After a long run of regulatory stumbles and the recent withdrawal of its lone commercial drug from the U.S. market, Intercept Pharmaceuticals is implementing a restructuring and rounds of job cuts in New Jersey.
Intercept plans to cut 146 employees in three tranches starting Dec. 31, the company revealed in a filing (PDF) to the state. Some of the cuts are set to take effect March 31 and others June 30, according to state records.
The layoff disclosure comes three months after Intercept pulled its troubled farnesoid X receptor (FXR) agonist, Ocaliva, from sale despite years of trying to grow the drug's reach.
First approved in 2016 as a treatment for certain patients with primary biliary cholangitis (PBC), Intercept's drug was once a leading contender in pharma's race to market a drug for nonalcoholic steatohepatitis, now known as metabolic dysfunction-associated steatohepatitis, or MASH.
In 2020, Intercept's first attempt to cross the FDA finish line with Ocaliva in MASH fell short, with the agency citing "uncertain" benefits that it said couldn't justify the risks to patients. A layoff round at the company followed shortly afterward.
A similar storyline played out three years later, with a June 2023 agency rejection prompting the company to abandon the field and trim about a third of its workforce. A couple of months later, the company sold itself to Italian drugmaker Alfasigma.
The MASH shortfalls left the drugmaker to focus on Ocaliva's approved use, PBC, but even there the company had a hard time winning over the FDA.
Last year, the FDA turned down the company's bid to convert Ocaliva's accelerated approval in PBC to a full nod. At the time, the agency granted Intercept the leeway to continue selling the drug under that 2016 accelerated nod.
That changed in 2025, however. Under pressure from the agency, the company in September pulled the drug and acknowledged its trials involving the asset were placed on a clinical hold.
In an August 2025 communication, the FDA told Intercept the drug's postmarketing trial "did not verify clinical benefit" and that patients with early-stage disease "had an excess of liver transplants and deaths," according to a summary of events outlined in the Federal Register.
"Following the withdrawal of Ocaliva from the U.S. market, we are making necessary changes to our business operating model and have filed a WARN notice with the State of New Jersey regarding a planned workforce reduction," a spokesperson for Intercept told Fierce. "We are committed to supporting impacted employees and are taking steps to ensure a smooth transition, while remaining focused on advancing our mission to serve patients."
Nowadays, it appears Intercept's focus is on INT-787, an asset it touts as a "next-generation FXR agonist." The company is testing the candidate in a proof-of-concept study in patients with severe alcohol-associated hepatitis, according to its online pipeline.