Repligen falls on potential SecreFlo delay

Repligen Corp. (NASDAQ:RGEN) plummeted $2.92 (40%) to $4.34 on Thursday after saying it expects FDA to issue a complete response letter for SecreFlo to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. The company expects the agency to request additional clinical data, but said it does not know whether the agency will require another Phase III trial. Repligen also said FDA canceled a May 31 meeting of the Gastrointestinal Drugs Advisory Committee to discuss the NDA for SecreFlo. Details were not disclosed. ...