Roche To Acquire 89bio, Expanding Late-Stage MASH Pipeline With Pegozafermin

Roche, announced today that it has entered into a definitive merger agreement to acquire 89bio, Inc., a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardiometabolic diseases.

Through the acquisition, Roche will gain 89bio’s lead asset, pegozafermin, a glycoPEGylated fibroblast growth factor 21 (FGF21) analog currently in late-stage development for metabolic dysfunction-associated steatohepatitis (MASH) in patients with moderate and severe fibrosis (F2/F3) as well as cirrhosis (F4). The transaction is expected to close in the fourth quarter of 2025, subject to customary closing conditions.

“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,” said Thomas Schinecker, Roche Group CEO. 

The acquisition highlights Roche’s commitment to expanding its cardiovascular, renal, and metabolic disease (CVRM) pipeline, an area of increasing global unmet need. Pegozafermin’s anti-fibrotic and anti-inflammatory mechanism of action has demonstrated a favorable safety profile and strong potential to achieve best-in-disease efficacy. Roche sees further opportunity in combination development with incretins, leveraging synergies across its CVRM portfolio to address obesity-related and metabolic diseases.

By integrating 89bio’s programs, Roche strengthens its strategy to build a differentiated and innovative pipeline that goes beyond traditional treatment approaches, targeting the root causes of cardiometabolic and liver disease.