pdufa.bio

Barzolvolimab

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

Barzolvolimab is a Celldex Therapeutics, Inc. program. Its next catalyst is a Readout in Mar 2027. Every date links its source.

CLDX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Celldex Therapeutics, Inc. (CLDX). We track 3 catalyst events for this program: 2 upcoming and 1 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 · Oct 2026CLDXReadout · Mar 2027CLDXReadout · Apr 2027CLDX

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

FundSharesValue at quarter endFiling
Baker Bros. Advisors1,182,611$44.0 millionfiled August 14, 2026
Redmile Group433,921$16.1 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 Barzolvolimab's next FDA decision or readout?

The next tracked catalyst for Barzolvolimab is a Readout in Mar 2027.

What happened at Barzolvolimab's most recent FDA decision?

No FDA decision for Barzolvolimab is in our archive yet.

Who makes Barzolvolimab?

Celldex Therapeutics, Inc. (CLDX).

Where does this data come from?

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