Roche bets $2.4B on potential MASH breakthrough with 89bio buy

Roche is acquiring 89bio in a $2.4B deal to gain access to its experimental liver disease drug, pegozafermin, currently in late-stage trials for MASH.

Why it matters: MASH is a leading cause of liver transplants, affecting millions in the U.S. Roche sees pegozafermin as a potential best-in-class treatment, aiming to edge ahead in a fast-growing market with few approved therapies.

Backstory: MASH, formerly known as NASH, causes fat buildup and liver scarring. Drugmakers have long targeted it, but many have failed. The FDA approved its first treatment, Madrigal’s Rezdiffra, in 2024, and Novo Nordisk recently joined with its GLP-1 receptor agonist Wegovy, signaling rising momentum and regulatory openness.

Zoom in: Pegozafermin, is an FGF21 analog aimed at reducing liver fat, inflammation, and scarring, and has already shown strong anti-inflammatory and anti-fibrotic effects in earlier studies.

Yes, but: Novartis discontinued its own FGF21 program earlier in 2024 after underwhelming trial data, but analysts argue 89bio’s differentiated approach may give it an edge over other FGF21 analogs.

Big picture: The FGF21 field is heating up, with Akero reporting fibrosis improvement, while GSK joined the race with the acquisition of Boston Pharmaceuticals’ drug this May. Roche's acquisition positions it to dominate a lucrative therapeutic space, with analysts expecting peak annual sales for pegozafermin to hit $2.1B.

What´s next: The future for the pegozafermin will depend on the quality of the phase 3 results that are expected in 2027-2028.