Roche dived into the metabolic dysfunction-associated steatohepatitis (MASH) space by agreeing to hand over up to $3.5 billion for 89bio and its phase-3-stage candidate for the fatty liver disease.<\/p>\n
At the center of the deal is pegozafermin, an FGF21 analog in late-stage trials for MASH in moderate and severe fibrotic patients as well as those with cirrhosis of the liver. 89bio is expecting a readout from the phase 3 MASH trial in the first half of 2027, but Roche has seen enough to know it wants pegozafermin in its own pipeline.<\/p>\n
The Swiss pharma is paying $14.50 per share in cash\u00a0for the San Francisco-based biotech\u2014a 79% increase on the company\u2019s $8.08 closing price yesterday\u2014with 89bio\u2019s stockholders also set to receive a contingent value right up to a limit of $6 per share tied to certain milestones.<\/p>\n
The specific milestones relate to commercial goals, such as the first sale of pegozafermin in F4 MASH cirrhotic patients, as long as it occurs before March 31, 2030.<\/p>\n
Taken together, the offering equates to a total equity value of up to about $3.5 billion for 89bio, Roche explained in a Sept. 18 release<\/a>. As part of the deal\u2014which is due to complete in the fourth quarter\u201489bio\u2019s employees will join Roche as part of the drugmaker\u2019s pharmaceuticals division.<\/p>\n \u201cThis acquisition further strengthens our portfolio in cardiovascular, renal, and metabolic diseases and offers opportunities to explore combinations with existing programmes in our pipeline,\u201d Roche Group CEO Thomas Schinecker said in the release.<\/p>\n \u201cWe are highly encouraged by pegozafermin\u2019s potential to become a transformative treatment option in MASH, one of the most prevalent comorbidities of obesity, and to meet diverse patient needs associated with this complex disease,\u201d Schinecker added. \u201cWith its combined anti-fibrotic and anti-inflammatory mechanism, pegozafermin could potentially offer best-in-disease efficacy for all moderate to severe MASH patients.\u201d<\/p>\n Interest in pegozafermin began to grow back in 2023, when 89bio posted results<\/a> from a phase 2b study that linked the FGF21 analog to reduced liver scarring in patients with MASH.<\/p>\n Akero Therapeutics provided early validation of the idea of using FGF21 analogs to treat MASH back in 2022 as part of a phase 2b data drop that\u00a0demonstrated<\/a>\u00a0its once-weekly candidate, efruxifermin, could reduce fibrosis. Efruxifermin went on to miss its primary endpoint the following year, before redeeming itself<\/a> in January 2025 with statistically significant results in two key 96-week MASH analyses.<\/p>\n MASH may be a notoriously tricky indication, but that hasn\u2019t stopped the space from heating up in recent years. Madrigal Pharmaceuticals made history in 2024 when the FDA\u00a0approved<\/a>\u00a0its medicine Rezdiffra as the first MASH drug in the U.S., while Novo Nordisk saw its blockbuster weight loss drug Wegovy approved<\/a> for the fatty liver disease last month.<\/p>\n Despite Madrigal\u2019s first-mover advantage in MASH, \u201cthis is a large market with room for many players and treatment options,\u201d analysts at Evercore ISI wrote last year following Novo\u2019s data drop for semaglutide in the disease.<\/p>\n