The pharmaceutical industry has seen a shift in the landscape for metabolic dysfunction-associated steatohepatitis (MASH) treatments following the approval of Madrigal Pharmaceuticals’ Rezdiffra in 2024. The drug’s commercial performance, with $287 million in revenue reported just six quarters after launch and a total of $817 million to date, has sparked significant interest from larger pharmaceutical companies.
In 2025, this attention led to several major acquisitions focused on FGF21 analogs. GSK acquired efimosfermin alfa from Boston Pharmaceuticals for $1.2 billion upfront in May. Roche followed by purchasing 89bio and its FGF21 analog pegozafermin for about $3.5 billion in September. Shortly afterward, Novo Nordisk completed a $5.2 billion deal for Akero Therapeutics. These moves were influenced by positive mid-stage trial data from Akero’s efruxifermin earlier that year.
Edward Nash, managing director at Canaccord Genuity, commented on this trend: “I think that really set off the stampede because there were very few FGF21 assets in development,” he told BioSpace. “This caused a big pharma reaction of, ‘Wait a minute, we need one of those too because we have a metabolic franchise and we need to be able to compete, especially given the data seen to date in the FGF21 space.’”
Nash also noted that the market is expanding further due to the approval of Novo Nordisk’s GLP-1 drug Wegovy for MASH treatment.
With key FGF21 developers now acquired, focus has shifted to other late-stage candidates:
Inventiva is advancing lanifibranor, an oral pan-PPAR agonist targeting three peroxisome proliferator-activated receptor isoforms to address multiple aspects of MASH pathology. The company expects topline results from its Phase III NATiV3 trial in late 2026. CEO Frederic Cren stated in April 2025: “lanifibranor could potentially be the next oral therapy approved for the treatment of patients with MASH.” In previous trials, lanifibranor showed statistically significant improvements in both MASH resolution and fibrosis.
Viking Therapeutics is developing VK2809, an oral thyroid hormone receptor-beta agonist. Data from its Phase IIb VOYAGE trial indicated substantial reductions in liver fat and high rates of MASH resolution without worsening fibrosis as of November 2024. CEO Brian Lian said via email: “The overall body of evidence for VK2809 makes it ‘highly competitive’ against both marketed products and drug candidates for MASH.” Viking remains open to partnership opportunities but does not require one to bring VK2809 to market.
Altimmune’s pemvidutide stands out due to its preservation of lean muscle mass alongside weight loss and MASH resolution benefits. The weekly injectable GLP-1/glucagon dual receptor agonist recently received FDA Breakthrough Therapy Designation after Phase IIb data showed more than half of patients achieved MASH resolution without fibrosis worsening. A company spokesperson said via email that bringing pemvidutide forward independently is a “legitimate path forward,” though partnerships remain under consideration.
Sagimet Biosciences is pursuing denifanstat, an oral fatty acid synthase inhibitor that blocks new fat production in the liver and also holds FDA Breakthrough Therapy Designation for MASH. Sagimet plans further studies pairing denifanstat with Rezdiffra after initial combination data suggested good tolerability and potential added benefit over monotherapy.
According to Nash, combination approaches may represent the future direction for treating this multifactorial disease: “There’s usually only one company when that happens, like Madrigal. I think we’re going to have one, maybe two biotechs, that can do it—after that, it’s going to be Big Pharma taking them in and developing them.”
Overall, smaller biotech firms are likely acquisition targets or will seek partnerships as competition intensifies within this evolving therapeutic area.
