Pomerantz LLP announces that a class action lawsuit has been filed against Regulus Therapeutics Inc. (“Regulus” or the “Company”) and certain of its officers. The class action, filed in United States District Court, Southern District of California, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired Regulus securities between January 21, 2016 and June 27, 2016, both dates inclusive (the “Class Period”), seeking to recover compensable damages caused by defendants’ violations of the Securities Exchange Act of 1934.
Regulus is a biopharmaceutical company that focuses on the discovery and development of drugs that target microRNAs to treat and prevent various diseases, including hepatitis C infections, cardiovascular, fibrosis, oncology, immune-inflammatory, and metabolic diseases. One of its main clinical development products is RG-101, a GalNAc-conjugated anti-miR targeting miR-122 to treat patients with hepatitis C virus infection.
The complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) patients treated with RG-101 were at increased risk of contracting jaundice; (ii) consequently, the Company had overstated RG-101’s approval prospects and/or commercial viability; and (iii) as a result of the foregoing, Regulus’s public statements were materially false and misleading at all relevant times.
On June 27, 2016, post-market, Regulus announced that it had received verbal notice from the U.S. Food and Drug Administration (“FDA”) that the FDA 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 share price fell $2.47, or more than 49%, to close at $2.54 on June 28, 2016.