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. 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 tri
Timelines of On-going Studies are not Expected to be Impacted Conference Call Today at 5:00 p.m. ET LA JOLLA, Calif., June 27, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced it received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) for RG-101 for the t
-Oral presentation during general session on interim RG-101 Phase II results & three posters to be presented-LA JOLLA, Calif., March 16, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that new data on RG-101, the company's anti-miR-122 in Phase II development for the treatment of Hepatitis C Virus infection (HCV...
Regulus Therapeutics Inc said interim mid-stage data for its hepatitis C combination drug showed it had the potential to sharply reduce the duration of the treatment to four weeks from 12 weeks.The company's shares recorded their best day in more than 15 months, rising as much as 41 percent to $8.85 in heavy trading on Wednesday.Regulus tested its injectable drug, RG-101, separately with FDA-approved hepatitis C drugs such as Gilead Sciences Inc's Harvoni,