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March 18, 2014
07:19 EDTALPMY, MDVNMedivation, 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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December 15, 2014
08:46 EDTMDVNMedivation price target raised to $128 from $107 at Leerink
Leerink raised its price target for Medivation shares to $128 after the company presented Stage 1 and preliminary Stage 2 data from the Phase II trial of Xtandi in advanced androgen receptor positive triple negative breast cancer. The firm believes the data demonstrate "clear single agent activity with confirmed objective responses" and keeps an Outperform rating on the stock.
December 12, 2014
18:05 EDTMDVNMedivation, Astellas Pharma report data from Phase 2 study of enzalutamide
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December 9, 2014
08:48 EDTMDVNMedivation management to meet with Leerink
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07:44 EDTMDVNAmerican Association for Cancer Research to hold a symposium
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