Intercept’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used for the treatment of a rare and chronic liver disease, primary biliary cholangitis (“PBC”), in combination with ursodeoxycholic acid in adults. Intercept is also developing OCA for various other indications, including nonalcoholic steatohepatitis (“NASH”).
In 2016, accelerated approval of Ocaliva for treating PBC was granted by the U.S. Food and Drug Administration (“FDA”).
Then, in late 2017, both the FDA and Intercept issued warnings concerning the risk of overdosing patients with the drug, including multiple reports of severe liver injuries and deaths linked with its use.
Defendants continued to tout Ocaliva sales and purported benefits, and its potential indication for treating various other medical conditions, despite these concerns, . For example, in September 2019, Intercept submitted a New Drug Application (“NDA”) to the FDA for OCA to treat patients with liver fibrosis due to NASH.
It is alleged in the complaint that Intercept, throughout the Class Period, made materially misleading and false statements regarding the their business, operational, and compliance policies. Specifically, Intercept made misleading and/or false statements and/or failed to disclose that: (i) Defendants downplayed the severity and true scope of safety concerns associated with Ocaliva’s use in treating PBC; (ii) the foregoing increased the likelihood of an investigation into Ocaliva’s development by the FDA, thereby jeopardizing Ocaliva’s the sustainability of its sales and continued marketability; (iii) the risks of its use outweighed any purported benefits associated with OCA’s efficacy in treating NASH; (iv) the FDA was unlikely to approve the Company’s NDA for OCA in treating patients with liver fibrosis due to NASH, as a result,; and (v) Intercept’s public statements were materially misleading and false at all relevant times, as a result of all the foregoing, .
Intercept reported on May 22, 2020 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 May 22, 2020, Intercept’s stock price fell $11.18 per share, or 12.19%, to close at $80.51 per share on this news.
Intercept issued a press release on June 29, 2020 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.” Among other things, it was further advised in this press release, 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 June 29, 2020, Intercept’s stock price fell $30.79 per share, or 39.73%, to close at $46.70 per share on this news.
Then, on October 8, 2020, various 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 October 8, 2020, Intercept’s stock price fell $3.30 per share, or 8.05%, to close at $37.69 per share on this news.
Intercept Pharmaceuticals, Inc.
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