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Shares of
Exelixis, Inc.EXEL were surging higher by more than 35 percent during Monday's pre-market trading session after the company
announced positive top-line results from METEOR in which the study met the primary endpoint of significantly improving progress-free survival.
Exelixis's positive top-line results stem from a phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).
The trial met its primary endpoint of showing a statistically significant increase in progress-free survival in the first 375 randomized patients. Detailed results of the trial will be presented at an upcoming medical conference.
Cabozantinib has already received a Fast Track designation by the U.S. Food and Drug Administration FDA) while Exlixis plants to complete regulatory filings in the U.S. and European Union in early 2016 following the successful outcome of its study.
"The positive top-line results from METEOR represent strong progress for the kidney cancer community and for Exelixis, bringing us one step closer to our shared goal of delivering a new and meaningfully differentiated therapeutic option for the many metastatic RCC patients in need," said Michael M. Morrissey, Ph.D., the company's president and chief executive officer.
Exelixis will host a conference call to further discuss the results on July 20. The presentation is scheduled to begin at 8:30 AM. An archived replay will be available on the company's investors and media section of its website
for at least 30 days.
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