Every 8-K that Exelixis Inc (EXEL) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow EXEL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full EXEL filings page.
Exelixis, Inc. (EXEL) reports that the U.S. Food and Drug Administration has extended by three months the review period for its new drug application for zanzalintinib, in combination with atezolizumab, for patients with metastatic colorectal cancer. The updated Prescription Drug User Fee Act action date is March 3, 2027.
The FDA deemed updated safety and efficacy data submitted by Exelixis to be a major amendment, which triggered the extension of the review timeline.
EXELIXIS, INC. (EXEL) reports a favorable appellate ruling in its cabozantinib patent litigation against MSN Laboratories. On August 31, 2026, the U.S. Court of Appeals for the Federal Circuit affirmed a Delaware district court judgment that U.S. Patent Nos. 11,091,439, 11,091,440 and 11,098,015 are not invalid and dismissed as moot MSN’s appeal regarding U.S. Patent No. 11,298,349, which expires on February 10, 2032.
Based on the ruling, the effective date of any final FDA approval of MSN’s ANDA for its proposed generic product may not be earlier than January 15, 2030, the expiration date of the three affirmed patents, subject to further appeals, regulatory exclusivity, and separate litigation over U.S. Patent No. 12,128,039, which expires in February 2032 and has a trial scheduled to begin in November 2026.
Exelixis reported higher second-quarter 2026 results. Total revenues were $628.7 million, including $573.0 million of U.S. cabozantinib franchise net product revenues and $55.7 million of collaboration revenues. GAAP net income was $212.1 million, or $0.82 per diluted share, and non-GAAP net income was $237.1 million, or $0.91 per diluted share.
Full-year 2026 guidance was updated. The company now projects total revenues of $2.500–$2.550 billion and net product revenues of $2.300–$2.350 billion, with research and development expenses of $825–$875 million, selling, general and administrative expenses of $575–$625 million, cost of goods sold at 3.5%–4.5% of net product revenues, and an effective tax rate of 21%–23%.
Pipeline and capital allocation remain active. Zanzalintinib is under U.S. regulatory review for previously treated metastatic colorectal cancer, with a Prescription Drug User Fee Act target action date of December 3, 2026, and multiple phase 2 and 3 trials are ongoing or planned across several tumor types. Exelixis repurchased $311.6 million of stock in the quarter at an average price of $47.85, completing a $750 million program, and has a new authorization to repurchase up to an additional $750 million by December 31, 2027, bringing cumulative repurchases since 2023 to $2.9 billion and 93.3 million shares.
Exelixis, Inc. reported the results of its 2026 annual stockholder meeting. Stockholders approved an amended and restated 2017 Equity Incentive Plan, which became effective immediately upon approval. All 11 director nominees were elected to serve until the next annual meeting in 2027.
Stockholders ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending January 1, 2027. They also approved, on an advisory basis, the compensation of Exelixis’ named executive officers, confirming support for the company’s current governance and compensation framework.
Exelixis reported strong first quarter 2026 results and expanded its stock repurchase plans. Total revenues were $610.8 million, up from $555.4 million a year earlier, driven by net product revenues of $555.0 million, largely from the U.S. cabozantinib franchise. GAAP net income was $210.5 million, or $0.79 per diluted share, while non-GAAP diluted EPS was $0.87.
The company reaffirmed 2026 guidance, including total revenues of $2.525–$2.625 billion and net product revenues of $2.325–$2.425 billion, with an effective tax rate of 21–23%. Exelixis’ board authorized a new $750 million stock repurchase program through December 31, 2027, after repurchasing $590.6 million under its October 2025 program and $2.59 billion cumulatively since March 2023, retiring 86.8 million shares.
Pipeline momentum continued as the FDA accepted the NDA for zanzalintinib in previously treated metastatic colorectal cancer, with a PDUFA target action date of December 3, 2026. Multiple pivotal trials, including STELLAR-303, STELLAR-304, STELLAR-311, STELLAR-316 and Merck’s LITESPARK-033 and -034, are underway or planned across colorectal, renal cell, neuroendocrine and other tumors.
Exelixis reported stronger results for 2025, with total revenues of $2.32 billion versus $2.17 billion in 2024, driven mainly by its cabozantinib cancer franchise. U.S. cabozantinib net product revenues reached $2.12 billion, and global franchise revenues with partners totaled $2.9 billion.
GAAP net income rose to $782.6 million, or $2.78 diluted EPS, up from $1.76 a year earlier; non-GAAP diluted EPS was $3.08. Fourth quarter diluted EPS was $0.88 GAAP and $0.94 non-GAAP. The company repurchased $264.5 million of stock in Q4 and has retired 76.7 million shares cumulatively.
For 2026, Exelixis guides total revenues to $2.525–$2.625 billion and net product revenues to $2.325–$2.425 billion. The FDA has accepted its NDA for zanzalintinib in previously treated metastatic colorectal cancer, with a PDUFA target date of December 3, 2026, and multiple pivotal zanzalintinib trials are advancing.
Exelixis, Inc. filed a current report to disclose that on January 11, 2026 it issued a press release with preliminary, unaudited financial results for the fiscal year ended January 2, 2026. The release also provided financial guidance for the fiscal year ending January 1, 2027 and included an update on the company’s business.
The company notes that the audit of its fiscal 2025 financial statements is ongoing and could lead to changes in the information contained in the press release. Exelixis states it plans to report its audited financial results for the fiscal year ended January 2, 2026 on February 10, 2026. The press release is furnished as Exhibit 99.1 and is not deemed filed for liability purposes.
Exelixis (EXEL) announced a leadership transition in its legal team. Executive Vice President and General Counsel Jeffrey Hessekiel, J.D., notified the company of his intention to resign effective in November 2025 and will cease serving as General Counsel on November 7, 2025. The company stated his decision was not due to any disagreement.
Brenda Hefti, J.D., Ph.D., currently Senior Vice President, IP & Licensing, will be promoted to General Counsel effective November 7, 2025, reporting to President and CEO Michael Morrissey, Ph.D. Dr. Hefti joined Exelixis in 2013, became Head of IP in 2014, and has served as SVP, IP & Licensing since 2020.
Exelixis (EXEL) reported quarterly results via a press release for the quarter ended October 3, 2025, which was furnished as Exhibit 99.1. The company also provided a corporate update.
The Board authorized a stock repurchase program allowing Exelixis to buy back up to $750 million of its common stock before December 31, 2026. This authorization sets a ceiling and timeframe for potential repurchases.
On August 29, 2025, Exelixis, Inc. announced an internal leadership change: Dana T. Aftab, Ph.D., currently the company’s Executive Vice President, Discovery and Translational Research and Chief Scientific Officer, was appointed Executive Vice President, Research and Development. The filing states information about Dr. Aftab’s background, compensation arrangements, and any related-party transactions is incorporated by reference from the company’s definitive proxy statement on Schedule 14A filed April 16, 2025. Effective the same day, Amy C. Peterson, M.D., concluded her service as Executive Vice President, Product Development and Medical Affairs and Chief Medical Officer, and is entitled to payments under the company’s Change in Control and Severance Benefit Plan, as amended, and applicable law.