EXEL

Zanzalintinib (XL-092) + atezolizumab

FDA PDUFA Target Action Date · Exelixis, Inc.

Thursday, December 3, 2026

138 days away

Drug Information

Drug Name: Zanzalintinib (XL-092) + atezolizumab (CT.gov)
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.

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Data sourced from SEC EDGAR filings. Last updated: 2026-04-10. Report an issue