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FDA places Regulus' Hep C drug on clinical hold; shares dive

Tuesday, Jun 28, 2016

Regulus Therapeutics Inc said the U.S. Food and Drug Administration placed on clinical hold the company's drug to treat chronic hepatitis C virus infection, sending its shares plunging 60 percent in extended trading.

The FDA initiated the clinical hold on the drug, RG-101, after Regulus reported a second serious adverse event of jaundice, the company said on Monday.

However, Carlsbad, California-based Regulus said timelines for three on-going studies of RG-101 are not expected to be impacted and that the company remains on track to deliver follow-up results from the studies.]

According to World Health Organization, about 130–150 million people globally have chronic hepatitis C infection, a liver disease that can cause liver cirrhosis or liver cancer.

 

Source : reuters.com

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