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 January 21, 2016 and June 27, 2016, 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 Overstating Its Drug's Commercial Viability

According to the complaint, Regulus initiated a Phase 2 study investigating RG-101 in August 2015. Regulus subsequently touted in several public statements that RG-101 was generally well-tolerated with the majority of adverse events considered mild or moderate. On February 17, 2016, Regulus officials announced that RG-101 showed a 97% response, stating, "Based on the results announced today, Regulus intends to accelerate development of RG-101 given its promising potential to shorten treatment regimens." However, the complaint alleges that Regulus officials failed to disclose that patients treated with RG-101 were at an increased risk of contracting jaundice and consequently, the company had overstated RG-101's approval prospects and commercial viability.

On April 15, 2016, Bloomberg reported that Regulus presented interim data from Phase 2 studies for RG-101 that addressed serious adverse effects for RG-101, including jaundice, fatigue, abdominal pain, and nausea, among other things. On May 3, 2016, Regulus reported disappointing financial and operating results for the first quarter of 2016, including a net loss of $21.21 million on revenue of $490,000, compared to a net loss of $14.49 million on revenue of $4.2 million for the same period in the prior year. On June 27, 2016, Regulus announced that it had received verbal notice from the U.S. Food and Drug Administration that it had placed RG-101 on clinical hold after a second serious adverse event of jaundice was reported in a patient treated with the drug. On this news, Regulus's stock fell $2.47 per share, or approximately 49%, to close at $2.54 per share on June 28, 2016.

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.