Correct Success: SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Intercept Pharmaceuticals, Inc. of Class Action Lawsuit and Upcoming Deadline

NEW YORK, Jan. 2, 2021 /PRNewswire/ — Pomerantz LLP broadcasts {that a} class motion lawsuit has been filed towards Intercept Prescription drugs, Inc. (“Intercept” or the “Firm”) (NASDAQ: ICPT) and sure of its officers. The category motion, filed in United States District Courtroom for the Jap District of New York, and docketed below 20-cv-05377, is on behalf of a category consisting of all individuals aside from Defendants who bought or in any other case, acquired Intercept securities between September 28, 2019 and October 7, 2020, each dates inclusive (the “Class Interval”), searching for to get well damages attributable to Defendants’ violations of the federal securities legal guidelines and to pursue cures below Sections 10(b) and 20(a) of the Securities Change Act of 1934 (the “Change Act”) and Rule 10b-5 promulgated thereunder, towards the Firm and sure of its high officers.

If you’re a shareholder who bought Intercept securities through the class interval, you could have till January 4, 2021, to ask the Courtroom to nominate you as Lead Plaintiff for the category. A replica of the Grievance will be obtained at www.pomerantzlaw.com. To debate this motion, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those that inquire by e-mail are inspired to incorporate their mailing handle, phone quantity, and the variety of shares bought.

[Click here for information about joining the class action]

Intercept is a biopharmaceutical firm that focuses on the event and commercialization of therapeutics to deal with progressive non-viral liver ailments within the U.S.

Intercept’s lead product candidate is Ocaliva (obeticholic acid (“OCA”)), a farnesoid X receptor agonist used for the therapy of main biliary cholangitis (“PBC”), a uncommon and persistent liver illness, together with ursodeoxycholic acid in adults. The Firm can also be creating OCA for numerous different indications, together with nonalcoholic steatohepatitis (“NASH”).

In 2016, the U.S. Meals and Drug Administration (“FDA”) granted accelerated approval of Ocaliva for treating PBC.

Then, in late 2017, each Intercept and the FDA issued warnings regarding the threat of overdosing sufferers with the drug, and a number of stories of extreme liver accidents and deaths linked with its use.

Regardless of these issues, Defendants continued to tout Ocaliva gross sales and purported advantages, and its potential indication for treating numerous different medical situations. For instance, simply two years later, in September 2019, Intercept submitted a New Drug Software (“NDA”) to the FDA for OCA to deal with sufferers with liver fibrosis as a result of NASH.

The criticism alleges that all through the Class Interval, Defendants made materially false and deceptive statements concerning the Firm’s enterprise, operational, and compliance insurance policies. Particularly, Defendants made false and/or deceptive statements and/or didn’t disclose that: (i) Defendants downplayed the true scope and severity of security issues related to Ocaliva’s use in treating PBC; (ii) the foregoing elevated the probability of an FDA investigation into Ocaliva’s improvement, thereby jeopardizing Ocaliva’s continued marketability and the sustainability of its gross sales; (iii) any purported advantages related to OCA’s efficacy in treating NASH had been outweighed by the dangers of its use; (iv) consequently, the FDA was unlikely to approve the Firm’s NDA for OCA in treating sufferers with liver fibrosis as a result of NASH; and (v) on account of all of the foregoing, the Firm’s public statements had been materially false and deceptive in any respect related occasions.

On Might 22, 2020, Intercept reported that the FDA “has notified Intercept that its tentatively scheduled June 9, 2020 advisory committee assembly (AdCom) referring to the corporate’s [NDA] for [OCA] for the therapy of liver fibrosis as a result of [NASH] has been postponed” to “accommodate the evaluate of further knowledge requested by the FDA that the corporate intends to submit throughout the subsequent week.”

On this information, Intercept’s inventory worth fell $11.18 per share, or 12.19%, to shut at $80.51 per share on Might 22, 2020.

On June 29, 2020, Intercept issued a press launch asserting that the FDA had issued a Full Response Letter (“CRL”) rejecting the Firm’s NDA for Ocaliva for the therapy of liver fibrosis as a result of NASH. Based on that press launch, “[t]he CRL indicated that, primarily based on the information the FDA has reviewed to this point,” the FDA “has decided that the expected advantage of OCA primarily based on a surrogate histopathologic endpoint stays unsure and doesn’t sufficiently outweigh the potential dangers to assist accelerated approval for the therapy of sufferers with liver fibrosis as a result of NASH.” The press launch additional suggested, amongst different issues, that the “[t]he FDA recommends that Intercept submit further post-interim evaluation efficacy and security knowledge from the continuing REGENERATE research in assist of potential accelerated approval and that the long-term outcomes section of the research ought to proceed.”

On this information, Intercept’s inventory worth fell $30.79 per share, or 39.73%, to shut at $46.70 per share on June 29, 2020.

Then, on October 8, 2020, information retailers reported that Intercept was “dealing with an investigation from the [FDA] over the potential threat of liver harm in sufferers taking Ocaliva, [Intercept’s] therapy for main biliary cholangitis, a uncommon, persistent liver illness.”

On this information, Intercept’s inventory worth fell $3.30 per share, or 8.05%, to shut at $37.69 per share on October 8, 2020.

The Pomerantz Agency, with workplaces in New York, Chicago, Los Angeles, and Paris is acknowledged as one of many premier companies within the areas of company, securities, and antitrust class litigation. Based by the late Abraham L. Pomerantz, referred to as the dean of the category motion bar, the Pomerantz Agency pioneered the sphere of securities class actions. Right this moment, greater than 80 years later, the Pomerantz Agency continues within the custom he established, combating for the rights of the victims of securities fraud, breaches of fiduciary responsibility, and company misconduct. The Agency has recovered quite a few multimillion-dollar damages awards on behalf of sophistication members. See www.pomerantzlaw.com.

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 7980