Hyperion soars, despite expected FDA PDUFA miss for Ravicti
This article was originally published in Scrip
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%.
You may also be interested in...
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.