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.
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