Exelixis Eyes Zanza Launch as CABOMETYX Growth Faces NET Ramp Hurdle

Key Points

• CABOMETYX growth remains a focus, with Exelixis targeting a potential $3 billion franchise through deeper penetration in renal cell carcinoma and neuroendocrine tumors. However, the NET rollout has been slower than expected because treatment decisions occur less frequently in the typically indolent disease.
• Exelixis is preparing for a potential late-year launch of zanzalintinib (zanza) in third-line colorectal cancer, a market the company estimates at approximately $1.5 billion. The company expects approval-related launch expenses to be covered in its guidance and is developing additional zanza combinations in RCC and NET.
• The company assumes CABOMETYX generics will enter on Jan. 1, 2031 under existing settlements and does not view 505(b)(2) competitors as a major near-term threat. Capital allocation remains centered on research and development, business development and share repurchases, with about $600 million left under its buyback authorization.

Exelixis NASDAQ: EXEL executives outlined plans to continue expanding the CABOMETYX franchise while preparing for a potential launch of zanzalintinib, or zanza, in colorectal cancer later this year.

Speaking at a Wells biotech session, Chief Financial Officer Chris Senner said the company is working to deepen penetration for CABOMETYX in renal cell carcinoma, or RCC, and in neuroendocrine tumors, or NET, following the NET indication launch last year. He said zanza development remains central to the company’s outlook heading into 2027.

Andrew Peters, senior vice president of strategy, described 2026 as a transition period in which Exelixis is seeking to grow its CABOMETYX business while investing in zanza and earlier-stage pipeline programs. The company is also considering external business-development opportunities and share repurchases as part of its capital-allocation strategy.

CABOMETYX Growth Outlook and NET Launch Dynamics

Senner said Exelixis continues to view a $3 billion CABOMETYX franchise as achievable, with RCC and NET contributing to growth through 2027, 2028 and 2029. The company has described the NET opportunity as roughly a $1 billion oral-drug market at contemporary pricing.

However, executives said the company’s reduced CABOMETYX guidance and second-quarter revenue performance reflected a slower-than-expected ramp in NET. Senner attributed the pace to the relatively indolent nature of the disease, where patients may have longer intervals between scans and between treatment decisions than patients with other solid tumors.

Peters said CABOMETYX was capturing approximately 47% of new-patient market share in NET, characterizing that measure as a leading indicator of long-term adoption. He said the issue was primarily “a temporal dynamic” between new-patient share and overall market share, rather than a change in the underlying market opportunity.

The company said it expanded its sales force earlier this year, with the team largely in place by the end of the first quarter. Senner said the expansion began affecting NET performance in the second quarter and is expected to continue supporting commercialization efforts.

Patent Planning and Competitive Landscape

Peters said Exelixis does not view 505(b)(2) products, including a tentatively approved CABOMETYX-like therapy from Handa Pharmaceuticals, as a meaningful commercial risk to its CABOMETYX business. He said such products have historically faced commercial challenges when they lack clinical data, are not AB-rated, and are not interchangeable or substitutable with the reference product.

Exelixis is focused on patient safety and enforcing its intellectual-property rights where appropriate, Peters said.

For planning purposes, the company assumes CABOMETYX generics will enter the market on Jan. 1, 2031, based on announced settlements with Teva, Cipla and others. Peters said litigation and legal challenges can continue before then, but described the 2031 date as the most appropriate assumption for company planning.

Zanza Launch Preparation and Clinical Programs

Exelixis said it is preparing to launch zanza immediately if it receives approval in colorectal cancer following its PDUFA date. Senner said launch expenses are included in company guidance and the commercial organization is preparing through advisory boards and market work.

Peters said the company’s regulatory filing for zanza in colorectal cancer was based on the intent-to-treat population from the STELLAR-303 study, including patients with and without liver metastases. He said data presented at ESMO and subsequently published showed consistent benefit across subpopulations.

The company has described the third-line-and-beyond colorectal cancer market as an approximately $1.5 billion opportunity. Peters said Exelixis aims to reach as much of that market as possible, citing interest in a chemotherapy-free, checkpoint-containing treatment option and the potential benefit regardless of prior Avastin use.

Exelixis has not disclosed specific pricing plans for zanza. Senner said pricing would be “contemporary” with more recent market practices and would be determined using multiple metrics.

In RCC, Exelixis is developing zanza combinations in the LITESPARK-033 and LITESPARK-034 studies with partner Merck. Peters said the programs target areas of unmet need, including patients who progress after adjuvant pembrolizumab and later-line RCC treatment. The company also sees an opportunity in non-clear cell RCC through STELLAR-304, which excludes the chromophobe subpopulation and seeks to establish level-one evidence in a setting where treatment decisions have often relied on smaller, unrandomized studies.

Pipeline and Capital Allocation

Exelixis continues to view NET as a core franchise and is investing in zanza through the STELLAR-311 first-line NET study. Peters said the slower commercial kinetics in second-line NET have not changed the company’s view of the broader NET opportunity or its approach to STELLAR-311 enrollment.

In meningioma, Peters said a phase 2 study could potentially support an accelerated-approval path if it produces a robust response rate, though he emphasized that any regulatory strategy would be data-dependent. The study’s primary endpoint is response rate, with duration of response, progression-free survival and overall survival among secondary measures.

Senner said capital allocation remains focused on three areas:

• Annual research and development spending of $1 billion or less;
• Business-development opportunities, primarily in gastrointestinal and genitourinary areas; and
• Share repurchases.

Through the second quarter of 2026, Exelixis had repurchased approximately $2.9 billion of stock since the second quarter of 2023, retiring about 90 million shares. The company had approximately $600 million remaining under its current repurchase authorization as of the end of the last quarter, Senner said.

About Exelixis (NASDAQ:EXEL)

Exelixis, Inc NASDAQ: EXEL is a biopharmaceutical company focused on discovering, developing and commercializing medicines for cancer and other serious diseases. The company's research and development activities center on targeted therapies designed to address biological pathways involved in tumor growth and progression.

Exelixis' principal product is cabozantinib, marketed in the United States as CABOMETYX tablets for certain patients with advanced renal cell carcinoma, hepatocellular carcinoma and radioactive iodine-refractory differentiated thyroid cancer.

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