Exelixis Inc. (NASDAQ: EXEL) kicked off the week with a couple updates that are already having a big impact on the stock. These updates came in the form of a key U.S. Food and Drug Administration (FDA) approval. As we know, the FDA can make or break companies, and in this case Exelixis caught a nice tailwind.
According to the release, the FDA determined the company’s supplemental New Drug Application (sNDA) for CaboMetyx (cabozantinib) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2018.
The sNDA is based on data from Cabosun, a randomized Phase 2 trial conducted by the Alliance for Clinical Trials in Oncology as part of Exelixis’s collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program.
Gisela Schwab, M.D., president of Product Development and Medical Affairs and chief medical officer, Exelixis, commented:
The acceptance of the sNDA filing with a Priority Review is an important regulatory milestone for CaboMetyx and for our mission to improve treatment outcomes for patients with cancer. We look forward to working with the FDA as they review the application in our effort to offer CaboMetyx to patients with previously untreated metastatic RCC who are in need of new treatment options.
CaboMetyx was previously approved by the FDA on April 25, 2016, for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.
Another potential driver of the stock was a successful late-stage trial for the treatment of liver cancer.
Shares of Exelixis closed Friday at $24.76, with a consensus analyst price target of $29.71 and a 52-week range of $10.04 to $29.50. Following the announcements, the stock was up about 19% at $29.42 in early trading indications Monday.