(Reuters) - Repligen Corp said U.S. health regulators denied approval for its imaging agent to detect structural abnormalities in the pancreas, sending its shares down 10 percent.
The U.S. Food and Drug Administration has asked for additional efficacy and safety trial data to approve the agent, called RG1068, in a complete response letter.
Repligen said in April that it did not expect the FDA to approve the imaging agent as the regulator had canceled an advisory committee meeting to review the agent.
In the complete response letter, the regulator did not cite any deficiency with respect to the manufacturing, pharmacology or toxicology sections of the approval application.
The company's shares, which dropped 40 percent on April 26 when the company said it was expecting a rejection, were down 9 percent at $3.99 in morning trade on the Nasdaq. They touched a low of $3.95 earlier in the session.
(Reporting by Prateek Kumar and Esha Dey in Bangalore; )