Repligen Announces FDA Grant of Priority Review for SecreFlo NDA

Repligen Corporation RGEN announced today that the U.S. Food and Drug Administration has accepted for filing and granted Priority Review to the Company's new drug application for SecreFlo™ for the improved detection of pancreatic duct abnormalities in patients with pancreatitis. Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review. The FDA has assigned a PDUFA goal date of June 21, 2012 to the SecreFlo™ NDA.