Exelixis Inc (NASDAQ:EXEL) shares fell 3.5% in premarket trading Friday after the company said the US Food and Drug Administration extended the review period for its new drug application for zanzalintinib by three months.
The FDA notified Exelixis on September 10, 2026, of the extension for the application covering zanzalintinib in combination with atezolizumab for patients with metastatic colorectal cancer.
According to the company, the extension followed its submission of updated safety and efficacy data in response to an FDA information request. The agency classified the submission as a major amendment.
The Prescription Drug User Fee Act action date has been moved to March 3, 2027, three months later than the previous review timeline.
Zanzalintinib is being evaluated in combination with atezolizumab as a treatment for metastatic colorectal cancer. The source did not identify any specific safety or efficacy concern associated with the FDA’s decision to extend the review period.
The three-month extension moves the regulatory decision to March 2027, with the application remaining under FDA review.