{"url_path":"/sec/exel/8-k/2026-09-11/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-09-11","source_url":"https://www.sec.gov/Archives/edgar/data/939767/0000939767-26-000108-index.html","accession_number":"0000939767-26-000108","cik":"0000939767","ticker":"EXEL","issuer_name":"EXELIXIS, INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/939767/0000939767-26-000108-index.html","primary_entity_key":"0000939767","primary_entity_name":"EXELIXIS, INC."},"word_count":139,"has_tables":true,"body_markdown":"Item 8.01. Other Events.\n\nToday, Exelixis, Inc. (Exelixis) announced that on September 10, 2026, the U.S. Food and Drug Administration (FDA) notified Exelixis that it had extended the review period for Exelixis’ new drug application (NDA) for zanzalintinib, in combination with atezolizumab, for the treatment of patients with metastatic colorectal cancer by three months. In response to an FDA information request, Exelixis had 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.\n\nSIGNATURES\n\nPursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.\n\nEXELIXIS, INC.\n\nSeptember 11, 2026\n/s/ Brenda J. Hefti\n\nDateBrenda J. Hefti\n\nSenior Vice President and General Counsel"}