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February 3, 2014
06:18 EDTMDVNMedivation downgraded to Hold from Buy at Needham
Needham downgraded Medivation citing valuation as it believes near-term market dominance in the pre-chemo prostate cancer space is being priced into shares at current levels.
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October 31, 2014
05:13 EDTMDVNMedivation, Astellas Pharma plan to initiate enzalutamide Phase 3 study
Medivation (MDVN) and Astellas announced plans to initiate a global Phase 3 clinical trial that will evaluate the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred following definitive local therapy with radical prostatectomy and/or radiation therapy. Currently there is no prescription medicine specifically approved in the United States for these patients. The Phase 3 randomized, multi-national trial will be conducted at approximately 160 sites and is designed to enroll approximately 1,860 hormone-sensitive, non-metastatic men with biochemical recurrence following prostatectomy and/or radiation therapy that are at high risk for morbidity and mortality from prostate cancer. Patients will be randomized into three separate groups: enzalutamide plus leuprolide acetate, enzalutamide monotherapy, or placebo plus leuprolide acetate. Treatment with enzalutamide monotherapy will be open-label. Treatment with enzalutamide and placebo will be double-blind in combination with open-label leuprolide acetate. The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily.
October 23, 2014
17:13 EDTMDVNMedivation licenses clinical stage anti-PD-1 modulatory monoclonal antibody
Medivation announced Medivation has licensed exclusive worldwide rights to CureTech's late-stage clinical molecule pidilizumab, an immune modulatory anti-PD-1 monoclonal antibody. Under the license agreement, Medivation will be responsible for all development, regulatory and commercialization activities for pidilizumab for all indications, including oncology. Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5M from Medivation and would also be entitled to payments upon the attainment of certain development and regulatory milestones totaling $85M. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245M, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4%-11% based on annual worldwide net sales.

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