Repligen Corp. (RGEN) announced that 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 said it 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).
The company said that it intends to continue its dialogue with the FDA to assess a potential path forward for RG1068.
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 the company 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.
On March 5, 2012 Repligen said it submitted an MAA to the EMA, which has been successfully validated for full review by the EMA's Committee for Medicinal Products for Human Use.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.