Roche signs merger agreement to acquire 89bio and its phase 3 FGF21 analogue for moderate to severe MASH
Thursday, September 18, 2025
Roche has entered into a definitive merger agreement to acquire 89bio, Inc., a Nasdaq-listed clinical-stage biopharmaceutical company developing therapies for liver and cardiometabolic diseases. The deal is expected to close in the fourth quarter of 2025.
89bio’s lead candidate, pegozafermin, is a fibroblast growth factor 21 (FGF21) analogue in late-stage development for patients with moderate to severe metabolic dysfunction-associated steatohepatitis (MASH) and associated liver fibrosis (F2/F3), as well as cirrhotic MASH (F4).
The acquisition strengthens Roche’s activities in cardiovascular, renal, and metabolic diseases (CVRM). Pegozafermin’s anti-fibrotic and anti-inflammatory mechanism is designed to improve efficacy and tolerability in MASH while offering potential for future combinations with incretins, creating synergies with Roche’s existing CVRM pipeline.
Pegozafermin is a glycoPEGylated analogue of FGF21 that has shown a favourable safety profile in clinical studies. It is being developed to address significant unmet needs in MASH, with the potential to provide best-in-disease efficacy across moderate to severe fibrosis and cirrhotic stages.
Following the completion of the transaction, 89bio employees will join the Roche Group as part of its Pharmaceuticals Division.
Source: globenewswire.com
