Medivation, Inc. (MDVN) shares received a major boost recently with the company and its partner, Astellas, reporting impressive data on MDV3100 from a pre-specified interim analysis of a phase III study, AFFIRM. The Independent Data Monitoring Committee (IDMC) recommended that MDV3100's risk-to-benefit ratio was favorable enough to stop the study.
Medivation and Astellas intend to conduct a pre-NDA meeting with the FDA in early 2012. We believe the companies will file for regulatory approval of MDV3100 soon thereafter and expect MDV3100 to hit the market in 2013.
Based on the data that we have seen so far, we believe MDV3100 has blockbuster potential and will be a game-changer for Medivation. We are upgrading Medivation to Outperform based on the improved prospects of the company.
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