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pdufa.bio

Cabozantinib

Updated ยทnext FDA decision on the calendar

Cabozantinib is a Exelixis program. Its next catalyst is a Readout in Dec 2026. 2 FDA decisions on record below. Every date links its source.

EXEL catalyst hub · IPSEY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Cabozantinib is marketed as CABOMETYX (cabozantinib); the events below include those tracked under the brand name. Sponsor: Exelixis (EXEL, IPSEY). We track 6 catalyst events for this program: 2 upcoming and 4 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 · Mar 26, 2025 ✓ ApprovedEXELPDUFA · Mar 26, 2025 ✓ ApprovedIPSEYReadout · Jul 2026EXELReadout · Sep 2026EXELReadout · Dec 2026EXELReadout · Jan 2027EXEL

Questions

When is Cabozantinib's next FDA decision or readout?

The next tracked catalyst for Cabozantinib is a Readout in Dec 2026.

What happened at Cabozantinib's most recent FDA decision?

On Mar 26, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Cabozantinib?

Exelixis (EXEL, IPSEY).

Has Cabozantinib been approved by the FDA?

Yes. The FDA approved an application for Cabozantinib on Mar 26, 2025; the decision page linked above carries the source.

Where does this data come from?

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