Thursday, April 26, 2012

Reuters: Regulatory News: UPDATE 1-Repligen expects FDA to reject its imaging agent

Reuters: Regulatory News
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UPDATE 1-Repligen expects FDA to reject its imaging agent
Apr 26th 2012, 14:38

April 26 | Thu Apr 26, 2012 10:38am EDT

April 26 (Reuters) - Repligen Corp said it expects U.S. health regulators to reject its imaging agent used in MRI scans to detect pancreatic disease, sending its shares down as much as 45 percent.

Repligen, which supplies biologic products used in manufacturing drugs, said the U.S. Food and Drug Administration notified the company about its decision to cancel the scheduled advisory committee meeting on May 31.

The company said it expects the FDA to reject its marketing application on June 21, requesting additional clinical trial data.

Repligen's stock was down 36 percent at $4.66 on Thursday, making it the top percentage loser on the Nasdaq.

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