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Intercept (ICPT) Stock Down on FDA Committee Update on NDA

Intercept Pharmaceuticals, Inc. ICPT announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the FDA will discuss the company’s new drug application (NDA) for obeticholic acid (OCA). The NDA is seeking approval for the candidate as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). The meeting will take place on May 19, 2023.

Shares were down 13.93% on the news. The outcome of the meeting will provide insights to the FDA, which is scheduled to make a decision regarding the same on Jun 22, 2023. Investors are skeptical, as Intercept previously faced roadblocks to getting its NDA accepted.

In June 2020, Intercept received a complete response letter (“CRL”) from the FDA stating that its NDA for OCA for the treatment of liver fibrosis due to NASH could not be approved in its present form. The CRL indicated that 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.

This analysis was based on the data reviewed by the agency. The FDA then recommended 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 trial should continue.

Nevertheless, in January 2023, the FDA accepted the NDA, indicating its consideration of this as a complete Class 2 resubmission and assigned a target action date of Jun 22, 2023.

NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.

A potential approval of OCA for NASH will give a significant boost to Intercept. With no treatments currently approved to address this disease, the market opportunity is substantially large.

Shares of the company are up 12.1% in the past year as against the industry’s decline of 11.3%.


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OCA is approved under the brand name Ocaliva for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.

While the NASH market promises potential with no approved therapies yet, it is challenging.

Quite a few players are trying their hand at successfully developing a treatment for the same condition.

A clinical-stage biopharmaceutical company, Madrigal Pharmaceuticals, Inc. MDGL, reported positive top line results in December 2022 from the phase III MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. Madigral remains on track to file its NDA for resmetirom in the first half of 2023.

Another company, Viking Therapeutics VKTX, is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. Viking initiated the VOYAGE study, a phase IIb study designed to evaluate VK2809 in patients with NASH and fibrosis.

Intercept currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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