FDA Cancels Meeting with Repligen (REGN) for RG1068; Will Get CRL on June 21st

April 26, 2012 9:58 AM EDT
Repligen Corporation (NASDAQ: RGEN) reports that midday yesterday, the FDA notified the Company that the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA. The Company expects to receive a Complete Response letter on the previously announced June 21 PDUFA date requesting additional clinical trial data to support the New Drug Application (NDA).

RG1068 is a synthetic version of human secretin which was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. On December 21, 2011 we filed a NDA, and on February 21, 2012, the FDA accepted the filing of our NDA and granted it priority review based on its prior Orphan Drug and Fast Track designations. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal for completing review of the NDA is June 21, 2012.

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