Novo Nordisk to acquire Akero Therapeutics and its promising phase 3 FGF21 analogue to expand MASH portfolio

Novo Nordisk today announced that it has entered into a definitive agreement to acquire Akero Therapeutics, Inc. (Akero), a publicly held clinical-stage company developing innovative treatments for patients with serious metabolic diseases marked by a high unmet medical need. Akero’s fibroblast growth factor 21 (FGF21) analogue efruxifermin (EFX) is a potentially best-in-class treatment for metabolic dysfunction-associated steatohepatitis (MASH). EFX is currently in phase 3 development for the treatment of patients with moderate to advanced liver fibrosis (F2-F3) and patients with cirrhosis (F4).

Strategic and portfolio fit
The acquisition reflects Novo Nordisk’s long-term strategy to develop innovative and differentiated medicines and treat millions of more people living with diabetes, obesity and their associated comorbidities. With more than 40% of MASH patients also having type 2 diabetes, and over 80% of MASH patients being overweight or living with obesity, MASH is closely linked with Novo Nordisk’s expertise in diabetes and obesity.

“MASH destroys lives silently – and efruxifermin has the potential to change that by reversing liver damage,” said Mike Doustdar, President and CEO of Novo Nordisk. “If approved, we believe it could become a cornerstone therapy, alone or together with Wegovy^® (semaglutide), to tackle one of the fastest-growing metabolic diseases of our time. This acquisition embodies Novo Nordisk’s relentless ambition to move faster, go further, and ultimately deliver on our commitment to pursue leadership in diabetes, obesity and their associated comorbidities.”

EFX is currently being evaluated as a once-weekly subcutaneous injection in the phase 3 SYNCHRONY programme, which consists of three clinical trials designed to support regulatory approval for the treatment of pre-cirrhotic (F2-F3) MASH and compensated cirrhosis (F4) due to MASH.

The phase 3 programme builds on two 96-week phase 2b trials, in which EFX has been observed to significantly improve liver fibrosis and reverse compensated cirrhosis due to MASH. Over 96 weeks, the HARMONY (F2-F3) and SYMMETRY (F4) trial demonstrated 49% and 29% reduction in fibrosis without worsening of MASH respectively, compared to 19% and 11% in the respective placebo groups¹. EFX is the only treatment to have shown significant fibrosis regression in F4 patients in a phase 2 trial.

“Efruxifermin complements Novo Nordisk’s leading portfolio and is aligned with our commitment to building a competitive portfolio of treatment options across the stages of MASH. Within MASH, there remains a huge medical need for effective treatment options, especially in the later stages of the disease,” said Martin Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. “Based on the data generated by Akero, we believe efruxifermin could be a first- and best-in-class treatment for mid- to late-stage MASH with the potential to reverse liver damage. Novo Nordisk is uniquely positioned to unlock the full potential of efruxifermin and reach more patients living with MASH.”

Transaction terms
Under the terms of the agreement, Novo Nordisk will acquire all outstanding shares of Akero’s common stock at a price of 54 USD per share in cash (or aggregated value of 4.7 billion USD) at closing. In addition, Akero shareholders will receive a non-transferable CVR entitling holders to a potential additional payment of 6 USD per share in cash (or aggregated value of 0.5 billion USD) upon US regulatory approval of EFX for the treatment of compensated cirrhosis due to MASH.

The transaction has been unanimously approved by Akero’s Board of Directors and is expected to close around the turn of the year, upon satisfaction of customary closing conditions including approvals by regulatory authorities.

Novo Nordisk is represented by BofA Securities as its financial advisor and Ropes & Gray as its legal advisor.

Financial implications
The transaction is not expected to impact Novo Nordisk’s previously communicated operating profit outlook for 2025. The free cash flow outlook for 2025 is expected to be negatively impacted by approximately 4 billion USD, reflecting the expected enterprise value at closing. The implied 2025 free cash flow outlook is therefore 9-19 billion DKK depending on the timing of closing.

For 2026, the acquisition is expected to lead to increased research and development costs, with an estimated negative impact on full year operating profit growth in 2026 of around 3%-points, depending on the timing of closing. The transaction will be mainly debt financed.

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