NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the Eastern District of New York on behalf of investors that purchased Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) securities between September 28, 2019 and October 7, 2020 (the “Class Period”). Investors have until January 4, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Intercept’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”).
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, Intercept’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.
On this news, Intercept’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 Intercept 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, Intercept’s stock price fell $3.30 per share, or 8.05%, to close at $37.69 per share on October 8, 2020.
The complaint, filed on November 5, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically 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.
If you purchased Intercept securities during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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