NEW YORK--(BUSINESS WIRE)--Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international shareholder and consumer rights litigation firm, announces the filing of a federal class action lawsuit against Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) and certain 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 have suffered a loss, realized or unrealized, you are encouraged to contact Scott+Scott attorney Joe Pettigrew at 844-818-6982 or jpettigrew@scott-scott.com for more information.
Intercept is a biopharmaceutical company that focuses on the development and commercialization of therapeutics to treat progressive non-viral liver disease in the U.S. Intercept’s lead product is Ocaliva.
The lawsuit alleges that, during the Class Period, Intercept made materially 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; (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 Ocaliva’s efficacy were 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 in treating patients that the Company was marketing to; 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 had postponed an upcoming advisory committee meeting related to the Company’s NDA for Ocaliva and that the Company had to provide the FDA with additional data.
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.
Then, on June 29, 2020, Intercept issued a press release disclosing that the FDA had issued a Complete Response Letter (“CRL”) rejecting the Company’s NDA for Ocaliva. 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 Ocaliva . . . remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients.” The press release also disclosed, among other things, that “[t]he FDA recommend[ed] that Intercept submit additional post-interim analysis efficacy and safety data from [an] ongoing . . . 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.
The FDA has continued to investigate the potential side effects of Ocaliva and Intercept’s stock price has continued to drop. At the time the lawsuit was filed, Intercept’s stock price had dropped as low as $29.42, down almost 70% from before the truth about Ocaliva’s side effects were disclosed.
What You Can Do
If you purchased Intercept stock between September 28, 2019 and October 7, 2020, and you have questions about this notice or wish to discuss this lawsuit, please contact attorney Joe Pettigrew at 844-818-6982, or jpettigrew@scott-scott.com. The lead plaintiff deadline is January 4, 2021.
About Scott+Scott Attorneys at Law LLP
Scott+Scott has significant experience in prosecuting major securities, antitrust, and employee retirement plan actions throughout the United States. The firm represents pension funds, foundations, individuals, and other entities worldwide with offices in New York, London, Connecticut, California, and Ohio.
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