Roche to Acquire 89bio in $3.5 Billion Deal Bolstering its MASH Pipeline
The definitive merger agreement, valued at up to $3.5 billion, grants Roche control of the late-stage FGF21 analog, pegozafermin, for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH).
In a major strategic move to expand its cardiovascular, renal, and metabolic diseases (CVRM) portfolio, Roche has entered into a definitive merger agreement to acquire 89bio, Inc., a clinical-stage biopharmaceutical company. The central asset in the acquisition is 89bio’s lead candidate, pegozafermin, a potentially best-in-disease glycoPEGylated analog of fibroblast growth factor 21 (FGF21) currently in Phase 3 development for moderate to severe Metabolic Dysfunction-Associated Steatohepatitis (MASH).
The transaction, announced September 18, 2025, underscores the high value placed on effective MASH therapies and Roche’s commitment to addressing the complex comorbidities of obesity. Under the terms of the agreement, Roche will acquire 89bio for US$14.50 per share in cash at closing, representing a total equity value of approximately US$2.4 billion. Additionally, stockholders will receive a non-tradeable contingent value right (CVR) for up to an aggregate of US$6.00 per share in cash, representing a total potential deal value of up to approximately US$3.5 billion.
Strategic Rationale for the Acquisition
The acquisition of 89bio is a targeted enhancement of Roche’s CVRM portfolio, a key therapeutic area for the company. Pegozafermin’s distinct anti-fibrotic and anti-inflammatory mechanism of action not only holds the potential for enhanced efficacy and tolerability in MASH but also unlocks significant opportunities for future combination therapies with incretins, creating synergies with Roche’s existing pipeline.
Thomas Schinecker, Roche Group CEO, stated:
“This acquisition further strengthens our portfolio in cardiovascular, renal, and metabolic diseases and offers opportunities to explore combinations with existing programmes in our pipeline. We are highly encouraged by pegozafermin’s potential to become a transformative treatment option in MASH, one of the most prevalent comorbidities of obesity, and to meet diverse patient needs associated with this complex disease. With its combined anti-fibrotic and anti-inflammatory mechanism, pegozafermin could potentially offer best-in-disease efficacy for all moderate to severe MASH patients.”
Details of the Merger Agreement and Contingent Value Rights
Roche will promptly commence a tender offer to acquire all outstanding shares of 89bio common stock. The price payable at closing represents a premium of approximately 52% to 89bio’s 60-day volume-weighted average price (VWAP) on September 17, 2025. The merger agreement has been unanimously approved by the boards of directors of both Roche and 89bio.
The non-tradeable CVR entitles holders to receive contingent cash payments upon the achievement of specific commercial milestones within defined timeframes:
- US$2.00 per share upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients by March 31, 2030.
- US$1.50 per share upon pegozafermin reaching annual net sales of at least US$3.0 billion globally in any calendar year by December 31, 2033.
- US$2.50 per share upon pegozafermin reaching annual net sales of at least US$4.0 billion globally in any calendar year by December 31, 2035.
There is no assurance that any CVR payments will be made. If all conditions are met, the CVR would represent additional cash consideration of up to approximately US$1.0 billion.
The Promise of Pegozafermin in a Prevalent Disease
Pegozafermin is designed to address critical unmet needs in MASH, a serious and progressive form of fatty liver disease estimated to affect 5-7% of the world’s adult population and strongly associated with the global rise in obesity and type 2 diabetes. The drug is in Phase 3 trials for the treatment of MASH with advanced fibrosis (F2 and F3 stages) as well as for patients with compensated cirrhosis (F4 stage).
Rohan Palekar, Chief Executive Officer of 89bio, said:
“This transaction is a testament to the potential of pegozafermin to make a significant difference for patients living with MASH. With its combined anti-fibrotic and anti-inflammatory mechanism of action combined with a favourable safety profile, pegozafermin is positioned to potentially deliver best-in-disease efficacy for patients suffering from moderate to severe liver fibrosis and cirrhotic MASH. We believe that Roche is the ideal partner to maximize the potential of pegozafermin and deliver this important therapy to patients worldwide.”
Following the completion of the tender offer, Roche will acquire all remaining shares through a second-step merger. The transaction is expected to close in the fourth quarter of 2025 and is subject to customary closing conditions, including the tender of a majority of 89bio’s outstanding shares and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Current 89bio employees will join the Roche Group as part of Roche’s Pharmaceuticals Division.
For more information, visit www.89bio.com and www.roche.com.
Original Source: Press release: Basel, 18 September 2025 – Roche – Roche enters into a definitive merger agreement to acquire 89bio, and its phase 3 FGF21 analog for the therapy of moderate to severe MASH
