Hyperion says EMA to review of marketing authorization application for RAVICTI Hyperion Therapeutics announced that the European Medicines Agency has completed technical and content validation and accepted the filing of the Marketing Authorisation Application for RAVICTI Oral Liquid for the treatment of urea cycle disorders. Acceptance of the MAA confirms that the submission is complete so as to permit a substantive review by the Rapporteurs and the Committee for Medicinal Products for Human Use. "We are very pleased to receive MAA acceptance for review of RAVICTI and anticipate a CHMP opinion in the third quarter of 2015," said Hyperion CEO Donald Santel.
Hyperion Therapeutics price target lowered to $32 from $38 at Cantor Cantor cut its price target on Hyperion after the company reported stronger than expected Q3 results but said distributors would work down 10-12 days of inventory in Q4. The company also said that it would spend $7M-$10M on terminating its DiaPep277 program, noted the firm, which keeps a Buy rating on Hyperion.