Exelixis Says FDA Action Date For Zanzalintinib Is March 3, 2027, With Kidney Data Due In First Quarter
Executives set two dates for the drug meant to be the company's second franchise, and shut down questions about talks with the agency.
Exelixis, the cancer-drug developer behind Cabometyx, said on its third-quarter earnings call Thursday that the FDA's target decision date for its zanzalintinib colorectal cancer application is now March 3, 2027, and that top-line results from a kidney-cancer trial should arrive in the first quarter of next year. The company reported total revenue of about $659 million for the quarter.
A new date and a narrow answer
Dana Aftab, Exelixis' executive vice president of research and development, said the updated action date applies to the application built on the Stellar 303 trial. Asked whether labeling talks with the FDA had begun, she said that beyond the new date she would not speculate, "for obvious reasons," on interactions with the agency "during an ongoing review."
The company's commercial chief, PJ Haley, put the third-line-plus colorectal setting at roughly 23,000 US patients, a market of about $1.5 billion at current pricing. He said about 70% of colorectal prescribers also prescribe Cabometyx, rising to 90% when shared addresses are counted.
Kidney readout and its limits
Aftab said enrollment in Stellar 304, which tests zanzalintinib plus nivolumab against sunitinib in non-clear-cell kidney cancer, finished last year. Top-line results are now expected in the first quarter, and positive data could lead to a second zanzalintinib filing.
Pressed by an analyst on event rates and the control arm, Aftab declined to give details. She said that based on events coming in, the company is "close to a clinical cutoff date."
Haley said the population is about 20% of kidney cancer patients and that, among the first-wave zanzalintinib studies, Stellar 304 is "the smallest of those."
Building a second franchise
Exelixis sells Cabometyx and Cometriq itself in the US, and cabozantinib accounts for most of its revenue. Management wants zanzalintinib to be the next franchise. Aftab said seven ongoing trials could support labeling, which the company calls wave one, and that planning for a second wave is well underway.
Cabo's momentum continues: US franchise net product revenue rose about 11% from a year earlier to $605 million, and global franchise revenue rose about 11% to $818 million. Adjusted net income was about $240 million, or $0.94 per diluted share.
The company repurchased about $250 million of stock in the quarter, retiring roughly 4.5 million shares at an average $55.77, and has about $348 million left under its $750 million authorization.
The next dated events are the Stellar 304 top-line results in the first quarter and the FDA's March 3, 2027 action date.
Sources
- Exelixis Non-GAAP EPS of $0.94 beats by $0.04, revenue of $658.7M beats by $10.19M (EXEL:NASDAQ) | Seeking Alpha — seekingalpha.com
- Exelixis (EXEL) Surpasses Q3 Earnings and Revenue Estimates — Yahoo Finance
- Exelixis: Q3 Earnings Snapshot – WTOP News — wtop.com
- Exelixis to Release Third Quarter 2026 Financial Results on Thursday, October 29, 2026 – Company Announcement - FT.com — Financial Times
- Exelixis: Q3 Earnings Snapshot | wusa9.com — Associated Press
