Repligen Concludes Pre-NDA Meeting with FDA for RG1068

Repligen Corporation RGEN today announced that the Company has concluded a pre-New Drug Application meeting with the U.S. Food and Drug Administration related to its lead product candidate, RG1068 for improvement of magnetic resonance imaging of the pancreas. The purpose of the meeting was to discuss the positive results of the “re-read” of the radiographic images from the Company's Phase 3 clinical trial and to reach agreement on the content and format of the proposed NDA for RG1068. Based on this meeting, we intend to submit our NDA as previously planned. “The conclusion of this meeting brings us closer to our objective to obtain FDA approval and commercialize RG1068 in the U.S. to improve pancreatic imaging,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. “RG1068 has been granted Fast Track Designation, and we intend to request that the FDA grant our application priority review when we file our NDA later this summer.”