Market Overview

Repligen Plummets 40% After FDA Canceled Advisory-Committee Meeting for SecreFlo

Shares of Repligen (NASDAQ: RGEN) are seeing much weakness after the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA.

The Company 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.

“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,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. “We intend to continue our dialogue with the FDA to assess a potential path forward for RG1068.”

Currently, shares of Repligen are trading down about 41% at $4.25 per share.

Posted-In: News FDA Intraday Update Movers

 

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