Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.

Inflammation and immunology biotech Apogee Therapeutics and Sagimet Biosciences, a company developing a drug for the fatty liver disease NASH, are the latest biotech companies to join the public markets. Both companies upsized their IPOs, raising cash for clinical trials.

A Madrigal Pharmaceuticals drug for the fatty liver disease NASH has data from a pivotal clinical trial showing improvements in the organ. Based on those results, which sent Madrigal’s stock price soaring more than 200%, the biotech is planning to seek what could become the first regulatory approval of a therapy for this metabolic disorder.

Ipsen is paying €120 million up front to acquire global rights to elafibranor, a Genfit drug that fell short as a treatment for NASH, but is currently in Phase 3 testing in another liver disease, primary biliary cholangitis. Meanwhile, Genfit is adding an early-stage drug candidate to its own pipeline via a separate transaction.

GlaxoSmithKline sees enough promise in the early clinical data of a novel NASH drug to pay its developer, Arrowhead Pharmaceuticals, $120 million up front for rights to the experimental therapy. The Arrowhead drug uses RNA interference to “silence” an enzyme associated with the progression of the fatty liver disease.

Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019 R&D alliance.

Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.

The company is hoping to close its seed funding round in the next six months and aims to be in a position to seek regulatory approval for its lead asset, PLX888, in acute alcoholic hepatitis in 2023.

The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.

The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.

The FDA has requested additional data from the company’s clinical trial. Intercept’s CEO expressed disappointment at the decision, saying the agency had not communicated that the drug, obeticholic acid, was not approvable.

The company said that the agency had requested additional data for obeticholic acid and thus pushed the upcoming advisory committee meeting back from June 9, thereby delaying its decision on approval, which had also been scheduled for June 26.

The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept’s obeticholic acid.

These are four companies that currently have drugs in Phase III development for nonalcoholic steatohepatitis or have them under Food and Drug Administration review.

BI said it would continue to develop the drug, BI 1467335, in other diseases and remain committed to NASH overall. Shares of the Australian company from which it licensed the drug, Pharmaxis, fell more than 40%.

While the FDA’s scheduling an expert panel meeting for obeticholic acid after the original action date would delay its decision, an analyst wrote it would still likely be the first to win approval in NASH.

The agency said it would likely require such drugs to undergo the traditional approval pathway, as there is insufficient evidence to support giving drugs accelerated approval based on surrogate endpoints.

An analyst wrote that with selonsertib’s failures in fourth- and now third-stage fibrosis, the drug will have no place in NASH treatment. Gilead has entered partnerships focused on other compounds for the fatty liver disease.

The deal comes days after Gilead partnered on clinical development in NASH with Denmark’s Novo Nordisk, and two months after the high-profile failure of a Phase III study in the disease.

The company’s stock was nevertheless down more than 13 percent amid investor concerns about lack of intent-to-treat analysis on two-stage fibrosis improvement and gall stone events.

The deal includes a $310 million upfront payment plus milestones for three IFM Tre assets – one clinical drug for NASH and atherosclerosis and two preclinical molecules.

The French company, developing a drug to treat nonalcoholic steatohepatitis, or NASH, announced the pricing of its shares at $20.32 apiece.

The company, one of several developing drugs for the growing fatty liver disease, said in an SEC filing that it would sell its shares at $26.33 apiece.

Shares of the New York-based company jumped nearly 20 percent Tuesday on news that the REGENERATE study of obeticholic acid showed strong improvement in NASH-related liver fibrosis.

The company said a Phase III study of selonsertib had failed, sending shares down 4 percent and feeding analyst pessimism on another Phase III study of the drug in patients with less advanced disease.

Venture capital firm Versant Ventures launched the company with a $20 million Series A funding round last year.

The company joins a growing wave of firms developing drugs for the disease, which has no approved treatments. It expects to enter two drugs into the clinic next year.

The companies will run clinical trials combining Novartis’ tropifexor with any one of several Pfizer drugs under development for the disease, which lacks approved treatments.

The new company is headquartered in San Francisco, with R&D in Israel and has launched a Phase I study of BIO89-100, formerly TEV-47948.

The company secured $60 million in a Series A round from Third Rock and Takeda, plus a partnership with Takeda.