After 2 FDA rejections and restructuring drive, Intercept sells itself to Italy's Alfasigma

It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver fibrosis.

Now, Alfasigma has swooped in to take over the struggling drugmaker and its lone commercial product.

Italy’s Alfasigma agreed to merge with Intercept in a cash deal worth $19 per share, representing an 82% premium to Intercept’s September 25 closing stock price. The deal is worth about $800 million in total, according to Reuters.

Intercept's shares were once trading at more than $100 before the FDA dashed its hopes of winning a NASH approval in 2020. The restructuring cut about a third of its workforce, triggering job cuts. A second attempt this year saw the same result, prompting the company to discontinue all NASH-related investments.

Now, Intercept’s remaining staff can join the team at Alfasigma, Alfasigma CEO Francesco Balestrieri said in a statement.

Intercept's focus on liver health makes for a “compelling fit” with Alfasigma’s core business areas of gastroenterology and hepatology, Balestrieri noted.

While Ocaliva never gained FDA approval as the first treatment for NASH patients, it did hit the market in 2016 for certain patients with primary biliary cholangitis (PBC).

The drug brought Intercept to $285.7 million in 2022 revenue. In the second quarter of this year, the company posted sales of $83.7 million, good for 17% growth from the same quarter last year.