Novo Nordisk Acquires Akero Therapeutics for $4.7 Billion, Expanding Its MASH Portfolio with First-in-Class FGF21 Analogue

Novo Nordisk, has taken a significant step in expanding its innovative portfolio by announcing the acquisition of Akero Therapeutics, a clinical-stage company specializing in treatments for serious metabolic diseases. This deal, valued at approximately $4.7 billion cash with a potential additional $0.5 billion pending regulatory approval, aims to enhance Novo Nordisk’s pipeline for metabolic dysfunction-associated steatohepatitis (MASH), one of the most rapidly growing obesity-related comorbidities worldwide.

Strategic Expansion into MASH Therapies

MASH, formerly known as NASH, is a progressive liver condition linked with obesity and type 2 diabetes. With over 250 million people affected globally and few approved therapies available, the disease is projected to double in advanced-stage cases by 2030, making it a leading cause of liver transplants and cancer in Western populations.

Recognizing both the high unmet medical need and its strategic alignment with Novo Nordisk’s expertise in diabetes and obesity, the company has acquired Akero’s lead asset, efruxifermin (EFX)—an FGF21 analogue. EFX is currently in phase 3 trials and is distinguished as the only drug candidate to demonstrate significant regression of liver fibrosis in patients with compensated cirrhosis (F4) during phase 2 studies. This puts Novo Nordisk in pole position to potentially offer the first-and-best-in-class therapy for mid- to late-stage MASH.

Clinical Promise: Efruxifermin’s Groundbreaking Results

Efruxifermin is being evaluated in the SYNCHRONY clinical program, which encompasses three pivotal phase 3 trials across approximately 3,500 participants. These studies target biopsy-confirmed pre-cirrhotic MASH (F2-F3), compensated cirrhosis (F4), and real-world MASLD (metabolic dysfunction-associated steatotic liver disease).

Key Results: The HARMONY (F2-F3) and SYMMETRY (F4) phase 2b trials for EFX demonstrated remarkable improvements:

• 49% fibrosis reduction in F2-F3 patients (compared to 19% for placebo)

• 29% fibrosis regression in F4 (cirrhosis) patients vs 11% for placebo

Importantly, these results were achieved without worsening MASH, making EFX a potentially transformative solution for reversing liver damage at even advanced stages.

Transaction Terms and Financial Impacts

Deal Details: Each Akero share will be acquired for $54 in cash, accompanied by a non-transferable Contingent Value Right (CVR) of $6 pending FDA approval specifically for the F4 cirrhosis indication.

Novo Nordisk expects minimal impact on its operating profit for 2025, with free cash flow projections temporarily reduced by ~$4 billion. In 2026, research and development costs are expected to rise, affecting profit growth by roughly 3 percentage points.

Why Efruxifermin and Akero?

EFX not only reverses fibrosis but also improves non-invasive markers of liver injury, insulin sensitivity, and lipid profiles—key factors in reducing cardiovascular risk, the leading cause of death in MASH. Its once-weekly subcutaneous dosing makes it practical for wide patient adoption.