NEW YORK, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) in the United States District Court for the Eastern District of New York on behalf of those who purchased or acquired the securities of Intercept between September 28, 2019 and October 7, 2020, inclusive (the “Class Period”). The lawsuit seeks to recover damages for Intercept investors under the federal securities laws.

The Complaint alleges that 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.

On May 22, 2020, Intercept 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 this news, the Company’s stock price fell $11.18 per share, or 12.19%, to close at $80.51 per share on May 22, 2020.

On June 29, 2020, Intercept issued a press release announcing 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.” The press 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, the Company’s stock price fell $30.79 per share, or 39.73%, to close at $46.70 per share on June 29, 2020.

Then, 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 8.05%, to close at $37.69 per share on October 8, 2020.

Investors who purchased or otherwise acquired shares of Intercept during the Class Period should contact the Firm prior to the January 4, 2021 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.

Please visit our website at http://www.gme-law.com for more information about the firm.

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