Danish pharma giant Novo Nordisk has signed a definitive agreement to acquire Akero Therapeutics, a San Francisco-based clinical-stage biopharmaceutical company focused on developing innovative therapies for serious metabolic diseases.

The acquisition will bring a potential best-in-class treatment for metabolic dysfunction-associated steatohepatitis (MASH) to Novo Nordisk’s portfolio — Akero’s fibroblast growth factor 21 (FGF21) analogue, efruxifermin (EFX).

EFX is currently in phase 3 development for the treatment of patients with moderate to advanced liver fibrosis and patients with cirrhosis. In phase 2 trials, the therapy demonstrated significant improvement in liver fibrosis and reversal of compensated cirrhosis associated with MASH. It is being evaluated as a once-weekly subcutaneous injection in the phase 3 SYNCHRONY programme, which comprises three clinical trials aimed at supporting regulatory approval for the treatment of pre-cirrhotic MASH and compensated cirrhosis due to MASH.

“MASH destroys lives silently - and efruxifermin has the potential to change that by reversing liver damage. 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,” said Mike Doustdar, President and CEO of Novo Nordisk.

“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,” he added.

Martin Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk, stated that efruxifermin complements the company’s leading portfolio.

“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,” he added.

Under the terms of the agreement, Novo Nordisk will acquire all outstanding shares of Akero’s common stock for USD 54 per share in cash, representing an aggregate value of approximately USD 4.7 billion at closing. Additionally, Akero shareholders will receive a non-transferable contingent value right (CVR), entitling them to a potential additional cash payment of USD 6 per share (approximately USD 0.5 billion in aggregate) upon US regulatory approval of EFX for the treatment of compensated cirrhosis due to MASH.

The transaction is expected to close around the turn of the year, subject to customary closing conditions, including regulatory approvals. It is not expected to affect Novo Nordisk’s previously communicated operating profit outlook for 2025. However, the free cash flow outlook for 2025 is expected to be negatively impacted by roughly USD 4 billion, reflecting the anticipated enterprise value at closing, resulting in an implied 2025 free cash flow of DKK 9–19 billion, depending on the timing of closing.

For 2026, the acquisition is expected to increase research and development costs, with an estimated negative impact on full-year operating profit growth of around 3 percentage points, depending on the closing date. The transaction will be primarily debt-financed, the company noted.