Novo Nordisk to Acquire Akero Therapeutics to Strengthen MASH Pipeline with Phase 3 FGF21 Analogue Efruxifermin
Novo Nordisk, a global healthcare leader in diabetes and obesity treatments, has announced a definitive agreement to acquire Akero Therapeutics, Inc., a publicly traded, clinical-stage biotechnology company focused on developing innovative therapies for serious metabolic diseases. This strategic acquisition marks a major step forward in Novo Nordisk’s ambition to expand its presence in metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease that is rapidly emerging as a global health challenge.
At the heart of this acquisition is Akero’s lead candidate, efruxifermin (EFX) — a fibroblast growth factor 21 (FGF21) analogue that has demonstrated the potential to reverse liver fibrosis and improve liver health in patients with MASH. The candidate is currently in phase 3 clinical development for treating individuals with moderate to advanced liver fibrosis (F2–F3) and those with cirrhosis (F4).
Strategic and Portfolio Synergy
The acquisition underscores Novo Nordisk’s long-term strategy of advancing innovative, differentiated therapies that target interconnected metabolic diseases — particularly diabetes, obesity, and their associated comorbidities. The company has consistently sought to broaden its reach in treating conditions that share underlying metabolic dysfunction, and MASH represents a critical next frontier in that vision.
The relationship between MASH, obesity, and diabetes is well established. It is estimated that over 40% of individuals with MASH also have type 2 diabetes, and more than 80% are overweight or living with obesity. This overlap makes MASH a natural extension of Novo Nordisk’s therapeutic expertise.
“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, either as a standalone or in combination with Wegovy® (semaglutide), to address 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 leadership in diabetes, obesity, and their associated comorbidities.”
Efruxifermin (EFX): A Potential Best-in-Class Therapy for MASH
Efruxifermin (EFX) is a long-acting analogue of fibroblast growth factor 21 (FGF21), a naturally occurring hormone that regulates glucose and lipid metabolism and has shown therapeutic promise in treating metabolic disorders.
The candidate is currently being investigated in the phase 3 SYNCHRONY program, which consists of three late-stage clinical trials designed to support regulatory approval for the treatment of pre-cirrhotic (F2–F3) MASH and compensated cirrhosis (F4) caused by MASH.
The phase 3 program builds on two successful 96-week phase 2b trials — HARMONY (F2–F3) and SYMMETRY (F4) — in which EFX demonstrated statistically significant improvements in liver fibrosis and reversal of disease progression.
In these studies:
- In the HARMONY trial (patients with F2–F3 fibrosis), 49% of patients treated with EFX achieved fibrosis reduction without worsening of MASH, compared to 19% in the placebo group.
- In the SYMMETRY trial (patients with F4 cirrhosis), 29% of patients achieved fibrosis improvement without worsening of MASH, compared to 11% in the placebo arm.
Remarkably, EFX is the only treatment to have demonstrated significant fibrosis regression in F4 patients in a phase 2 trial — a milestone achievement that signals its potential to redefine therapeutic standards in advanced liver disease.
According to Martin Lange, Chief Scientific Officer and Executive Vice President of Research & Development at Novo Nordisk, “Efruxifermin complements Novo Nordisk’s leading metabolic portfolio and aligns with our goal of offering competitive treatment options across all stages of MASH. Within MASH, there remains an enormous unmet need, especially for patients in later disease stages where current treatment options are extremely limited.”
He added, “Based on the strong data generated by Akero, we believe efruxifermin could emerge as a first- and best-in-class therapy for mid- to late-stage MASH with the potential to reverse liver damage. Novo Nordisk is uniquely positioned to unlock the full clinical and commercial potential of efruxifermin and reach more patients worldwide.”
Transaction Terms and Structure
Under the terms of the agreement, Novo Nordisk will acquire all outstanding shares of Akero Therapeutics’ common stock for $54 per share in cash, valuing the deal at approximately $4.7 billion at closing.
Additionally, Akero shareholders will be eligible to receive a non-transferable contingent value right (CVR), which could provide an additional payment of $6 per share (equivalent to about $500 million) in cash upon U.S. regulatory approval of EFX for the treatment of compensated cirrhosis (F4) 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, subject to customary closing conditions, including approval by relevant regulatory authorities.
Novo Nordisk is being advised by BofA Securities as financial advisor and Ropes & Gray LLP as legal counsel.
Financial Outlook and Impact
Novo Nordisk emphasized that the acquisition will not affect its previously communicated operating profit outlook for 2025. However, the company expects its free cash flow for 2025 to be negatively impacted by approximately $4 billion, reflecting the enterprise value at the time of closing. Consequently, Novo Nordisk’s implied 2025 free cash flow outlook will range between 9 billion and 19 billion DKK, depending on the timing of the deal’s completion.
Looking ahead to 2026, Novo Nordisk anticipates a temporary increase in research and development (R&D) expenses associated with integrating Akero’s ongoing programs. This is expected to result in an estimated 3 percentage point negative impact on full-year operating profit growth in 2026. The acquisition will be primarily debt-financed, reinforcing Novo Nordisk’s strong balance sheet flexibility and commitment to long-term growth investments.
The Broader Context: Novo Nordisk’s Expanding Metabolic Portfolio
The acquisition of Akero Therapeutics comes at a time when Novo Nordisk is rapidly expanding its presence beyond diabetes and obesity to address a broader range of metabolic diseases. The company’s success with GLP-1 receptor agonists such as Ozempic® and Wegovy® has transformed it into a global leader in metabolic health, positioning it to tackle related conditions such as cardiovascular disease, chronic kidney disease, and MASH.
MASH, previously known as nonalcoholic steatohepatitis (NASH), is a progressive liver disease caused by fat accumulation and inflammation, leading to fibrosis, cirrhosis, and potentially liver failure. With rising obesity and diabetes prevalence worldwide, MASH is projected to become the leading cause of liver transplantation within the next decade. Yet, despite its growing burden, no drug is currently approved to treat MASH, leaving a large unmet medical need.
By acquiring Akero and its lead FGF21 analogue, Novo Nordisk not only gains a potentially transformative therapy but also strengthens its competitive edge in the next generation of metabolic therapies. Efruxifermin’s once-weekly dosing regimen and disease-modifying potential could make it a natural complement to Novo Nordisk’s existing GLP-1-based therapies, offering multi-pronged treatment options to address obesity-driven liver disease.
Conference Call and Next Steps
Novo Nordisk will host a conference call for investors on October 9, 2025, at 14:00 CEST (8:00 a.m. EDT) to discuss the details of the transaction, the clinical development plans for EFX, and the strategic rationale behind the acquisition. A link for investors to join the call will be made available on the Investor Relations section of novonordisk.com.
The acquisition of Akero Therapeutics represents a bold and strategic move by Novo Nordisk to expand its leadership in metabolic disease management. By integrating efruxifermin into its robust portfolio, Novo Nordisk aims to advance the first potential disease-reversing therapy for MASH, addressing one of the fastest-growing and most underdiagnosed metabolic conditions globally.
With its proven expertise in developing and commercializing metabolic therapies, Novo Nordisk is well positioned to accelerate efruxifermin’s journey from clinical trials to global market access, bringing hope to millions of patients worldwide who currently have no effective treatment options.
This acquisition not only reinforces Novo Nordisk’s dominance in diabetes and obesity care but also sets the stage for the company to become a global leader in liver and metabolic health innovation — fulfilling its mission to improve lives through science-driven medicine.
