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NEW YORK, November 7, 2020 (GLOBE NEWSWIRE) – Pomerantz LLP announces that a class action lawsuit has been filed against Intercept Pharmaceuticals, Inc. (“Intercept” or the “Company”) (NASDAQ: ICPT) and some of its officers. The class action, filed with the United States District Court for the Eastern District of New York, and registered under 20-cv-05377, is in the name of a class made up of all persons other than the defendants who have purchased or otherwise acquired securities between September 28, 2019 and October 7, 2020, both dates (the “Class Period”), seeking to recover damages caused by Defendants’ violations of federal securities laws and to pursue remedies under Sections 10 ( b) and 20 (a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 enacted under it, against the Company and some of its senior officers.
If you are a shareholder who purchased Intercept stock during the period of the class, you have until January 4, 2021 to ask the Court to appoint you as lead actor for the class. A copy of the complaint can be obtained a www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free number, ext. 7980. Those requesting information by e-mail are encouraged to include their postal address, telephone number and number of shares purchased.
[Click here for information about joining the class action]
Intercept is a biopharmaceutical company that focuses on the development and commercialization of therapies for the treatment of progressive non-viral liver disease in the United States
The main candidate product of Intercept is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used to treat primary biliary cholangitis (“PBC”), a rare and chronic liver disease, in combination with ursodeoxycholic acid in adults. The Company is also developing OCA for various other indications, including non-alcoholic steatohepatitis (“NASH”).
In 2016, the US Food and Drug Administration (“FDA”) granted accelerated approval of Ocaliva for the treatment of PBC.
Then, in late 2017, both Intercept and the FDA issued warnings about the risk of patients overdosing with the drug and multiple reports of severe liver injury and deaths related to its use.
Despite these concerns, defendants continued to publicize Ocaliva’s sales and alleged benefits and its potential indication for the treatment of various other medical conditions. For example, just two years later, in September 2019, Intercept filed a new drug application (“NDA”) with the FDA for OCA for the treatment of patients with liver fibrosis due to NASH.
The complaint states that during the lecture period, defendants made materially false and misleading statements regarding the Company’s corporate, operational and compliance policies. In particular, the defendants have made false and / or misleading statements and / or have not disclosed that: (i) the defendants have downplayed the true extent and seriousness 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, 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, ”
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