Exelixis, Inc. (NASDAQ:EXEL) announced that it has submitted a Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy to the European Medicines Agency (EMA). The EMA will now conduct its standard validation process to determine whether the submission is sufficient to permit a substantive review for marketing authorization in the European Union.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, if validated, the MAA may be eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by CHMP).
“The regulatory submission in the European Union follows our recent U.S. filing, and is an integral component of our plan to bring an important new treatment option for advanced kidney cancer to patients in need,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “As we seek to maximize the opportunity for the cabozantinib franchise on a worldwide basis, our discussions with potential partners for territories outside of the United States continue to advance. At the same time, we are making significant progress on our commercial readiness to market cabozantinib for advanced RCC in the United States, if approved.”
The MAA is based on 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 from METEOR 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 in September 2015 and concurrently published in The New England Journal of Medicine.
In the United States, on December 23, 2015, Exelixis announced that it completed the submission of its rolling New Drug Application for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy; the U.S. Food and Drug Administration is currently conducting its preliminary review of the application’s suitability for full review and has not yet assigned a potential Prescription Drug User Fee Act date. The FDA previously granted Breakthrough Therapy and Fast Track designations to cabozantinib for its potential advanced RCC indication; in its NDA,Exelixis has requested Priority Review designation.
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 MAA for advanced RCC. (Original Source)
Shares of Exelixis closed last Friday at $4.895, down $0.04 or -0.71%. EXEL has a 1-year high of $6.81 and a 1-year low of $1.60. The stock’s 50-day moving average is $5.27 and its 200-day moving average is $5.45.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on January 5, Leerink Swann analyst Michael Schmidt reiterated a Hold rating on EXEL, with a price target of $6, which implies an upside of 22.6% from current levels. Separately, on September 28, Cowen’s Eric Schmidt 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 Eric Schmidt have a total average return of 6.1% and 22.3% respectively. Schmidt has a success rate of 47.5% and is ranked #703 out of 3610 analysts, while Schmidt has a success rate of 41.5% and is ranked #96.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.