Upcoming FDA decision · May 27, 2027
Obexelimab PDUFA date: FDA decision expected May 27, 2027
221 days to goZenas BioPharma, Inc. (ZBIO) →
The FDA is expected to decide on Obexelimab from Zenas BioPharma, Inc. in IgG4-RD accepted by FDA; PDUFA target action date of May 27 by the PDUFA target action date of May 27, 2027. For IgG4-RD accepted by FDA; PDUFA target action date of May 27. bla filing. Extracted from SEC filing: EXHIBIT 99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
May 27
Target action date
Phase 3
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for Obexelimab?
- The FDA's PDUFA target action date for Obexelimab is May 27, 2027. The FDA can act before that date, and the review can be extended.
- What is Obexelimab being reviewed for?
- The application under FDA review covers IgG4-RD accepted by FDA; PDUFA target action date of May 27.
- Which company is developing Obexelimab?
- Zenas BioPharma, Inc. (ZBIO).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).