After only three $1 billion-plus biopharma deals in November, December saw 14 blockbuster deals worth a total of $21.92 billion, including four deals worth more than $2 billion.
In one of the biggest deals of the waning year, Novo Nordisk A/S is buying Akero Therapeutics Inc. to bolster its metabolic dysfunction-associated steatohepatitis (MASH)-treatment portfolio. In the $5.2 billion deal, Akero brings its fibroblast growth factor 21 analogue, efruxifermin, which is in a phase III study for treating those with moderate to advanced liver fibrosis and those with cirrhosis.
Yesterday’s first part of this two-part series surveyed bispecific antibodies for immunological and inflammatory (I&I) disease. Apart from bispecifics, Leerink analyst Thomas Smith lately has proven interested in I&I overall, unveiling his “five for 2025” in a January report that listed five indications with “potential for disruption” in the year ahead.
What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of what executives called “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of earlier effect size, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 97% to close Jan. 27 at $51.71.
For the time being, Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) stands alone as the only U.S. FDA approved treatment for treating nonalcoholic steatohepatitis (NASH). But new and positive data from multiple companies show Madrigal may soon have company.
Akero Therapeutics Inc.’s phase IIb data with FGF21 analogue efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) kept interest alive in the face-off between the company and 89bio Inc. with pegozafermin, another FGF21 drug targeting MASH, for which a phase III study is planned.
Hopes raised by the phase IIb Harmony study with FGF21 analogue efruxifermin (EFX) in pre-cirrhotic nonalcoholic steatohepatitis (NASH), which appeared in a scientific journal last week, were less than fulfilled as Akero Therapeutics Inc. rolled out disappointing 36-week results from another, same-stage trial called Symmetry in NASH patients with cirrhosis. The company is forging ahead with U.S. FDA talks to figure out how a phase III effort might be designed.
Shares in Akero Therapeutics Inc. more than doubled in value after the company announced results from a phase IIb nonalcoholic steatohepatitis trial that it believes show lead candidate efruxifermin could challenge other candidates in development for the fatty liver disease targeted by so many biotechs and big pharmas.
Strongly positive histological data from Akero Therapeutics Inc. is being seen as setting a potentially new high bar in treating nonalcoholic steatohepatitis (NASH), but 89bio Inc.’s NASH treatment, on a similar development timeline, is sharing in the success.
