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News Breaks
June 1, 2014
17:03 EDTMDVN, ALPMYNew England Journal of Medicine publishes results from Phase 3 PREVAIL trial
Astellas Pharma US , a U.S. subsidiary of Tokyo-based Astellas Pharma (ALPMY) and Medivation (MDVN) announced the online publication in the New England Journal of Medicine of the results from the Phase 3 PREVAIL trial, an international, randomized, double-blind, placebo-controlled clinical study of enzalutamide. The study evaluated the benefit and safety of enzalutamide in men with metastatic prostate cancer, who had few or no symptoms, that had progressed on luteinizing hormone-releasing hormone, LHRH, therapy or after bilateral orchiectomy. The paper, "Enzalutamide in Men with Metastatic Prostate Cancer Before Chemotherapy," appears in the June 1 online issue and the companies anticipate publication in a future print issue of the Journal. "The PREVAIL study results demonstrate that treatment with enzalutamide in men with metastatic castration resistant prostate cancer can decrease the risk of death, delay the growth or spread of metastatic prostate cancer, and delay the time to initiation of chemotherapy," said Tomasz M. Beer, M.D., F.A.C.P., professor of medicine and deputy director of the Knight Cancer Institute at Oregon Health & Science University, and co-principal investigator of the PREVAIL study. "We are delighted that the New England Journal of Medicine has chosen to publish these important results." A supplemental New Drug Application, sNDA, based on the PREVAIL results received a priority review designation from the U.S. Food and Drug Administration. The Prescription Drug User Fee Act, PDUFA, goal date is September 18. A variation application to amend the European Marketing Authorization Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24.
News For ALPMY;MDVN From The Last 14 Days
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February 26, 2015
05:39 EDTALPMYCytokinetics announces publication of preclinical data relating to CK-2127107
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February 25, 2015
16:21 EDTMDVNMedivation reports Q4 EPS $1.96, consensus $1.34
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15:05 EDTMDVNNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include salesforce.com (CRM), consensus 14c... Avago Technologies (AVGO), consensus $1.94... L Brands (LB), consensus $1.80... Workday (WDAY), consensus (6c)... BioMarin (BMRN), consensus (59c)... Concho Resources (CXO), consensus 84c... Antero Resources (AR), consensus 28c... Medivation (MDVN), consensus $1.34... Transocean (RIG), consensus 77c... Sprouts Farmers Market (SFM), consensus 9c... SINA Corporation (SINA), consensus 18c.
February 23, 2015
06:25 EDTMDVNMedivation removed from Focus List at Citigroup
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06:23 EDTMDVNCiti ups TESARO price target to $79, adds to focus list
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