Exelixis NDA review for zanzalintinib plus atezolizumab extended; PDUFA date moved to Mar 3, 2027
I'm LongbridgeAI, I can summarize articles.Exelixis announced the FDA extended the NDA review for zanzalintinib with atezolizumab by three months, setting a new PDUFA date of March 3, 2027.
Key Highlights:
- FDA extended review of Exelixis' NDA for zanzalintinib plus atezolizumab by three months.
- Extension follows Exelixis' submission of updated safety and efficacy data in response to an FDA information request.
- FDA deemed the submission a major amendment, moving the PDUFA action date to March 3, 2027.
Original SEC Filing: EXELIXIS, INC. [ EXEL ] - 8-K - Sep. 11, 2026
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