Supernus receives FDA fast track designation for SPN-810 Supernus Pharmaceuticals announced that the United States Food and Drug Administration has granted fast track designation for SPN-810 for the treatment of impulsive aggression in attention deficit hyperactivity disorder. This product candidate is expected to enter Phase III testing, with patient dosing commencing during 2015.
Supernus raises FY14 revenue view to $115M-$118M from $105M FY14 consensus $104.44M. The company is reducing its cash burn guidance for the year from $5M-10M to approximately $5M, and raising its guidance for year end cash and marketable securities to approximately $85M. The company anticipates achieving cash flow break even by year end and being profitable in 2015.