Exelixis Stock Slips as FDA Delays Cancer Drug Review, Analyst Weighs In

On Friday, the U.S. Food and Drug Administration (FDA) extended the review period for Exelixis Inc . ‘s (NASDAQ: EXEL ) new drug application (NDA) for zanzalintinib, in combination with atezolizumab, for metastatic colorectal cancer by three months.

In response to an FDA information request, Exelixis submitted updated safety and efficacy data, which the FDA has deemed a major amendment. The updated Prescription Drug User Fee Act action date is March 3, 2027.

William Blair on Friday wrote, “While we are surprised by the three-month delay, we believe the risk of rejection remains low, given that the combination of zanzalintinib plus Tecentriq demonstrated an overall survival (OS) benefit across the intent-to-treat population ...