pdufa.bio

ZB021

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

ZB021 is a Zenas BioPharma, Inc. program. Its next catalyst is a Readout in Q4 2026. Every date links its source.

ZBIO catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Zenas BioPharma, Inc. (ZBIO). 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

Readout · Q4 2026ZBIO

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 ZB021's next FDA decision or readout?

The next tracked catalyst for ZB021 is a Readout in Q4 2026.

What happened at ZB021's most recent FDA decision?

No FDA decision for ZB021 is in our archive yet.

Who makes ZB021?

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.