Regulus Therapeutics Inc. (RGLS) said the U.S. Food and Drug Administration (FDA) is maintaining a clinical hold on its hepatitis C drug candidate, RG-101. The drug was placed on clinical hold in June 2016, when a second case of jaundice was reported during clinical trials. The FDA update tanked Regulus’ stock price by more than 40% on Monday, when it closed at $1.30 per share, down sharply from Friday’s close of $2.25.
FDA Requests More Data
Although Regulus submitted a response following the clinical hold last summer, the FDA has requested final safety and efficacy data from an ongoing clinical trial. However, Regulus will have to wait until the fourth quarter to present the data, as it won’t be available until after 48 weeks of follow-up have been completed on the drug study.
RG-101 was hailed as a potential hepatitis C blockbuster drug two years ago. The drug works by targeting a particular microRNA in the liver, which aids the replication and translation of the hepatitis C virus in the liver. When used in combination with other therapies, it is believed to shorten the treatment time for hepatitis C