Login to Your Account

Bulls Proved Right as Hyperion’s Ravicti Wins Approval

The recent spike in Hyperion Therapeutics Inc.’s stock proved to be warranted Friday, when the FDA issued an approval for Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders in patients, ages 2 and older. The drug was reviewed under the agency’s fast track program, though its review date was pushed back by three months in September, and in mid-January, the FDA warned of another delay while it ironed out label and postmarketing requirements. Ravicti has orphan status and its approval was based largely on data from a 44-patient trial.