March 15, 2021 - An amended complaint was filed.

November 5, 2020 - An investor in shares of Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) filed a lawsuit in the U.S. District Court for the Eastern District of New York over alleged violations of Federal Securities Laws by Intercept Pharmaceuticals, Inc. in connection with certain allegedly false and misleading statements made between September 28, 2019 and October 7, 2020.

New York based Intercept Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of therapeutics to treat progressive non-viral liver diseases in the United States, Europe, and Canada. Intercept Pharmaceuticals, Inc’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used for the treatment of primary biliary cholangitis (“PBC”), a rare and chronic liver disease, in combination with ursodeoxycholic acid in adults. The Company 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 of severe liver injuries and deaths linked with its use. Intercept Pharmaceuticals, Inc. reported that its annual Total Revenue rose from $179.8 million in 2018 to $252.00 million in 2019 and that its normalized Loss increased from $309.24 million in 2019 to $344.68 million in 2019.

On May 22, 2020, Intercept Pharmaceuticals, Inc. reported that the FDA “has 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 June 29, 2020, Intercept Pharmaceuticals, Inc. announced that the FDA had issued a Complete Response Letter (“CRL”) rejecting the Company’s NDA for Ocaliva for the treatment of liver fibrosis due to NASH. According to that press release, “[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.” Intercept Pharmaceuticals, Inc. 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 October 8, 2020, news outlets reported that Intercept Pharmaceuticals, Inc. was “facing an investigation from the U.S. Food and Drug Administration over the potential risk of liver injury in patients taking Ocaliva, [Intercept’s] treatment for primary biliary cholangitis, a rare, chronic liver disease.” Shares of Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) declined from $125.00 per share in late 2019 to as low as $27.83 per share on October 23, 2020.

According to the complaint the plaintiff alleges on behalf of purchasers of Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) common shares between September 28, 2019 and October 7, 2020, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between September 28, 2019 and October 7, 2020, the Defendants made false and/or misleading statements and/or failed to disclose that the Defendants downplayed the true scope and severity of safety concerns associated with Ocaliva’s use in treating PBC, that 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, that any purported benefits associated with OCA’s efficacy in treating NASH were outweighed by the risks of its use, that as a result, the FDA was unlikely to approve the Company’s NDA for OCA in treating patients with liver fibrosis due to NASH, and that as a result of all the foregoing, the Company’s public statements were materially false and misleading at all relevant times.