Novo Nordisk announced Thursday its acquisition of Akero Therapeutics in a deal worth up to $5.2 billion, securing access to efruxifermin (EFX), a leading drug candidate for treating metabolic dysfunction-associated steatohepatitis (MASH). The transaction represents a strategic expansion of Novo Nordisk's metabolic disease portfolio beyond its established GLP-1 franchise.
Deal Structure and Valuation
Under the definitive agreement, Akero shareholders will receive $54.00 per share in cash at closing, representing an equity value of approximately $4.7 billion. This upfront payment constitutes a 19% premium to Akero's 30-day volume weighted average price and a 42% premium to the company's closing price on May 19, 2025, prior to market speculation about a potential acquisition.
Additionally, shareholders will receive non-transferable Contingent Value Rights (CVRs) worth $6.00 per share if EFX achieves full U.S. regulatory approval for treatment of compensated cirrhosis due to MASH by June 30, 2031. Combined, the upfront and potential contingent payments represent a 32% premium to Akero's 30-day VWAP and a 57% premium to the May 19 closing price.
Strategic Rationale and Clinical Promise
The acquisition positions Novo Nordisk to leverage its "world leading capabilities in cardio-metabolic disease" to enhance and accelerate EFX's development through the Phase 3 SYNCHRONY program. According to Andrew Cheng, M.D., Ph.D, President and CEO of Akero Therapeutics, the transaction "delivers meaningful value to Akero shareholders, and positions us to expand treatment options for people around the globe through Novo Nordisk's industry-leading development capabilities and commercial infrastructure."
EFX has demonstrated significant clinical promise in multiple Phase 2 trials, where it has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This comprehensive therapeutic profile addresses the complex, multi-system nature of MASH across all disease stages, including improvements in cardiovascular risk factors—the leading cause of death among MASH patients.
Phase 3 Development Program
The ongoing global Phase 3 SYNCHRONY program encompasses approximately 3,500 participants across three randomized, placebo-controlled trials evaluating EFX's efficacy and safety in both compensated cirrhosis (F4) due to MASH and pre-cirrhotic (F2-F3) MASH:
- SYNCHRONY Real-World: Assessing safety and tolerability of EFX (50 mg) in patients with noninvasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD) across fibrosis stages F1-F4
- SYNCHRONY Histology: Evaluating efficacy and safety of EFX (28 mg and 50 mg) in patients with biopsy-confirmed pre-cirrhotic (F2-F3) MASH
- SYNCHRONY Outcomes: Testing efficacy and safety of EFX (50 mg) for treating compensated cirrhosis (F4) due to MASH
Drug Profile and Mechanism
Engineered to mimic the biological activity profile of native FGF21, EFX is designed for once-weekly subcutaneous dosing and has been generally well-tolerated in clinical trials to date. The drug's holistic therapeutic profile offers potential to address MASH as a complex, multi-system disease while simultaneously improving cardiovascular risk factors.
Transaction Timeline and Approvals
The transaction has received unanimous approval from Akero's Board of Directors and is expected to close around year-end, subject to Akero shareholder approval and satisfaction of customary closing conditions, including regulatory authority approvals. Morgan Stanley & Co. LLC and J.P. Morgan Securities LLC are serving as financial advisors to Akero Therapeutics, with Kirkland & Ellis LLP as legal advisor.
