Intercept Pharmaceuticals, Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Eastern District of New York on behalf of those who acquired Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) securities during the period from September 28, 2019 through October 7, 2020, both dates inclusive (the “Class Period”). Investors have until January 4, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Intercept is a biopharmaceutical company that focuses on the development and commercialization of therapeutics to treat progressive non-viral liver diseases in the U.S. Intercept’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)). In 2016, the U.S. Food and Drug Administration (“FDA”) granted accelerated approval of Ocaliva for treating primary biliary cholangitis (“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. Despite these concerns, Defendants continued to tout Ocaliva sales and purported benefits, and 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 complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants 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 the Company’s NDA for OCA in treating patients with liver fibrosis due to NASH; and (v) as a result of all the foregoing, the Company’s public statements were materially false and misleading at all relevant times.
If you acquired Intercept securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney at 212-371-6600, by email at email@example.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.