Biogen receives notification of PDUFA date extension for Plegridy Biogen Idec announced that the U.S. Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for its review of the Biologics License Application for marketing approval of PLEGRIDY, a subcutaneous pegylated interferon candidate for relapsing forms of multiple sclerosis. The PDUFA date has been extended by three months, which is the standard extension period. The FDA has indicated that the extension of the PDUFA date is required to allow additional time for review of the application. The agency has not asked for additional studies.
News For BIIB From The Last 14 Days
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Biogen July weekly volatility elevated into Q2 and outlook Biogen July weekly call option implied volatility is at 55, August is at 34, October is at 36; compared to its 26-week average of 33 according to Track Data, suggesting large near term price movement into the expected release of Q2 on July 23.