Repligen Corp. (RGEN) has fallen in pre-market trading on Friday, pulled down by news that the FDA has requested more clinical data to approve its experimental pancreatitis treatment. Shares are down $0.88, or 20%, before the opening bell.
The company said it got a Complete Response Letter, or CRL, from the FDA regarding the company's New Drug Application for RG1068 (synthetic human secretin).
RG1068 was assessed 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.
For comments and feedback contact: editorial@rttnews.com
Business News
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.