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News Breaks
March 18, 2014
07:19 EDTMDVN, ALPMYMedivation, Astellas Pharma submit sNDA for XTANDI
Astellas Pharma (ALPMY) and Medivation (MDVN) announced the submission of a supplemental New Drug Application, or sNDA, to the FDA seeking approval of XTANDI capsules for the treatment of men with metastatic castration-resistant prostate cancer, or mCRPC, who have not received chemotherapy. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy. The sNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-na´ve mCRPC patients. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year.
News For MDVN;ALPMY 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 XTANDI« 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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