Roche pays $3.5bn for 89bio and its potential best-in-disease treatment MASH drug

Roche is set to gain rights to a potential best-in-disease metabolic dysfunction-associated steatohepatitis (MASH) treatment by acquiring the US-based biopharma 89bio for up to $3.5 billion.

Pegozafermin’s combined anti-fibrotic and anti-inflammatory mechanism could offer a new option for moderate to severe MASH patients (liver fibrosis (F2/F3 stages) and cirrhotic MASH (F4 stage).

Thomas Schinecker, Roche Group CEO, said: “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.”

89bio’s pegozafermin is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21) analog and currently in Phase III clinical trials for the disease.

Its GlycoPEGylation technology increases the half-life of native FGF21, enabling either weekly or every-other-week dosing.

Rohan Palekar, Chief Executive Officer of 89bio, said: “Our mission at 89bio has always been to develop innovative therapies to help patients with serious liver and cardiometabolic diseases, a commitment demonstrated by the strategic design and successful execution of the development program for pegozafermin over the years.

“We are thrilled to be joining with Roche to combine the promise of pegozafermin with Roche’s established global development, manufacturing, and commercialisation capabilities.”

MASH is formerly known as nonalcoholic fatty liver disease (NAFLD) and an estimated five to seven percent of adults are affected by it, Roche stated. “More than 75 percent of those living with the condition experience comorbidities such as overweight, obesity, and type 2 diabetes,” based on research from 2024. 

The deal is expected to close in Q4 of 2025, when all of 89bio’s current employees will join the Roche Group as part of its Pharmaceuticals Division.