q4 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| obexelimab | IgG4-related disease (IgG4-RD) | antibody | Phase 3 |
| orelabrutinib | primary progressive multiple sclerosis (PPMS) | small molecule | Phase 3 |
| orelabrutinib | non-active secondary progressive multiple sclerosis (naSPMS) | small molecule | Phase 3 |
| obexelimab | relapsing multiple sclerosis (RMS) | antibody | Phase 2 |
| obexelimab | systemic lupus erythematosus (SLE) | antibody | Phase 2 |
| ZB021 | immunology/inflammation (unspecified) | small molecule | Phase 1 |
| ZB022 | immunology/inflammation (unspecified) | small molecule | Pre-clinical |
| ZB014 | immunology/inflammation (unspecified) | antibody | Pre-clinical |
| ZB002 | immunology/inflammation (unspecified) | unclear | Pre-clinical |
| ZB004 | immunology/inflammation (unspecified) | unclear | Pre-clinical |
Recent results and decisions
- Nov 5, 2026submitted EMA validated the Marketing Authorization Application for obexelimab for the treatment of IgG4-RD.
The European Medicines Agency (EMA) validated the recently submitted Marketing Authorization Application (MAA) for the treatment of IgG4-RD.
Filing - Nov 5, 2026started ZB021 dosing ongoing in Phase 1 trial evaluating safety, tolerability, and pharmacokinetics in healthy volunteers.
Dosing is ongoing in the single ascending dose (SAD) and now the multiple ascending dose (MAD) parts of the Phase 1 trial designed to evaluate the safety, tolerability, and pharmacokinetic profile of ZB021 in healthy volunteers.
Filing - 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
7 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
- Sanofi SNY
- Argenx SE ARGX
- Roivant Sciences Ltd. ROIV
- Immunovant, Inc. IMVT
- Celldex Therapeutics, Inc. CLDX
- Biohaven Ltd. BHVN
- BioCryst Pharmaceuticals, Inc. BCRX
- Nektar Therapeutics NKTR
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.