Exelixis (NASDAQ:EXEL) President and CEO Michael Morrissey said the company is focused on expanding its oncology franchises through internal development, selective business development and potential collaborations, while preparing for a planned launch of zanzalintinib in metastatic colorectal cancer.
Speaking at Morgan Stanley’s Global Healthcare Conference, Morrissey said innovation originating in China has become an important consideration for the biotechnology industry. Exelixis is evaluating external opportunities, including assets from outside the United States, but is prioritizing novel programs over “fast followers” or “me-too” products.
AI Use Focused on Curated Data
Morrissey said Exelixis is adopting artificial intelligence in a measured way rather than broadly increasing spending across its operations. The company is targeting uses of AI where it has highly curated data sets, including data from discovery, clinical development and commercial activities.
He said the company has accumulated decades of longitudinal data and is using AI to improve the speed, depth and utility of its analyses. Commercial applications may be particularly valuable, he said, while security remains a core consideration alongside speed and data quality.
“I do not think we’re spending a lot of money, but I think we’re doing the right level of investments and the right focusing in terms of priorities to maximize impact,” Morrissey said.
On policy, Morrissey said drug pricing and most-favored-nation issues are among the leading concerns for Exelixis and the broader industry. He said the regulatory and political environment remains highly dynamic, with potential changes in Congress and future administrations creating uncertainty. The company maintains a policy team in Washington and engages with lawmakers on pricing, regulatory issues and competitive threats, he said.
Cabozantinib Remains a Major Growth Driver
Morrissey said Exelixis’ cabozantinib business remains strong, with a global annualized run rate above $3 billion based on the company’s second-quarter 2026 results. Cabozantinib has been evaluated in numerous pivotal trials and has approvals across eight indications, he said.
The company recently added neuroendocrine tumors, or NET, to the cabozantinib franchise. Morrissey said growth in the indication has been somewhat slower than expected but does not change Exelixis’ long-term outlook.
Exelixis has settled with several generic manufacturers on a Jan. 1, 2031, entry date for cabozantinib. The company continues to litigate with other challengers and said a recent appellate decision supported its position. Morrissey said the company is not particularly concerned about potential 505(b)(2) competitors, which he said would face difficulty gaining adoption without significant clinical investment and data.
Zanzalintinib Launch Preparation Continues
Exelixis is preparing to launch zanzalintinib in metastatic colorectal cancer following the STELLAR-303 study. Morrissey said the regulatory review timeline was extended, with the company setting the PDUFA date to March 3, as disclosed in a recent filing. He did not provide additional details beyond the company’s 8-K filing.
The delay has not changed Exelixis’ confidence in the opportunity or its resource allocation, Morrissey said. The company considers itself launch-ready and had previously expanded its gastrointestinal sales force in anticipation of a colorectal cancer launch.
Morrissey said STELLAR-303 was the only successful study among five recent trials testing checkpoint-based platform therapies in third-line or later non-MSI-high colorectal cancer. The trial evaluated zanzalintinib in combination with atezolizumab.
He said the company believes zanzalintinib’s kinase inhibition profile can affect multiple components of the tumor microenvironment, including tumor vasculature and immune cells. Exelixis views the STELLAR-303 results and its STELLAR-316 maintenance-focused trial as complementary parts of a broader colorectal cancer franchise strategy.
The late-line colorectal cancer setting represents approximately 23,000 patients and a $1.5 billion opportunity, according to the Morgan Stanley moderator. Morrissey said Exelixis has substantial overlap with its existing commercial infrastructure and is using sales, marketing and analytics capabilities to support the expected launch.
Broader Development Programs
In renal cell carcinoma, Morrissey said STELLAR-304 is the first global randomized pivotal trial in non-clear-cell disease, an area he described as understudied. The trial uses sunitinib as a control arm. Exelixis is also conducting studies of zanzalintinib with belzutifan through its collaboration with Merck.
Morrissey said Exelixis is exploring additional frontline combinations, including possible bispecific antibodies and cancer vaccines. The company has an investigator-sponsored trial with Dana-Farber evaluating zanzalintinib alongside a peptide vaccine program.
For NET, he said STELLAR-311 is comparing zanzalintinib directly with everolimus, unlike the placebo-controlled CABINET trial for cabozantinib. Morrissey said the study is enrolling ahead of schedule and could expand the NET opportunity rather than simply transition existing cabozantinib patients.
Exelixis also has early-stage antibody-drug conjugate, small-molecule and bispecific programs advancing toward development decisions. Morrissey said the company will remain data-driven in determining whether to advance or discontinue programs, regardless of whether an asset originated internally or through business development.
“We just need a small number of winners,” Morrissey said. “We don’t need a big pipeline of unknowns.”
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.
