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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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.