Exelixis Shares Fall After FDA Extends Review of Cancer Drug Zanzalintinib

Shares of Exelixis Inc. (NASDAQ: EXEL) fell in premarket trading Friday after the company disclosed that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application for zanzalintinib. The stock was down 3.5% following the announcement of the three-month delay.

Review Timeline Pushed to 2027

Exelixis announced that the FDA has set a new Prescription Drug User Fee Act (PDUFA) action date of March 3, 2027. This represents a three-month extension from the original deadline.

The new drug application is for zanzalintinib in combination with atezolizumab as a potential treatment for patients with metastatic colorectal cancer. The company stated it was notified by the FDA of the extension on September 10, 2026.

Reason for the Extension

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The delay is a procedural step following the submission of additional information by Exelixis. The company provided updated safety and efficacy data in response to an information request from the agency.

The FDA classified this submission as a major amendment to the application, which automatically extends the review timeline to allow for a full evaluation of the new data. The company did not disclose any specific new safety or efficacy concerns that prompted the extension.

Market Impact

The extension pushes back the potential approval and subsequent commercial launch of zanzalintinib, a key candidate in Exelixis' pipeline. For investors, this delay introduces uncertainty and could affect the company's near-term revenue projections and market expectations, which was reflected in the premarket stock decline.