A lawsuit was filed on behalf of investors in Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) shares over alleged securities laws violations.

San Diego, CA -- (SBWire) -- 11/18/2020 --An investor, who purchased NASDAQ: ICPT shares, filed a lawsuit over alleged violations of Federal Securities Laws by Intercept Pharmaceuticals, Inc

Investors who purchased shares of Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) have certain options and for certain investors are short and strict deadlines running. Deadline: January 4, 2021. NASDAQ: ICPT investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Intercept Pharmaceuticals, Inc's lead product candidate is Ocaliva (obeticholic acid ("OCA")), a farnesoid X receptor agonist used for the treatment of primary biliary cholangitis ("PBC"), a rare and chronic liver disease, in combination with ursodeoxycholic acid in adults. The Company is also developing OCA for various other indications, including nonalcoholic steatohepatitis ("NASH").

In 2016, the U.S. Food and Drug Administration ("FDA") granted accelerated approval of Ocaliva for treating 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.

Intercept Pharmaceuticals, Inc. reported that its annual Total Revenue rose from $179.8 million in 2018 to $252.00 million in 2019 and that its normalized Loss increased from $309.24 million in 2019 to $344.68 million in 2019.

On May 22, 2020, Intercept Pharmaceuticals, Inc. 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 June 29, 2020, Intercept Pharmaceuticals, Inc. announced 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." Intercept Pharmaceuticals, Inc. 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 October 8, 2020, news outlets reported that Intercept Pharmaceuticals, Inc. was "facing an investigation from the U.S. Food and Drug Administration over the potential risk of liver injury in patients taking Ocaliva, [Intercept's] treatment for primary biliary cholangitis, a rare, chronic liver disease."

The plaintiff claims that between September 28, 2019 and October 7, 2020, the Defendants made false and/or misleading statements and/or failed to disclose that the Defendants downplayed the true scope and severity of safety concerns associated with Ocaliva's use in treating PBC, that 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, that any purported benefits associated with OCA's efficacy in treating NASH were outweighed by the risks of its use, that 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 that as a result of all the foregoing, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.