NEW YORK, Dec. 05, 2020 (GLOBE NEWSWIRE) -- Bernstein Liebhard, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the securities of Intercept Pharmaceuticals Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) from September 28, 2019, through October 7, 2020 (the “Class Period”). The lawsuit filed in the United States District Court for the Eastern District of New York alleges violations of the Securities Exchange Act of 1934.
If you purchased Intercept securities, and/or would like to discuss your legal rights and options please visit Intercept Shareholder Lawsuit or contact Joseph R. Seidman Jr. toll free at (877) 779-1414 or Seidman@bernlieb.com.
The complaint alleges that throughout the Class Period, 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, 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. 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, 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.
If you wish to serve as lead plaintiff, you must move the Court no later than January 4, 2021. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
If you purchased Intercept securities, and/or would like to discuss your legal rights and options please visit https://www.bernlieb.com/cases/interceptpharmaceuticalsinc-icpt-shareholder-class-action-lawsuit-stock-fraud-331/apply/ or contact Joseph R. Seidman Jr. toll free at (877) 779-1414 or Seidman@bernlieb.com.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.
ATTORNEY ADVERTISING. © 2020 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. The lawyer responsible for this advertisement in the State of Connecticut is Michael S. Bigin. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Joseph R. Seidman, Jr.
Bernstein Liebhard LLP