Company Update (NASDAQ:MDVN): FDA Accepts for Review Medivation Inc and Astellas Pharma’s Supplemental New Drug Application for XTANDI(R) Capsules

Medivation Inc (NASDAQ:MDVN) and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.

A Type-II variation to update the Summary of Product Characteristics (SmPC) has also been submitted to the European Medicines Agency. (Original Source)

Shares of Medivation closed today at $32.36, down $0.40 or -1.22%. MDVN has a 1-year high of $70.79 and a 1-year low of $26.41. The stock’s 50-day moving average is $35.13 and its 200-day moving average is $42.23.

On the ratings front, Medivation has been the subject of a number of recent research reports. In a report issued on February 5, Leerink Swann analyst Howard Liang assigned a Hold rating on MDVN. Separately, on February 2, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $47.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Howard Liang and Jason Kolbert have a total average return of 19.9% and -20.2% respectively. Liang has a success rate of 55.6% and is ranked #108 out of 3637 analysts, while Kolbert has a success rate of 25.9% and is ranked #3634.

The street is mostly Bullish on MDVN stock. Out of 7 analysts who cover the stock, 5 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $52.00, which implies an upside of 57.0% from current levels.

Medivation Inc is a biopharmaceutical company engaged in the development of novel small molecule drugs to treat diseases like Alzheimer’s disease and Huntington disease.


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