GlobeNewswire Inc | Nov 12, 2020 02:12PM EST

November 12, 2020

NEW YORK, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP (Wolf Haldenstein) announces that a federal securities class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of investors who purchased or otherwise acquired Intercept Pharmaceuticals, Inc. (Intercept or the Company) (NASDAQ:ICPT) securities betweenSeptember 28, 2019 and October 7, 2020inclusive (the Class Period).

All investors whopurchasedsharesofIntercept Pharmaceuticals, Inc.and incurred losses areurgedto contact the firm immediately at classmember@whafh.com or (800) 575-0735 or (212) 545-4774.You may obtain additional information concerning the action or join the case on our website, www.whafh.com.

If you have incurred losses in the shares of Intercept Pharmaceuticals, Inc.,you may,nolater than January 4, 2021, request that the Court appoint you lead plaintiff of the proposed class.

CLICK HERE TO JOIN THIS CASE

The filed complaint 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 Companys business, operations, and prospects. Specifically, Defendants failed to disclose to investors that:

-- Defendants downplayed the true scope and severity of safety concerns associated with Ocalivas use in treating PBC; -- the foregoing increased the likelihood of an FDA investigation into Ocalivas development, thereby jeopardizing Ocalivas continued marketability and the sustainability of its sales; -- any purported benefits associated with OCAs efficacy in treating NASH were outweighed by the risks of its use; -- as a result, the FDA was unlikely to approve the Companys NDA for OCA in treating patients with liver fibrosis due to NASH; and -- as a result of all the foregoing, the Companys public statements were materially false and misleading at all relevant times.

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 companys [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, Intercepts 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 Companys 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, [Intercepts] treatment for primary biliary cholangitis, a rare, chronic liver disease.

On this news, the Companys stock price fell an additional $3.30 per share, or 8%, to close at $37.69 per share on October 8, 2020.

Wolf Haldenstein has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.

If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735, via e-mail at classmember@whafh.com, or visit our website at www.whafh.com.

Contact:

Wolf Haldenstein Adler Freeman & Herz LLP Kevin Cooper, Esq.Gregory Stone, Director of Case and Financial AnalysisEmail: gstone@whafh.com,kcooper@whafh.com or classmember@whafh.comTel: (800) 575-0735 or (212) 545-4774

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