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Repligen Says FDA May Seek More Data on Imaging Drug

Repligen Corp. (RGEN), a biotechnology company developing treatments for rare conditions, said it expects the U.S. Food and Drug Administration to ask for more information about its pancreatic imaging treatment. The shares plunged the most in eight years.

The FDA, which was scheduled to decide whether to approve the drug by June 21, canceled a May meeting of advisers to review the compound, RG1068, Repligen said in a statement today. The Waltham, Massachusetts-based company anticipates regulators will ask for additional clinical trial information.

“While we are disappointed in this result, we continue to believe that RG1068 is a safe and effective agent for imaging of the pancreatic ducts, and that it has the potential to meet a significant unmet patient need,” Walter Herlihy, president and chief executive officer of Repligen, said in the statement.

Repligen fell 40 percent to $4.34 at the close of trading, the most since January 2004. The shares had more than doubled this year through yesterday.

The FDA notified the company midday yesterday about the meeting cancellation. Repligen plans to work with the agency to assess a potential path forward, Herlihy said.

The experimental drug is a synthetic version of human secretin that improved detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis during a final-phase study, according to Repligen.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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