Thursday, December 3, 2026
191 days away
Drug Information
- Application Type
- NDA
- Indication
- Pretreated metastatic colorectal cancer (mCRC)
Filing Details
- Company
- Exelixis, Inc. →
- Stock Ticker
- EXEL
- SEC CIK
- 0000939767
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore Exelixis, Inc.
View Exelixis, Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-04-10. Report an issue