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Regulus’ shares drop as FDA puts trials for hepatitis C drug on hold

pharmafile | June 29, 2016 | News story | Research and Development, Sales and Marketing |  Regulus Therapeutics, US FDA, drug trial, hepatitis C virus, regulation 

Shares in Regulus Therapeutics (Nasdaq: RGLS) plunged as much as 60% after the company said the US Food and Drug Administration (FDA) has put on hold trials for its drug compound to treat chronic hepatitis C virus.

The company said the regulator initiated the clinical hold following the report of a second serious adverse event of jaundice in a patient with end-stage renal disease on dialysis enrolled in an ongoing Phase I study of RG-101.

The adverse event occurred 117 days after receiving a single dose of RG-101, the company said.

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Regulus said the timelines for three ongoing studies of RG-101 are not expected to be impacted as all patients have completed their dosing.

About 130–150 million people in the world have chronic hepatitis C infection, a liver disease that can cause liver cirrhosis or liver cancer, according to statistics.

Anjali Shukla

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