Roche Enters MASH Market with $3.5B Acquisition of 89bio
Roche has made a significant move into the metabolic dysfunction-associated steatohepatitis (MASH) market by agreeing to acquire 89bio for up to $3.5 billion. The deal, announced on September 18, 2025, centers around pegozafermin, 89bio's FGF21 analog currently in late-stage development for MASH.
Deal Structure and Financial Details
Roche will pay $14.50 per share in cash for 89bio, representing a 79% premium to the biotech's closing price on September 17. The deal includes a contingent value right (CVR) of up to $6 per share, tied to specific milestones related to pegozafermin's commercialization and sales targets. The total equity value of the acquisition could reach $3.5 billion if all CVR conditions are met.
The upfront payment values 89bio at $2.4 billion, with the potential for an additional $1.1 billion through the CVR. The acquisition is expected to close in the fourth quarter of 2025, subject to customary closing conditions.
Pegozafermin: A Promising MASH Candidate
Pegozafermin, an FGF21 analog, is the centerpiece of the acquisition. The drug is currently in Phase 3 trials for MASH in patients with moderate to severe fibrosis and cirrhosis. Key features of pegozafermin include:
- Potential for "best-in-disease efficacy" for moderate to severe MASH patients, according to Roche CEO Thomas Schinecker
- Combined anti-fibrotic and anti-inflammatory mechanism of action
- Promising Phase 2b results showing reduced liver scarring in MASH patients
- Ongoing Phase 3 ENLIGHTEN-Fibrosis study, with results expected in the first half of 2027
In the Phase 2b ENLIVEN study, 27% of patients treated with 44-mg pegozafermin twice weekly achieved at least a one-stage improvement in fibrosis without worsening of MASH, compared to 7% in the placebo group. Additionally, 26% of pegozafermin-treated patients experienced resolution of MASH without worsening of fibrosis, versus 2% in the placebo group.
Competitive Landscape in MASH Treatment
The acquisition positions Roche as a significant player in the increasingly competitive MASH market. Recent developments in this space include:
- Madrigal Pharmaceuticals' Rezdiffra: Approved in March 2024 as the first MASH-specific treatment in the U.S.
- Novo Nordisk's Wegovy: Received regulatory clearance for MASH treatment in August 2025
- Akero Therapeutics: Developing efruxifermin, another FGF21 analog with promising Phase 2b results
- GSK: Entered the MASH space through an acquisition in May 2025
The MASH market is considered large enough to accommodate multiple treatment options, with millions of patients affected in the U.S. alone. The FDA's consideration of using noninvasive liver measurements as surrogate endpoints for certain MASH patients could potentially accelerate drug development in this area.
References
- Roche Makes Major MASH Move With $3.5B 89bio Buy
The star of the acquisition, which includes a contingent value right of $6 per share, is pegozafermin, an FGF21 analog in late-stage development for metabolic dysfunction-associated steatohepatitis.
- Roche dives into MASH with $2.4B deal for 89bio
Roche’s CEO claimed 89bio’s drug, which is in late-stage testing, has the potential to show “best-in-disease efficacy” for many people with the condition.
- Roche becomes MASH player via $3.5B deal for 89bio and its phase 3 drug
Roche dived into the metabolic dysfunction-associated steatohepatitis space by agreeing to hand over up to $3.5 billion for 89bio and its phase-3-stage candidate.
Explore Further
What are the key milestones linked to the contingent value rights (CVR) in Roche's acquisition of 89bio?
What are the specific strengths of pegozafermin compared to Madrigal Pharmaceuticals' Rezdiffra and Novo Nordisk's Wegovy?
How might Roche leverage its existing infrastructure to accelerate the commercialization of pegozafermin if approved?
What is the estimated market size and growth potential for MASH treatments in the U.S. and globally?
Are there any recent trends or synergies in the pharmaceutical industry regarding acquisitions targeting FGF21 analogs or similar metabolic treatments?