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89bio, Inc. is a clinical-stage biopharmaceutical company focused on developing and delivering differentiated therapies for the treatment of liver and cardiometabolic diseases with high unmet medical need. The company’s lead product candidate, pegozafermin, is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21), a hormone involved in regulating lipid and glucose metabolism, inflammation, and fibrosis—key pathways implicated in MASH (Metabolic dysfunction-associated steatohepatitis) and MASLD (Metabolic dysfunction-associated steatotic liver disease).

Pegozafermin is being developed as a first-in-class, long-acting FGF21 analog with the potential to address the full spectrum of liver and metabolic abnormalities in patients with MASH/MASLD. It is currently being evaluated in Phase 2b and Phase 3 clinical studies aimed at demonstrating its ability to reduce liver fat, improve inflammation, and reverse fibrosis—hallmark features of MASH/MASLD progression. Early clinical data have shown promising results, including significant improvements in liver histology, lipid profiles, and insulin sensitivity, with a favorable safety and tolerability profile.

89bio’s approach is based on the belief that FGF21-based therapy offers a multi-pronged mechanism of action capable of tackling both hepatic and systemic drivers of disease. Pegozafermin’s design enables extended half-life and liver-directed activity, allowing for convenient dosing while enhancing therapeutic benefit. These attributes position pegozafermin as a potential backbone therapy in the evolving MASH/MASLD treatment landscape.

With a clear focus on innovation and impact, 89bio is committed to transforming outcomes for patients with progressive liver disease. The company’s pipeline also includes additional indications where FGF21 analogs may offer clinical benefit, further underscoring 89bio’s dedication to addressing complex metabolic disorders through precision biologic solutions.