Robbins LLP: Regulus Therapeutics Inc. (RGLS) Misled Shareholders According to a Recently Filed Class Action

Robbins LLP announces that a class action complaint was filed against Regulus Therapeutics Inc. (NASDAQGM: RGLS) in the U.S. District Court for the Southern District of California. The complaint is brought on behalf of all purchasers of Regulus securities between February 17, 2016 and January 27, 2017, for alleged violations of the Securities Exchange Act of 1934 by Regulus's officers and directors. Regulus, a biopharmaceutical company, focuses on the discovery and development of drugs that target microRNAs to treat a range of diseases in the United States. One of the company's main clinical development products is known as RG-101 which is designed to treat patients with hepatitis C virus infection.

Regulus Accused of Misleading Investors About the Safety of Its Drug

According to the complaint, Regulus initiated a Phase II study investigating RG-101 in August 2015. On February 17, 2016, Regulus announced in its Form 8-K filed with the U.S. Securities and Exchange Commission that RG-101 was generally well-tolerated with the majority of adverse events considered mild or moderate. On February 22, 2016, Regulus announced in a press release that its priorities for the upcoming year are to accelerate its clinical programs, advance its pipeline, and define the regulatory path to approval for its lead programs. The company subsequently stated that it was encouraged by the consistent trend in efficacy and safety of RG-101 and that the drug was expected to become a "backbone agent in combination with all classes of oral therapies." However, the complaint alleges that Regulus officials failed to disclose that RG-101 was not safe and well tolerated by all patients in the ongoing studies, that cases of serious adverse events ("SAEs") were discovered, and that Regulus would likely need to produce extensive data to the U.S. Food and Drug Administration ("FDA") to continue trials of RG-101.

On April 15, 2016, the company hosted a webcast and conference call to present additional interim data on RG-101 at the International Liver Conference, during which it disclosed in a footnote that the Daklinza arm of the RG-101 Phase II trial had an SAE from jaundice. On June 27, 2016, Regulus announced that it had received verbal notice from the FDA that its Investigational New Drug Application for RG-101 had been placed on full clinical hold after a second SAE of jaundice was reported in a patient treated with the drug. On January 27, 2017, Regulus announced that there can be "no assurances as to when the clinical hold on RG-101 may be lifted, if at all." On this news, Regulus's stock fell $2.25 per share, or approximately 53.3%, to close at $1.30 per share on January 30, 2017.

Regulus Shareholders Have Legal Options

Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.