Exelixis, Inc. (EXEL) announced that its New Drug Application for zanzalintinib, in combination with atezolizumab, has been accepted for review in the U.S. for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor therapy. The FDA assigned a standard review with a PDUFA target action date of December 3, 2026. The NDA is based on the results of the phase 3 STELLAR-303 pivotal trial.
"We look forward to collaborating with the FDA during the review process for our first NDA for zanzalintinib," said Dana Aftab, Executive Vice President, Research and Development, Exelixis.
In pre-market trading on NasdaqGS, Exelixis shares are up 0.75 percent to $41.67.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.