Exelixis, Inc. (NASDAQ:EXEL) announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Cabozantinib is the company’s lead compound and inhibits the activity of multiple tyrosine kinases including MET, VEGFRs and RET. The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious diseases and address unmet medical needs. Fast Track designation confers important benefits, including the potential eligibility for Priority Review of a New Drug Application, if relevant criteria are met.1
Cabozantinib is the subject of METEOR, an ongoing phase 3 pivotal trial in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor. Patients are randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily. The primary endpoint of METEOR is progression-free survival, and secondary endpoints include overall survival and objective response rate. Exelixis expects to release top-line results from the trial in the second quarter of 2015. In addition to the metastatic RCC development program, Exelixis is also evaluating cabozantinib in CELESTIAL, a phase 3 pivotal trial in second-line hepatocellular carcinoma (HCC). (Original Source)
Shares of Exelixis closed yesterday at $2.85 . EXEL has a 1-year high of $4.55 and a 1-year low of $1.26. The stock’s 50-day moving average is $2.80 and it’s 200-day moving average is $1.94.
On the ratings front, Cowen analyst Eric Schmidt reiterated a Hold rating on EXEL, In a report issued on February 26.
According to TipRanks.com, Schmidt has a total average return of 49.8%, an 80.9% success rate, and is ranked #24 out of 3571 analysts.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.