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Obexelimab

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

Obexelimab is a Zenas BioPharma, Inc. program in igG4-related disease. Its PDUFA date is May 27, 2027, the FDA's goal date to complete review of the application. Every date links its source.

ZBIO catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: IgG4-related disease. Sponsor: Zenas BioPharma, Inc. (ZBIO). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · May 27, 2027ZBIO

Specialist biotech funds holding ZBIO, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
EcoR1 Capital789,500$20.0 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is Obexelimab's next FDA decision or readout?

Obexelimab's PDUFA date is May 27, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Obexelimab's most recent FDA decision?

No FDA decision for Obexelimab is in our archive yet.

What is Obexelimab used for?

In our records Obexelimab is under review or in development for IgG4-related disease.

Who makes Obexelimab?

Zenas BioPharma, Inc. (ZBIO).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.