Exelixis, Inc. (NASDAQ:EXEL) announced the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to cabozantinib, Exelixis’ lead compound, as a potential treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Created in 2012, FDA’s Breakthrough Therapy Designation expedites the development and review of drugs that are intended to treat serious or life-threatening diseases, and for which preliminary clinical evidence indicates the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Drugs that receive Breakthrough Therapy Designation may benefit from involvement of FDA senior managers in the review process, potential rolling submission and/or Priority Review of a sponsor’s New Drug Application (NDA), and other benefits.
“Receiving Breakthrough Therapy Designation is an important regulatory achievement for cabozantinib in renal cell carcinoma,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Following the positive top-line results announced in July and a productive dialogue with the FDA, Exelixis believes we can expedite our regulatory timelines and complete the cabozantinib NDA submission in advanced RCC prior to the end of 2015. We look forward to working closely with the FDA during the submission and review process, keeping in mind our ultimate goal of bringing a new therapeutic option to the renal cell carcinoma community as soon as possible.”
Cabozantinib received Breakthrough Therapy Designation based on the results of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in patients with RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). In top-line results announced in July 2015, METEOR met its primary endpoint, demonstrating a statistically significant increase in progression-free survival (PFS) for cabozantinib as compared to everolimus in the first 375 patients randomized as determined by an independent radiology review committee. Cabozantinib reduced the rate of disease progression or death by 42 percent compared to everolimus (hazard ratio [HR]=0.58, 95 percent confidence interval [CI] 0.45-0.75, p<0.0001).
Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ®in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. A distinct tablet formulation of cabozantinib is under investigation for advanced renal cell carcinoma and other types of cancer. COMETRIQ is not indicated for patients with advanced RCC or any other form of the disease. (Original Source)
Shares of Exelixis closed last Friday at $5.25. EXEL has a 1-year high of $6.81 and a 1-year low of $1.26. The stock’s 50-day moving average is $5.20 and its 200-day moving average is $3.59.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on July 20, Cowen analyst Eric Schmidt upgraded EXEL to Buy. Separately, on the same day, Piper Jaffray’s Edward Tenthoff maintained a Hold rating on the stock and has a price target of $6.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Schmidt and Edward Tenthoff have a total average return of 35.0% and 16.3% respectively. Schmidt has a success rate of 55.6% and is ranked #44 out of 3737 analysts, while Tenthoff has a success rate of 48.2% and is ranked #344.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.