89bio is a clinical-stage biopharmaceutical company with no approved products and no revenue. Its entire pipeline centers on a single drug candidate, pegozafermin, an engineered analog of FGF21 — a natural metabolic hormone that regulates fat metabolism, reduces liver fat and inflammation, improves insulin sensitivity, and targets fibrosis pathways. 89bio has engineered pegozafermin using proprietary glycoPEGylation technology to extend the molecule's half-life and enable once-weekly or every-two-week subcutaneous self-injection. Pegozafermin is being developed for two indications: MASH (metabolic dysfunction-associated steatohepatitis), a severe progressive liver disease linked to obesity and metabolic conditions, and SHTG (severe hypertriglyceridemia), a condition defined by triglyceride levels above 500 mg/dL that raises risk of pancreatitis and cardiovascular events. In MASH, Phase 2b results showed statistically significant improvements on both FDA-required histology endpoints, and two Phase 3 trials are now enrolling, with topline data expected in 2027 and 2028. The FDA granted Breakthrough Therapy designation and the EMA granted PRIME designation. In SHTG, a Phase 3 trial completed enrollment in late 2024, with topline data expected in Q1 2026. 89bio is pre-revenue and funded entirely by capital raises, spending primarily on clinical trials and outsourced drug manufacturing. If approved, pegozafermin would be sold through specialty pharmacy channels, with tiered royalties owed to Teva under a licensing agreement.