NEW YORK–(BUSINESS WIRE) – Scott + Scott Attorneys at Law LLP (“Scott + Scott”), an international shareholder and consumer litigation firm, announces the filing of a class action lawsuit against Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) and some of its officers and directors alleging violations of federal securities laws. If you purchased Intercept stock between September 28, 2019 and October 7, 2020 and suffered a realized or unrealized loss, please contact Scott + Scott’s attorney Joe Pettigrew at 844-818 -6982 or at jpettigrew @ scott-scott. com for more information.
Intercept is a biopharmaceutical company focused on the development and commercialization of therapeutics for the treatment of progressive non-viral liver disease in the US Intercept lead product Ocaliva.
The lawsuit alleges that, during the classroom, Intercept made materially false and / or misleading statements and / or failed to disclose that: (i) Defendants downplayed the true scope and severity of the safety concerns associated with the use of Ocaliva ; (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) alleged benefits related to the effectiveness of Ocaliva have been outweighed by the risks of its use; (iv) As a result, the FDA was unlikely to approve the Company’s New Drug Application (“NDA”) for Ocaliva for the Treatment of Patients to which the Company was marketing. and (v) as a result of all of the foregoing, the Company’s public statements have been materially false and misleading at all relevant times.
On May 22, 2020, Intercept reported that the FDA had postponed an upcoming advisory committee meeting related to the company’s NDA for Ocaliva and that the company needed to provide additional data to the FDA.
In the news, Intercept’s share 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 released a press release announcing that the FDA had issued a full response letter (CRL) denying the company’s NDA for Ocaliva. This press release states: “[t]The CRL stated that the FDA has determined the predicted benefits of Ocaliva based on the data the FDA has reviewed so far. . . remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for treatment of patients. “The press release also disclosed the following:”[t]The FDA recommends[ed] Intercept will provide additional efficacy and safety data following the interim analysis of [an] constantly. . . Study in support of potentially accelerated approval and that the long-term results phase of the study should continue. ”
In the news, Intercept’s share price fell $ 30.79 per share, or 39.73%, to close at $ 46.70 per share on June 29, 2020.
The FDA has continued to investigate the possible side effects of Ocaliva, and Intercept’s stock price has continued to decline. By the time the lawsuit was filed, Intercept’s share price had fallen to $ 29.42, a decrease of nearly 70% from the release of the Truth About Ocaliva’s Side Effects.
What you can do
If you purchased Intercept stock between September 28, 2019 and October 7, 2020 and have any questions about this notice or would like to discuss this lawsuit, please contact Attorney Joe Pettigrew at 844-818-6982 or jpettigrew @ scott -scott.com. The deadline for the lead plaintiff is January 4, 2021.
About Scott + Scott Lawyers LLP
Scott + Scott has extensive law enforcement experience in key securities, antitrust, and retirement plan matters in the United States. The company represents pension funds, foundations, individuals and other companies worldwide with offices in New York, London, Connecticut, California and Ohio.