BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) securities between September 28, 2019 and October 7, 2020, inclusive (the “Class Period”). Intercept investors have until January 4, 2021 to file a lead plaintiff motion.
Investors suffering losses on their Intercept investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.
Intercept is a biopharmaceutical company that focuses on the development and commercialization of therapeutics to treat progressive non-viral liver diseases in the U.S. Its lead product candidate is Ocaliva (“OCA”) used for the treatment of primary biliary cholangitis (“PBC”). The Company is also developing Ocaliva for other indications, including nonalcoholic steatohepatitis (“NASH”).
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, Intercept’s 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 Company’s 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, [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%, to close at $37.69 per share on October 8, 2020.
The complaint filed in this class action 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 Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Defendants downplayed the true scope and severity of safety concerns associated with Ocaliva’s use in treating PBC; (2) 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; (3) any purported benefits associated with OCA’s efficacy in treating NASH were outweighed by the risks of its use; (4) 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 (5) 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, have information or 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 Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.
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