The bulls are sharpening their horns in sweet anticipation of Vanda Pharmaceuticals' (VNDA) upcoming Advisory Committee Meeting with the FDA for tasimelteon's New Drug Application (NDA). Tasimelteon is a circadian regulator in development as an indication for Non-24Hr disorder in the totally blind.
Last December, Vanda reported positive Phase III data for tasimelteon, causing the stock to surge 166% year-to-date. Adding fuel to the fire, the FDA recently agreed to bestow upon tasimelteon a highly coveted "Priority Review". The drug is thus set for an Advisory Committee hullabaloo on November 14th, with a target PDUFA date of January 31, 2014. With peak sales projected to top $500 M per year for a company with a sub $300...
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