Cabozantinib PDUFA date: FDA decision expected March 3, 2027
The FDA is expected to decide on Cabozantinib from Exelixis, Inc. in Solid Tumors by the PDUFA target action date of March 3, 2027. 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 29, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for Cabozantinib?
- The FDA's PDUFA target action date for Cabozantinib is March 3, 2027. The FDA can act before that date, and the review can be extended.
- What is Cabozantinib being reviewed for?
- The application under FDA review covers Solid Tumors.
- Which company is developing Cabozantinib?
- 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).