EXELIXIS, INC. 8-K filed 2026-09-11

Exelixis, Inc. (ticker EXEL on Nasdaq) filed this 8-K on 2026-09-11 under Item 8.01, Other Events. It discloses that on September 10, 2026, the U.S. Food and Drug Administration notified the company that it had extended the review period for Exelixis' new drug application for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic colorectal cancer. The extension is three months. The filing gives the reason. In response to an FDA information request, Exelixis submitted updated safety and efficacy data, and the FDA deemed that submission a major amendment. The updated Prescription Drug User Fee Act action date is March 3, 2027. For an analyst or journalist following this application, that is the date by which the FDA is now scheduled to act. The filing does not state the original action date, the contents of the FDA's information request, or what the updated safety and efficacy data show. It also does not say whether the extension affects the company's financial guidance or plans. The document is signed by Brenda J. Hefti, Senior Vice President and General Counsel, and the full filing is available at the source link.