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Intercept Pharmaceuticals, Inc.

Company NameIntercept Pharmaceuticals, Inc.
Stock SymbolICPT
Class PeriodSeptember 28, 2019 to October 07, 2020
Lead Plaintiff Motion DeadlineJanuary 04, 2021

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. Its lead product candidate is Ocaliva (“OCA”) used for the treatment of primary biliary cholangitis (“PBC”). The Company is also developing Ocaliva for other indications, including nonalcoholic steatohepatitis (“NASH”).

 

On May 22, 2020, Intercept stated that the U.S. Food and Drug Administration (“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 this news, Intercept’s stock price fell $11.18 per share, or 12%, to close at $80.51 per share on May 22, 2020.

 

On June 29, 2020, Intercept disclosed receipt of a Complete Response Letter (“CRL”) from the FDA rejecting its NDA for Ocaliva for the treatment of liver fibrosis due to NASH. According to the CRL, “[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, the Company’s stock price fell $30.79 per share, or nearly 40%, to close at $46.70 per share on June 29, 2020.

 

On October 8, 2020, news outlets reported that the Company 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, the Company’s stock price fell $3.30 per share, or 8%, to close at $37.69 per share on October 8, 2020.

 

The complaint filed in this class action 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 failed to disclose to investors that: (1) Defendants downplayed the true scope and severity of safety concerns associated with Ocaliva’s use in treating PBC; (2) 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; (3) any purported benefits associated with OCA’s efficacy in treating NASH were outweighed by the risks of its use; (4) 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 (5) as a result of all the foregoing, the Company’s public statements were materially false and misleading at all relevant times.

 

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