Roche's MASH Drug Candidate Pegozafemin Designated for Breakthrough Therapy Status

Stock News05-25

On May 25th, the Center for Drug Evaluation (CDE) website indicated that Pegozafermin, developed by Roche Holding Ltd (RHHBY.US), is proposed for inclusion in the breakthrough therapy designation program for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Pegozafermin is an FGF21 analog developed by 89bio, exhibiting both anti-fibrotic and anti-inflammatory effects. In September 2025, Roche acquired 89bio in a total transaction valued at $3.5 billion, securing all rights to this drug. Results from the Phase II ENLIVEN study showed that among MASH patients with stage 2 or 3 fibrosis, a higher proportion of patients in the Pegozafermin groups achieved at least a one-stage improvement in fibrosis without worsening of MASH, compared to the placebo group. Specifically, the proportions achieving this endpoint in the 15 mg, 30 mg, 44 mg, and placebo groups were 22%, 26%, 27%, and 7%, respectively. Furthermore, the proportions of patients achieving MASH resolution in the 15 mg, 30 mg, 44 mg, and placebo groups were 37%, 23%, 26%, and 2%, respectively.

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