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FDA Delays Decision on Exelixis Cancer Drug by Three Months

News|2026/09/11 14:10
FDA Delays Decision on Exelixis Cancer Drug by Three Months

The news pushed Exelixis stock out of its buy zone.

Exelixis (EXEL) shares fell on Friday after the Food and Drug Administration delayed by three months a potential approval decision for the company’s new colon cancer treatment.

The combination therapy includes Exelixis’ zanzalintinib and Roche’s (RHHBY) Tecentriq.

William Blair analyst Andy Hsieh said it is unlikely that the agency will outright reject the combination. According to his assessment, the regimen showed an overall survival benefit in studies.

Still, investors reacted negatively to the surprise delay, pushing Exelixis stock out of its buy zone.

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