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News Breaks
April 9, 2013
16:06 EDTEXELExelixis announces presentation of data for its compound cabozantinib
Exelixis announced the presentation of preclinical data that provide insight into the mechanism of action of its lead compound, cabozantinib, with respect to its activity against prostate cancer tumors that have metastasized to the bone. Previously reported clinical findings with cabozantinib in castration-resistant prostate cancer patients with bone metastases have included a 67% rate of bone scan response, reduced 99Tc-MDP uptake, and reductions in plasma markers of osteoclast activity. In the poster presented today, the investigators reported on a refined prostate cancer bone metastasis model that develops many of the features associated with bone metastases in CRPC patients. "In this preclinical study, we investigated cabozantinib’s activity in an animal model of prostate cancer bone metastasis with many of the same features associated with bone metastases in CRPC patients,” said Dr. Simon Robinson, the senior author of the study. “Treatment with cabozantinib resulted in tumor cell death, increases in ADC, and normalization of bone architecture, which was accompanied by reduced uptake of 99Tc-MDP. These results suggest the compound’s effect upon bone metastases is significant and comprised of multiple mechanisms.”
News For EXEL From The Last 14 Days
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February 1, 2016
08:07 EDTEXELExelixis announces positive overall survival results from Meteor trial
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January 28, 2016
16:17 EDTEXELExelixis announces EMA acceptance of MAA for cabozantinib
Exelixis announced the European Medicines Agency, or EMA, has accepted for review the Marketing Authorization Application, or MAA, for cabozantinib as a treatment for patients with advanced renal cell carcinoma, or RCC, who have received one prior therapy. The completion of the MAA validation process confirms that 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, or CHMP, previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, the MAA will be eligible for a 150-day review, versus the standard 210 days.
09:19 EDTEXELOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Facebook (FB), up 13.9%... Under Armour (UA), up 14.6%... MicroStrategy (MSTR), up 8.9%... Harley-Davidson (HOG), up 8%... Paypal (PYPL), up 6%... Mellanox (MLNX), up 7.9%... Cirrus Logic (CRUS), up 6.2%... Alibaba (BABA), up 4.5%. ALSO HIGHER: Neos Therapeutics (NEOS), up 61.4% after the FDA approved Adzenys XR-ODT for the treatment of ADHD... Exelixis (EXEL), up 4.7% after the U.S. FDA determined the company's New Drug Application for cabozantinib is sufficiently complete... Kinder Morgan (KMI), up 6.7% after being upgraded at Credit Suisse and Stifel. DOWN AFTER EARNINGS: OSI Systems (OSIS), down 21.3%... ServiceNow (NOW), down 22.3%... eBay (EBAY), down 11.5%... InvenSense (INVN), down 10.5%... Juniper Networks (JNPR), down 9.3%... Hologic (HOLX), down 4.4%... Abbott Laboratories (ABT), down 3.6%... Potash (POT), down 2.1%... Qualcomm (QCOM), down 3.6%.
08:03 EDTEXELExelixis: FDA deems NDA for cabozantinib as 'sufficiently complete'
Exelixis announced that the U.S. FDA has determined the company's New Drug Application for cabozantinib as a treatment for patients with advanced renal cell carcinoma 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, or February 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 and Fast Track designation 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 in September 2015 and concurrently published in The New England Journal of Medicine.

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