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Hyperion soars, despite expected FDA PDUFA miss for Ravicti

This article was originally published in Scrip

Executive Summary

Hyperion Therapeutics revealed on 16 January that the US FDA expected to miss the 23 January Prescription Drug User Fee Act (PDUFA) action date for the company's new drug application for Ravicti (glycerol phenylbutyrate), which is under investigation to treat urea cycle disorders – news that first had panicked investors pushing the shares down 16% in premarket trading, only to do a 360 later in the day, with the stock soaring as high as 21%.


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