Exelixis Inc. (NASDAQ: EXEL) kicked off the week with a couple updates that are already having a big impact on the stock. As we know, the FDA can make or break companies, and in this case Exelixis caught a nice tailwind.
The company, with its European partner, Ipsen, 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 company plans to file a supplemental New Drug Application (sNDA) with the FDA in Q1 2018.
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 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", said Gisela Schwab, M.D., president, product development and medical affairs and chief medical officer, Exelixis.
The drugmaker's shares were trading at $29.45 before the bell on Monday.