Upcoming FDA decision · December 3, 2026
Zanzalintinib PDUFA date: FDA decision expected December 3, 2026
46 days to goExelixis, Inc. (EXEL) →
The FDA is expected to decide on Zanzalintinib from Exelixis, Inc. in patients with metastatic CRC who have been previously treated with fluoropyrimidine- by the PDUFA target action date of December 3, 2026. For patients with metastatic CRC who have been previously treated with fluoropyrimidine-. nda filing. Extracted from SEC filing: EX-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.
December 3
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Zanzalintinib?
- The FDA's PDUFA target action date for Zanzalintinib is December 3, 2026. The FDA can act before that date, and the review can be extended.
- What is Zanzalintinib being reviewed for?
- The application under FDA review covers patients with metastatic CRC who have been previously treated with fluoropyrimidine-.
- Which company is developing Zanzalintinib?
- Exelixis, Inc. (EXEL).
- 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).