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Healthcare

Exelixis Inc.

09/11/2026 | Press release | Distributed by Public on 09/11/2026 05:00

Material Event (Form 8-K)

Item 8.01. Other Events.

Today, 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.

Exelixis Inc. published this content on September 11, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on September 11, 2026 at 11:01 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]