According to the law firm press release, 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.
On October 26, 2017, the Court appointed Lead Plaintiffs and Counsel. Lead Plaintiffs filed a consolidated Complaint on December 22. On February 6, 2019, Defendants filed a Motion to Dismiss the consolidated Complaint. The Court issued an Order granting Defendants' Motion to Dismiss on September 5. Plaintiffs were given leave to amend the Complaint. Lead Plaintiffs filed an amended consolidated Complaint on October 1. On December 11, the parties entered into a Stipulation and Agreement of Settlement. On December 20, the Court issued an Order denying preliminary approval of the Settlement.