EXEL Stock Slides After FDA Adds Three Months To Cancer Drug Review — William Blair Sees More Swings In Near Term

The FDA told Exelixis on Thursday that it had extended the review of a new drug application for zanzalintinib plus Roche’s Tecentriq in patients whose colorectal cancer has spread.

• The FDA will now decide on Exelixis’s new application by March 3, 2027.
• A March decision would push a possible U.S. launch out of this year and into 2027. 
• William Blair said it was “surprised” by the three-month delay but still sees a low chance of an outright rejection, because the combination showed a survival benefit in the main study group.

Shares of Exelixis (EXEL) fell 2% on Friday after the company said U.S. regulators added three months to the review of its next cancer drug, but William Blair still sees a low chance of an outright rejection.

The Food and Drug Administration told Exelixis on Thursday that it had extended the review of a new drug application for zanzalintinib plus Roche’s Tecentriq in patients whose colorectal cancer has spread, the company said in a filing with the Securities and Exchange Commission on Friday. The new target decision date is March 3, 2027. The old date was December 3, 2026. A March decision would push a possible U.S. launch out of this year and into 2027.

Why The Clock Moved

The FDA asked for more information and Exelixis sent updated safety and efficacy results, the company said. The agency treated that package as a major change to the application and extended its review period.

The FDA accepted Exelixis’s application in February for adults with metastatic colorectal cancer who had already received standard chemotherapy. Patients whose tumors lacked a common RAS mutation also had to have tried a separate targeted drug first.

The filing rests on STELLAR-303, a late-stage study that tested Exelixis’s oral drug with Tecentriq against Bayer’s Stivarga. In the full study population, patients on the combination lived longer.

Doubt remains because a second, pre-set test missed its mark. In June, Exelixis said patients without active liver tumors showed a similar trend but not a statistically clear survival win. Investors have worried the mixed result could slow the review, narrow the label, or invite extra questions. Friday’s filing did not say the new data requested by the FDA came from that subgroup.

Analyst Shrugs Off Rejection Risk

William Blair said it was “surprised” by the three-month delay but still sees a low chance of an outright rejection, because the combination showed a survival benefit in the main study group. The firm said the extra wait should not materially cut the drug’s long-term sales, though the stock may swing more in the near term. It kept an ‘Outperform’ rating.

Zanzalintinib is Exelixis’s bid for a second commercial franchise after Cabometyx, the cabozantinib tablet that still accounts for nearly all of the company’s product sales. Cabometyx is approved for kidney, liver, and neuroendocrine cancers and generated about $2.12 billion in U.S. net product revenue in 2025.

How Did EXEL Retail Traders React?

On Stocktwits, retail sentiment around EXEL stock fell from ‘neutral’ to ‘bearish’ over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.

“A delay is a delay nothing else,” a Stocktwits user said.

View this Stocktwits post

EXEL stock has gained 28% year-to-date. 

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