Exelixis announced that the FDA extended the review period for its new drug application (NDA) for zanzalintinib, in combination with atezolizumab, to treat metastatic colorectal cancer. The extension was triggered by an FDA information request regarding updated safety and efficacy data submitted by Exelixis, which the agency classified as a major amendment. Consequently, the new Prescription Drug User Fee Act (PDUFA) action date is March 3, 2027. This regulatory delay impacts the timeline for potential commercialization of the drug candidate. Exelixis operates in the biotechnology industry, focusing on the discovery and development of targeted therapies for cancer.

On August 31, 2026, Exelixis announced that the U.S. Court of Appeals for the Federal Circuit affirmed a District Court judgment upholding the validity of three key patents: Nos. 11,091,439, 11,091,440, and 11,098,015, while dismissing as moot an appeal regarding Patent No. 11,298,349. The ruling delays the earliest effective date for any FDA approval of competitor MSN Laboratories' generic ANDA until January 15, 2030, aligning with the expiration of the affirmed patents. This legal victory preserves Exelixis's market exclusivity and revenue protection for its branded products against generic competition in the oncology sector.

Exelixis reported second quarter 2026 financial results with total revenues of $628.7 million and net product revenues of $573.0 million, driven by a $573.0 million contribution from the cabozantinib franchise in the U.S. GAAP diluted EPS was $0.82, while non-GAAP diluted EPS reached $0.91. The company updated its full-year 2026 guidance, lowering total revenue expectations to $2.500 billion–$2.550 billion and R&D expenses to $825 million–$875 million. Exelixis completed a $750 million stock repurchase program authorized in October 2025 and received Board approval for an additional $750 million buyback through December 31, 2027. Pipeline updates included the FDA-assigned PDUFA date of December 3, 2026, for zanzalintinib in metastatic colorectal cancer and ongoing pivotal trials for various oncology indications. Exelixis is a biopharmaceutical company focused on discovering and developing targeted therapies for cancer.