Exelixis, Inc. (NASDAQ:EXEL) announced that the European Commission (EC) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. CABOMETYX was granted accelerated assessment by the European Medicines Agency, and is the first therapy to demonstrate in a phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival (OS), progression-free survival (PFS) and objective response rate (ORR). This approval allows for the marketing of CABOMETYX in all 28 member states of the European Union, Norway and Iceland.

EC approval of CABOMETYX triggers a $60 million milestone payment to Exelixis under the licensing agreement with Ipsen for the commercialization and further development of CABOMETYX indications outside of the United States, Canada and Japan. The approval is based on the results of the large, randomized phase 3 METEOR trial.

“The marketing authorization of CABOMETYX by the European Commission to treat patients with advanced renal cell carcinoma reflects the strong efficacy results observed with cabozantinib in the phase 3 METEOR trial, and is an important milestone in our collaboration with Ipsen,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “This marketing authorization helps address an unmet medical need in Europe by providing patients with a new therapy that slows disease progression and prolongs overall survival. We look forward to further examining the use of CABOMETYX in earlier lines of therapy and in other difficult-to-treat cancers.” (Original Source)

Shares of Exelixis are up nearly 5% to $12.89 in pre-market trading. EXEL has a 1-year high of $12.48 and a 1-year low of $3.55. The stock’s 50-day moving average is $10.75 and its 200-day moving average is $6.99.

On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on September 7, Leerink Swann analyst Michael Schmidt maintained a Buy rating on EXEL, with a price target of $12, which represents a slight downside potential from current levels. Separately, on August 4, Stifel Nicolaus’ Stephen Willey maintained a Buy rating on the stock and has a price target of $12.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and Stephen Willey have a total average return of 15.2% and 19.8% respectively. Schmidt has a success rate of 61% and is ranked #130 out of 4163 analysts, while Willey has a success rate of 54.5% and is ranked #121.

Exelixis, Inc. is a biopharmaceutical company, which engages in the developing and commercializing small molecule therapies for the treatment of cancer. Its brands include COMETRIQ and cobimetinib. The company focuses on their proprietary resources and development and commercialization of cabozantinib.