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Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT)
Copyright © 2006-2020 Law Offices of Howard G. Smith
This lawsuit is for anyone who acquired securities in Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) from September 28, 2019 through October 7, 2020.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by telling investors that the FDA was likely to approve its New Drug Application ("NDA") for Ocaliva for the treatment of nonalcoholic steatohepatitis (“NASH”) when the Company had reason to believe that the FDA would not approve Ocaliva for the treatment of NASH because the Company was withholding from the FDA evidence of liver injury that Ocaliva was causing in patients with primary biliary cholangitis ("PBC"), a disease for which the FDA already approved the drug.  

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, the price of the Company's stock again dropped precipitously on unusually heavy trading volume. Then, 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.” Then,on this news, the price of the Company's stock dropped precipitously on unusually heavy trading volume. Finally, 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 price of the Company's stock again dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) from September 28, 2019 through October 7, 2020 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.
Case Summary
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