Novo Nordisk can attain MASH sufferers with the current FDA determination increasing approval of its GLP-1 drug Wegovy to the remedy of moderate-to-advanced instances of the fatty liver illness. Now it’s buying Akero Therapeutics in a multi-billion-dollar deal that brings a late-stage drug candidate with the potential to assist sufferers in probably the most extreme stage of MASH.
In response to deal phrases introduced Thursday, Novo Nordisk pays $54 in money for every Akero share, valuing the biotech at $4.7 billion. A contingent worth proper within the deal makes the Danish pharmaceutical big chargeable for paying an extra $6 in money per share upon FDA approval of Akero’s drug, efruxifermin, for the remedy of compensated cirrhosis as a consequence of MASH. Attaining that purpose would add one other $500 million to the payout.
Talking throughout a Thursday convention name, Novo Nordisk CEO Mike Doustdar famous that the Akero deal is the biggest R&D acquisition within the historical past of the corporate. It’s additionally the primary one since he took over as chief government in August.
“Whereas many exterior elements are difficult us on a day after day foundation, a part of my job is to make sure the progress of our long-term aspiration of insuring management in diabetes and weight problems and their associated comorbidities,” Doustdar stated. “We are able to solely try this by elevating the innovation bar to convey progressive medicines to the market, and thus, affect thousands and thousands of sufferers worldwide. At the moment’s acquisition additional strengthens the likelihood to take action.”
MASH, brief for metabolic dysfunction-associated steatohepatitis, develops as fats builds up within the liver, resulting in irritation and the formation of scar tissue. The extent of this liver scarring, known as fibrosis, is measured in response to a scale starting from F0, representing no fibrosis, to F4, which is cirrhosis. In response to the FDA, about 14.9 million Individuals have MASH. Globally, Novo Nordisk estimates the illness impacts greater than 250 million folks.
Akero’s efruxifermin is a protein engineered to be a protracted -analog for fibroblast progress issue 21 (FGF21), a liver-secreted hormone that regulates vitality expenditure and metabolization of fats. The half-life of native FGF21 is lower than two hours. South San Francisco-based Akero engineered efruxifermin with a half-life lasting days, enabling once-weekly dosing of the injectable drug. In early 2025, Akero reported Section 2 outcomes exhibiting remedy with efruxifermin over 96 weeks achieved a statistically vital reversal of cirrhosis with no worsening of MASH. Up to now, efruxifermin is the one drug to point out this stage of impact in sufferers with F4 fibrosis.
Novo Nordisk’s Wegovy, which works by activating the GLP-1 receptor, added MASH to its label in August. That FDA determination solely covers MASH sufferers with F2 and F3 fibrosis. The corporate says there’s nonetheless an unmet medical want. Along with the untreated inhabitants of F4 sufferers, a few of these with moderate-to-severe illness might not reply to a GLP-1 drug, the corporate stated in an investor presentation.
MASH was as soon as a graveyard for drug analysis, however that’s modified in recent times. In 2024, Madrigal Prescription drugs landed the primary approval in MASH for Rezdiffra, an oral small molecule designed to activate THR-beta, a receptor that mediates metabolic exercise within the liver. Rezdiffera’s accelerated approval covers the remedy of moderate-to-advanced MASH.
The Akero acquisition settlement comes three weeks after Roche introduced a deal to purchase 89bio and its late-stage MASH drug for $2.4 billion. Like Akero’s drug, 89bio’s pegozafermin is a protein engineered to imitate FGF21. Made with expertise giving the drug an extended half-life, the every-two-weeks injection would presents a sufferers a dosing benefit in comparison with weekly injections of Akero’s drug. Two Section 3 exams of the 89bio drug are ongoing. In the meantime, GSK has mid-stage drug candidate efimosfermin, which it acquired earlier this 12 months in a $1.2 billion cope with Boston Prescription drugs. This FGF21 analog’s longer half-life is meant to help once-monthly dosing.
In a be aware despatched to traders, Leerink Companions analyst Thomas Smith identified the Akero deal marks the third MASH-related acquisition this 12 months — all for FGF21-targeted belongings. These transactions reinforce Leerink’s view that this drug class is likely one of the most compelling for addressing fibrosis in MASH. Smith added that the Akero acquisition comes two months after Novo discontinued its inner FGF21 program as a consequence of a failed Section 2 research, underscoring that not all FGF21 analogs are equal. Whereas Leerink expects the deal will shut, Smith stated there could also be some Federal Commerce Fee scrutiny given the pipeline overlap of the businesses. There may additionally be political scrutiny.
Of the three FGF21 MASH drug acquisitions this 12 months, the Akero deal is the most important. Martin Holst Lange, government vice chairman, R&D, and chief scientific officer, stated the premium Novo Nordisk is paying is justified. Simply as Novo Nordisk sees variations throughout the GLP-1 house, it sees variations in FGF21 medicine, he stated. Efruxifermin was not solely totally different from Novo’s internally developed FGF21 drug candidate, it has proven superior efficacy and probably higher security and tolerability in contrast different FGF21 medicine up to now.
“So we imagine that with this acquisition we not solely have wholesome potential to be greatest at school, but in addition, and that is clearly a timing perspective, first at school as a result of it’s a extra progressed program,” Lange stated.
Three Section 3 research are underway for efruxifermin with a complete enrollment of roughly 3,500 members. The primary readout, from a real-world research, is anticipated as early as subsequent 12 months with the opposite research yielding knowledge in years to return. Within the meantime, Lange stated the corporate plans to discover potential combos of efruxifermin with its GLP-1 drug portfolio. The corporate may even examine purposes of the Akero drug in different indications.
The $54 per share value Novo is paying for Akero is only a 16% premium to the inventory’s Wednesday closing value, but it surely’s a 42% premium to Akero’s closing value on Could 19 earlier than hypothesis emerged about an acquisition. The phrases of the contingent worth proper require efruxifermin to safe FDA approval by June 30, 2031.
The acquisition has been permitted by Akero’s board of administrators however nonetheless wants shareholder and regulatory approvals. The businesses anticipate to finish the transaction by the tip of this 12 months.
Photograph: Liselotte Sabroe/Scanpix Denmark/AFP, through Getty Photos
