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NEW YORK, November 6, 2020 (GLOBE NEWSWIRE) – Gainey McKenna & Egleston announces that a class action has been filed against Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) in the US District Court. United States for the Eastern District of New York on behalf of those who purchased or acquired Intercept securities between September 28, 2019 and October 7, 2020 inclusive (the “Class Period”). The lawsuit aims to recover damages for Intercept’s investors under federal securities laws.
The complaint states that the defendants have made false and / or misleading statements and / or have not disclosed that: (i) the defendants have downplayed the true extent and severity of the safety concerns associated with the use of Ocaliva in the treatment of PBC; (ii) the foregoing has 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 alleged benefits associated with the efficacy of OCA in the treatment of NASH have been outweighed by the risks of its use; (iv) as a result, the FDA was unlikely to approve the Society’s NDA for OCA in the treatment of patients with liver fibrosis due to NASH; and (v) as a result of all of the foregoing, the Company’s public statements were substantially false and misleading at all relevant times.
On May 22, 2020, Intercept reported that the FDA “notified Intercept that the advisory committee (AdCom) meeting scheduled for June 9, 2020 relating to the company [NDA] for [OCA] for the treatment of hepatic fibrosis due to [NASH] has been postponed “to” accommodate the review of additional FDA-required data that the company intends to submit within the next week. “Based on this news, the Company’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 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, ”
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