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June 1, 2014
17:03 EDTALPMY, MDVNNew 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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September 11, 2014
07:50 EDTMDVNPotential of Medivation Xtandi underappreciated, says Bernstein
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07:37 EDTMDVNMedivation to host conference call
Conference call to discuss FDA approval of XTANDIŽ to be held on September 11 at 8:30 am. Webcast Link
07:11 EDTMDVNMedivation price target raised to $112 from $89 at Stifel
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September 10, 2014
16:41 EDTMDVNMedivation to resume trading at 4:50 pm ET
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16:26 EDTMDVNMedivation receives $90M milestone payment after FDA approves XTANDI indication
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15:16 EDTMDVNMedivation Xtandi efficacy supplement posted to FDA website
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14:48 EDTMDVNMedivation trading halted, pending news
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September 9, 2014
10:10 EDTMDVNOn the Fly: Analyst Upgrade Summary
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08:42 EDTMDVNMedivation upgraded at Bernstein
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06:43 EDTMDVNMedivation upgraded to Outperform from Market Perform at Bernstein
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September 7, 2014
17:30 EDTALPMYFDA accepts Astellas filing of isavuconazole NDA
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