Novo Nordisk To Acquire Akero Therapeutics, Expanding Leadership In Metabolic And Liver Disease Treatments

Novo Nordisk today announced a definitive agreement to acquire Akero Therapeutics, Inc., a clinical-stage biotechnology company advancing therapies for serious metabolic diseases with high unmet medical needs. The deal strengthens Novo Nordisk’s position in metabolic and liver disorders, adding Akero’s fibroblast growth factor 21 (FGF21) analogue efruxifermin (EFX), a potentially best-in-class therapy for metabolic dysfunction-associated steatohepatitis (MASH), to its growing portfolio.

EFX is currently in Phase 3 development for the treatment of patients with moderate to advanced liver fibrosis (F2–F3) and those with cirrhosis (F4). The program includes three late-stage trials under the SYNCHRONY umbrella, designed to support regulatory approval for both pre-cirrhotic and cirrhotic MASH populations.

“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.”

The acquisition aligns with Novo Nordisk’s long-term strategic focus on advancing innovative, differentiated medicines that target diabetes, obesity, and associated comorbidities. Notably, more than 40% of patients with MASH also have type 2 diabetes, and over 80% are overweight or living with obesity, positioning MASH as a key therapeutic area within Novo Nordisk’s metabolic disease expertise.

Results from Akero’s Phase 2b trials — HARMONY (F2–F3) and SYMMETRY (F4) — demonstrated clinically meaningful fibrosis improvement and reversal of compensated cirrhosis due to MASH. Over 96 weeks, fibrosis improvement without worsening of MASH was observed in 49% of patients in HARMONY and 29% in SYMMETRY, compared to 19% and 11% in placebo groups, respectively. EFX remains the only candidate to show 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.”

Under the agreement, Novo Nordisk will acquire all outstanding shares of Akero’s common stock for $54 per share in cash, representing a total equity value of approximately $4.7 billion. Akero shareholders will also receive a contingent value right (CVR) of up to $6 per share in cash (approximately $0.5 billion total), payable upon U.S. FDA approval of EFX for compensated cirrhosis due to MASH.

The transaction, unanimously approved by Akero’s Board of Directors, is expected to close around the turn of the year, pending customary regulatory and shareholder approvals. Novo Nordisk is being advised by BofA Securities (financial) and Ropes & Gray LLP (legal).