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News Breaks
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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March 30, 2015
09:18 EDTMDVNMedivation price target raised to $163 from $126 at Maxim
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08:22 EDTMDVNMedivation price target raised to $163 from $126 at Maxim
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07:24 EDTMDVNStifel to hold a bus tour
BioTrek: 2015 West Coast Healthcare Therapeutics Bus Tour travels throughout San Francisco on March 30-April 1.
March 27, 2015
06:55 EDTMDVNMedivation price target raised to $150 from $133 at Barclays
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March 25, 2015
16:21 EDTALPMYVical in-licenses novel antifungal ASP2397 from Astellas Pharma
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09:06 EDTMDVNMedivation price target raised to $144 from $123 at William Blair
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07:53 EDTMDVNMedivation reported strong, positive results, says JMP Securities
JMP Securities says that the results of a study comparing Medivation's Xtandi to bicalutamide, the market leading prostate cancer medication, were strong and positive for Medivation. The firm continues to expect Xtandi to prove to be superior to bicalutamide. It expects Xtandi to generate $8B in worldwide revenue and raised its price target on Medivation to $143 from $126 while keeping an Outperform rating on the shares.
07:39 EDTMDVNMedivation price target raised to $142 from $125 at Brean Capital
Brean Capital raised its price target on Medivation to $142 from $125 following the presentation of additional Phase 2 TERRAIN trial data in metastatic castration-resistant prostate cancer and final OS data from the Phase 3 PREVAIL trial in chemo-naive mCRPC. The firm remains optimistic by consistent and positive data and reiterated its Buy rating on Medivation shares.
07:02 EDTMDVNMedivation price target raised to $148 from $130 at JPMorgan
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March 24, 2015
07:07 EDTMDVN, ALPMYAstellas Pharma and Medivation report data from Phase 2 Terrain trial
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March 20, 2015
09:06 EDTALPMYAmgen submits application for marketing approval for RepathaTM in Japan
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