Exelixis, Inc. (NASDAQ:EXEL) announced that the U.S. Food & Drug Administration (FDA) has determined the company’s New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, orFebruary 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016.
“With FDA granting Priority Review to our application, Exelixis is one step closer to offering physicians cabozantinib as an important new therapeutic option for their patients with advanced renal cell carcinoma,” said Michael M. Morrissey, Ph.D., president and CEO of Exelixis. “While we work closely with the FDA during the review process, Exelixis will continue to execute on our commercial plans, including our commitment to be ready for a potential launch by April 1st of this year.”
A Priority Review designation is granted by the FDA for drugs that, if approved, would be significant improvements in the treatment, prevention or diagnosis of a disease. Previously, the FDA granted cabozantinib Breakthrough Therapy designation (August 2015) and Fast Track designation (April 2015) for the compound’s proposed RCC indication.
The NDA is based on the results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress inSeptember 2015 and concurrently published in The New England Journal of Medicine.
On January 11, 2016, Exelixis announced the submission of a Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy to the European Medicines Agency (EMA). The EMA’sCommittee for Medicinal Products for Human Use (CHMP) previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, the company’s MAA will be eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by CHMP).
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. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway,Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of the NDA for advanced RCC. (Original Source)
Shares of Exelixis are up nearly 5% to $4.51 in pre-market trading. EXEL has a 1-year high of $6.81 and a 1-year low of $1.80. The stock’s 50-day moving average is $4.91 and its 200-day moving average is $5.52.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on January 19, Leerink Swann analyst Michael Schmidt upgraded EXEL to Buy, with a price target of $7, which implies an upside of 62.8% from current levels. Separately, on January 13, William Blair’s John Sonnier reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and John Sonnier have a total average return of -1.1% and 5.4% respectively. Schmidt has a success rate of 46.5% and is ranked #2281 out of 3596 analysts, while Sonnier has a success rate of 48.1% and is ranked #640.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.