Exelixis, Inc. (NASDAQ:EXEL) is a mover and shaker out on the Street today, with investors sparking the stock on an almost 30% upturn. The reason? The drug maker announced that the FDA has accepted Cabometyx’s sNDA filing based on positive CABOSUN data in first line intermediate- and high-risk RCC. The filing was granted priority review with a February 15, 2018 PDUFA date.
Gisela Schwab, President, Product Development and Medical Affairs and Chief Medical Officer of 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.”
Separately, Exelixis announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis.
“We are excited that these positive results from the phase 3 CELESTIAL trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option […] This is an important milestone for the cabozantinib development program; we are committed to studying cabozantinib in a range of tumor types as part of our mission to deliver medicines that improve treatment outcomes and give patients hope for the future,” Schwab said.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on October 4, Oppenheimer analyst Leah R. Cann assigned a Hold rating on EXEL. On the other hand, on September 22, Suntrust Robinson Humphrey’s Peter Lawson maintained a Buy rating on the stock and has a price target of $33.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Leah R. Cann and Peter Lawson have a yearly average return of 23.8% and 18.5% respectively. Cann has a success rate of 81% and is ranked #190 out of 4697 analysts, while Lawson has a success rate of 55% and is ranked #259.
Overall, 3 research analysts have assigned a Hold rating and 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $30.43 which is 22.9% above where the stock closed on Friday.
Exelixis is a biopharmaceutical company. It engages in the developing and commercializing small molecule therapies for the treatment of cancer. The company brands include comertriq and cobimetinib. Its pipeline consists of cabozantinib, cobimetinib and Xl 888.