Novo inks Akero buyout worth up to $5.2B to bag late-phase MASH prospect

Novo Nordisk has struck a deal to buy Akero Therapeutics for up to $5.2 billion, teeing up a showdown with Roche and others in a blockbuster liver disease market. 

Akero confirmed its status as a key name in the metabolic dysfunction-associated steatohepatitis (MASH) space in February, when the publication of data that an analyst hailed as “transformational” doubled its share price. 

It recently emerged that Roche responded to the data by stepping up talks with 89bio, one of Akero’s chief rivals. Roche struck its 89bio buyout last month, moving to secure the biotech's FGF21 analog pegozafermin.

Now, Novo Nordisk has agreed to buy Akero for about $4.7 billion upfront. At $54 a share, the upfront deal value represents a 19% premium to Akero’s average stock price over the past 30 days. The biotech’s share price climbed as high as $57 in the immediate aftermath of the February data drop.

Akero shareholders could bag a further $6 a share if efruxifermin (EFX) wins full U.S. regulatory approval for the treatment of compensated cirrhosis due to MASH by mid-2031. The contingent value right could swell the total value of the deal to $5.2 billion.

The outlay will give Novo another angle of attack on the MASH market. EFX, a FGF21 analog, is in a phase 3 program that is scheduled to start delivering data in the first half of next year. Akero said Novo’s capabilities in cardio-metabolic disease will accelerate the evaluation of EFX in the phase 3 program.

It's unclear when exactly Novo began its pursuit of Akero, but the biotech reportedly received buyout interest from an unnamed suitor back in May. Nevertheless, Novo has a new CEO in Mike Doustdar to put his name to the deal. In a statement, Doustdar said EFX “could become a cornerstone therapy, alone or together with Wegovy, to tackle one of the fastest-growing metabolic diseases of our time.”

The FDA approved Novo's Wegovy in MASH in August. David Moore, Novo's executive vice president of U.S. operations, talked up the MASH market on an earnings call shortly before the FDA approval, touting it as a chance to “differentiate Wegovy further in terms of that strength of the label” in an indication “that entire companies have been built upon.”

Novo will face competition for the opportunity. Madrigal Pharmaceuticals’ Rezdiffra is already approved in MASH, and a clutch of companies is giving chase. Roche is set to join the race through its deal to buy 89bio for up to $3.5 billion.

So far, Madrigal's Rezdiffra has been off to a strong start since its U.S. launch last April. In the first half of this year, the drug generated $350 million.