Shares of Exelixis Inc (NASDAQ:EXEL) moved lower in premarket trading on Friday, falling 3.5% after the company disclosed that U.S. regulators had lengthened the review timeline for its cancer therapy candidate.
The U.S. Food and Drug Administration notified Exelixis on September 10, 2026, that it was extending the review period for the company’s new drug application (NDA) for zanzalintinib, when given in combination with the immunotherapy atezolizumab, intended for patients with metastatic colorectal cancer. The agency said the change followed Exelixis’ submission of updated safety and efficacy information in response to an FDA information request. The FDA characterized that submission as a major amendment.
As a result, the updated Prescription Drug User Fee Act (PDUFA) action date is now March 3, 2027, reflecting a three-month deferral from the original timetable.
Zanzalintinib is under evaluation in combination with atezolizumab as a possible treatment option for metastatic colorectal cancer. Company disclosures indicate the FDA’s decision to extend the review is procedural in nature and was prompted by the additional data filing rather than the agency identifying specific safety or efficacy concerns in public statements from Exelixis.
The extension delays the potential approval and the timeline for commercial rollout of the drug candidate. That postponement may affect Exelixis’ near-term revenue projections and market expectations for the company, as the commercialization window has been pushed back by roughly three months.
Market participants often react to regulatory timetable changes because they can shift anticipated cash flows and go-to-market plans. In this instance, the company’s stock moved lower immediately after the disclosure, reflecting an adjustment in investor expectations tied to the delayed PDUFA date.
Summary
The FDA extended its review of Exelixis’ NDA for zanzalintinib plus atezolizumab by three months after Exelixis submitted updated safety and efficacy data that the agency treated as a major amendment. The revised PDUFA date is March 3, 2027, and the company’s stock fell 3.5% in premarket trading following the announcement.