Novo Nordisk develops broader strategy for MASH and beyond with $4.7B acquisition of Akero

The FDA's recent decision to expand approval of Novo Nordisk's GLP-1 drug Wegovy to treat moderate to advanced fatty liver disease gives Novo Nordisk access to MASH patients. Now, the company is acquiring Akero Therapeutics in a multibillion-dollar deal that brings a late-stage drug candidate with the potential to help patients in the most severe stages of MASH.

Under terms of the deal announced Thursday, Novo Nordisk will pay $54 in cash for each Akero share, valuing the biotech company at $4.7 billion. The contingent value rights in the deal obligate the Danish pharmaceutical giant to pay an additional $6 per share in cash upon FDA approval of Akero's drug efruxifermin for the treatment of compensated cirrhosis caused by MASH. Achieving this goal will require an additional $500 million in spending.

Speaking on a conference call Thursday, Novo Nordisk CEO Mike Doustdar noted that the Akero deal is the largest R&D acquisition in the company's history. It was also the first time since he took over as CEO in August.

“While many external factors challenge us every day, part of my job is to ensure progress on our long-term aspirations and ensure leadership in the field of diabetes and obesity and their related comorbidities,” said Dustdahl. “We can only achieve this by raising the bar for innovation and bringing innovative medicines to market that impact millions of patients around the world. Today's acquisition further enhances the possibility of achieving this goal.”

MASH, short for metabolic dysfunction-associated steatohepatitis, occurs as fat accumulates in the liver, causing inflammation and the formation of scar tissue. The extent of this liver scarring is called fibrosis and is measured on a scale from F0, which represents no fibrosis, to F4, which represents cirrhosis. According to the FDA, approximately 14.9 million Americans have MASH. Novo Nordisk estimates that the disease affects more than 250 million people globally.

Akero's efruxifermin is a modified protein that is a long analog of fibroblast growth factor 21 (FGF21), a hormone secreted by the liver that regulates energy expenditure and fat metabolism. The half-life of natural FGF21 is less than two hours. South San Francisco-based Akero designed efruxifermin with a half-life that lasts several days, allowing the drug to be injected once a week. In early 2025, Akero reported Phase 2 results showing statistically significant reversal of cirrhosis with no worsening of MASH over 96 weeks of treatment with efruxifermin. To date, efruxifermin is the only drug to show this effect in patients with F4 fibrosis.

Novo Nordisk's Wegovy, which works by activating GLP-1 receptors, added MASH to its label in August. This FDA decision applies only to MASH patients with F2 and F3 fibrosis. The company said there is still an unmet medical need. In addition to the untreated F4 patient population, some patients with moderate to severe disease may not respond to GLP-1 drugs, the company said in an investor presentation.

MASH was once a graveyard for drug research, but that has changed in recent years. In 2024, Madrigal Pharmaceuticals received its first MASH approval for Rezdiffra, an orally administered small molecule designed to activate THR-β, a receptor that mediates metabolic activity in the liver. Rezdiffera's accelerated approval covers the treatment of moderate to severe MASH.

The Akero acquisition agreement comes three weeks after Roche announced a $2.4 billion deal to acquire 89bio and its late-stage MASH drug. Like Akero's drug, 89bio's pegozafermin is a modified protein designed to mimic FGF21. The bi-weekly injection technology gives the drug a longer half-life compared to weekly injections of Akero, which will provide patients with dosing advantages. Two Phase 3 tests of 89bio's drug are underway. Meanwhile, GSK has mid-stage candidate efimosfermin, which it acquired earlier this year in a $1.2 billion deal with Boston Pharmaceuticals. This FGF21 analog has a longer half-life and is designed to support once-monthly dosing.

Leerink Partners analyst Thomas Smith noted in a note to investors that the Akero deal marks the third MASH-related acquisition this year — all targeting FGF21 target assets. The deals reinforce Leerink's view that this drug class is one of the most compelling to address fibrosis in MASH. Smith added that the Akero acquisition comes two months after Novo terminated its in-house FGF21 program due to phase 2 study failures, highlighting that not all FGF21 analogs are created equal. While Leerink expects the deal to close, Smith said there may be some scrutiny from the Federal Trade Commission given the overlapping pipelines of the two companies. There may also be political scrutiny.

Of the three FGF21 MASH drug acquisitions this year, the Akero deal is the largest. Martin Holst Lange, executive vice president of research and development and chief scientific officer, said the premium Novo Nordisk paid was reasonable. Just as Novo Nordisk saw a difference in the GLP-1 space, it also sees a difference in the FGF21 drug, he said. Efruxifermin is not only different from Novo's internally developed FGF21 drug candidates, it has shown superior efficacy and potentially better safety and tolerability compared to other FGF21 drugs to date.

“So we believe that with this acquisition, we have good potential to not only be a best-in-class business, but it's clearly a good time, first-in-class, because it's a more progressive program,” Langer said.

Three Phase 3 studies of efruxifermin are ongoing, enrolling a total of approximately 3,500 participants. The first readings from real-world studies are expected as early as next year, with additional studies producing data in the coming years. In the meantime, Lange said the company plans to explore potential combinations of efruxifermin with its GLP-1 drug portfolio. The company will also study Akero's drug in other indications.

The $54 per share Novo paid for Akero represents only a 16% premium to the stock's closing price on Wednesday, but a 42% premium to Akero's closing price on May 19, before the takeover rumors emerged. The terms of the contingent value rights require efruxifermin to obtain FDA approval by June 30, 2031.

The acquisition has been approved by Akero's board of directors, but is subject to shareholder and regulatory approval. The companies expect to close the deal by the end of this year.

Photo: Liselotte Sabroe/Scanpix Denmark/AFP via Getty Images