Intercept Pharmaceuticals, Inc. Class Action Lawsuit
- Company Name
- Intercept Pharmaceuticals, Inc.
- Stock Symbol
- Class Period
- September 28, 2019 to October 7, 2020
- Motion Deadline
- January 4, 2021
- Eastern District of New York
The Intercept Pharmaceuticals, Inc. class action lawsuit charges Intercept and certain of its executives with violations of the Securities Exchange Act of 1934 and seeks to represent purchasers or acquirers of Intercept securities between September 28, 2019 and October 7, 2020, inclusive (the “Class Period”). The Intercept class action lawsuit was commenced on November 5, 2020 in the Eastern District of New York and is captioned Chauhan v. Intercept Pharmaceuticals, Inc., No. 20-cv-05377.
Intercept is a biopharmaceutical company that focuses on the development and commercialization of therapeutics to treat progressive non-viral liver diseases in the United States. Intercept’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used in combination with ursodeoxycholic acid in adults for the treatment of primary biliary cholangitis (“PBC”), a rare and chronic liver disease. Intercept is also developing OCA for various other indications, including nonalcoholic steatohepatitis (“NASH”). In 2016, the U.S. Food and Drug Administration (“FDA”) granted accelerated approval of Ocaliva for treating PBC. Then, in late 2017, both Intercept and the FDA issued warnings concerning the risk of overdosing patients with the drug, and multiple reports linked severe liver injuries and deaths to its use.
Despite these concerns, the Intercept class action lawsuit alleges that defendants continued to tout Ocaliva sales and the drug’s purported benefits, including its potential indication for treating various other medical conditions. For example, just two years later, in September 2019, Intercept submitted a New Drug Application (“NDA”) to the FDA for OCA to treat patients with liver fibrosis due to NASH.
The Intercept class action lawsuit further alleges that during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (i) defendants had downplayed the true scope and severity of safety concerns associated with Ocaliva’s use in treating PBC; (ii) the foregoing increased the likelihood of an FDA investigation into Ocaliva’s development, thereby jeopardizing Ocaliva’s continued marketability and the sustainability of its sales; (iii) any purported benefits associated with OCA’s efficacy in treating NASH were outweighed by the risks of its use; (iv) as a result, the FDA was unlikely to approve Intercept’s NDA for OCA in treating patients with liver fibrosis due to NASH; and (v) as a result of the foregoing, Intercept’s public statements were materially false and misleading at all relevant times.
On May 22, 2020, Intercept reported that the FDA “ha[d] notified Intercept that its tentatively scheduled June 9, 2020 advisory committee meeting (AdCom) relating to the company’s [NDA] for [OCA] for the treatment of liver fibrosis due to [NASH] has been postponed” to “accommodate the review of additional data requested by the FDA that the company intends to submit within the next week.” On this news, Intercept’s stock price fell more than 12%.
Then, on June 29, 2020, Intercept issued a release announcing that the FDA had issued a Complete Response Letter (“CRL”) rejecting Intercept’s NDA for Ocaliva for the treatment of liver fibrosis due to NASH. According to Intercept, “[t]he CRL indicated that, based on the data the FDA has reviewed to date,” the FDA “has determined that the predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.” The release further advised, among other things, that the “[t]he FDA recommends that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the study should continue.” On this news, Intercept’s stock price fell nearly 40%.
Finally, on October 8, 2020, news outlets reported that Intercept was “facing an investigation from the [FDA] over the potential risk of liver injury in patients taking Ocaliva, [Intercept’s] treatment for primary biliary cholangitis, a rare, chronic liver disease.” On this news, Intercept’s stock price fell an additional 8%, further damaging investors.
The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Intercept securities during the Class Period to seek appointment as lead plaintiff in the Intercept class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Intercept class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Intercept class action lawsuit. An investor’s ability to share in any potential future recovery of the Intercept class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Intercept class action lawsuit or have questions concerning your rights regarding the Intercept class action lawsuit, please provide your information here or contact counsel, J.C. Sanchez of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at email@example.com. Lead plaintiff motions for the Intercept class action lawsuit must be filed with the court no later than January 4, 2021.
Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations and the media as leading lawyers in the industry.