Repligen Corp (RGEN)

[surf1944]

7:01AM Repligen receives complete response letter from FDA for RG1068 NDA; says 'additional clinical efficacy and safety trial data will be required to support potential approval of the NDA' (RGEN) 4.37 : Co announced that it has received a Complete Response Letter (CRL) from the FDA regarding the co's New Drug Application (NDA) for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with known or suspected pancreatitis. The CRL indicates that the FDA has completed its review of the RG1068 NDA and has determined that additional clinical efficacy and safety trial data will be required to support potential approval of the NDA. There were no specific safety concerns cited in the CRL, although safety will continue to be monitored in conjunction with any future clinical trial. No deficiencies were cited in the CRL with respect to the manufacturing, pharmacology or toxicology sections of the NDA. "We will continue to engage in dialogue with the FDA to determine the design and scope of a clinical program that will address the agency's requirements for approval of RG1068," said Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen. "We believe that RG1068, if approved, will provide a safe and effective means to non-invasively image the pancreas with MRI and will meet an important unmet medical need for patients with pancreatitis."