The biopharma company Regulus Therapeutics was recently hit with a securities class action lawsuit related to one of the drugs it was testing. To learn more about this case, visit Battea’s Regulus case summary.
Specifically, the company’s RG-101 drug allegedly put patients at greater risk of contracting jaundice, among other reported issues, and the suit states that Regulus and certain of its executives made false or misleading statements about these issues, or failed to disclose them. The suit, filed in the U.S. District Court for the Southern District of California, further alleges that Regulus overstated the efficacy of RG-101’s chances of being approved by the U.S. Food and Drug Administration, and its commercial viability. As a result of these issues, the suit alleges that all public statements about RG-101 may have been materially false or misleading.
The class action suit has a class period from Jan. 21, 2016, to June 27, 2016.
RG-101 – a drug designed to help treat Hepatitis C – recently completed its Phase II study, and Regulus alerted the FDA that it would keep RG-101’s clinical development on hold, according to the firm’s fourth-quarter 2016 filings. The government agency requested more data from Regulus about the safety and efficacy of the drug related to other ongoing studies, and that information likely won’t be available until the fourth quarter of this year.
Part of the reason for the hold on further studies was that of the 79 patients treated with various types of RG-101 treatments, 10 suffered relapses, Regulus further reported. Those in the trial suffered a number of adverse events as a result of the drug, including fatigue, headaches and reactions at the injection site. Moreover, four patients reported asymptomatic transient hyperbilirubinemia, and seven experienced more serious adverse events, including one instance of jaundice, one of trauma-related knee injury, and one of an upper respiratory infection.
Meanwhile, Regulus also reported its financial results, which saw revenues decline sharply on a year-over-year basis, leading to net losses of $20 million for the quarter and $81.8 million for the year. At the end of 2015, the company had suffered net losses of $7.2 million for the final quarter and $55.7 million for the year.
The impact on stock prices
At the start of the suit’s class period in late January of last year, Regulus stock was trading at about $6.44 per share, a number that rose to $8.11 by early April. Since then, however, the price has been on a slow but steady decline, including a significant downturn at the end of the class period when the FDA announced the initial hold. On June 27, the stock held at $5.01 per share, but by the next day had declined to just $2.54. It has been on a slow decline ever since, and now stands at just $1.10 per share.