• US stock market daily report (July 20, 2015, Monday)

    Biopharmaceutical company Exelixis, Inc. (EXEL-Nasdaq) shares soared higher by nearly 50% during pre-market trading session on Monday after reporting positive results in a late-stage trial of a kidney cancer drug Cabozantinib.

    Primary analysis of METEOR, the phase 3 pivotal trial comparing Cabozantinib to everolimus in 658 patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.

    Primary endpoint was met while demonstrating a statistically significant increase in progression-free survival in the first 375 randomized patients as determined by an independent radiology committee. Cabozantinib reduced the risk of disease progression or death by 42% compared to the everolimus arm.

    Toni K. Choueiri, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and METEOR’s principal investigator said, “We are eager to offer new treatment options for patients with metastatic RCC, particularly in the second-line setting where the most commonly utilized therapies have demonstrated a uniformly modest progression-free survival benefit. The magnitude of the improvement in PFS observed with cabozantinib compared to everolimus in the METEOR trial is an exciting and important development — it suggests an opportunity to improve care and outcomes for patients with metastatic RCC.”

    Exelixis said the new drug reduced the risk of disease progression or death by 42% compared to the everolimus arm.

    Exelixis president and chief executive officer Doctor Michael M. Morrissey, Ph.D. said, “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. With these data now in hand, Exelixis’ highest corporate priority becomes the submission of U.S. and EU regulatory filings, which we intend to complete in early 2016.”

    Dr. Morrissey added, “Delivering these top-line results for METEOR is one of multiple clinical development and regulatory milestones that we have planned for this year. These milestones collectively have the potential to significantly enhance the opportunities before us and bring value to the multiple stakeholders we serve. We look forward to sharing the detailed results of METEOR with the oncology community at an upcoming medical conference, and we thank all of the patients, families, investigators, and clinical staff who made the trial possible.”

    Cabozantinib received Fast Track designation by the U.S. Food and Drug Administration for the potential treatment of advanced RCC patients who have received one prior therapy, in April 2015.

    Exelixis plans to complete regulatory filings in the United States and European Union in early 2016, based on the outcome of METEOR.

    According to the American Cancer Society, kidney cancer is one of the top ten most common forms of cancer.

    Contributed by Millennium Traders
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