Akero Therapeutics is a clinical-stage biotech focused entirely on developing efruxifermin (EFX), a drug candidate for MASH (metabolic dysfunction-associated steatohepatitis), a severe liver disease characterized by inflammation and fibrosis that can progress to cirrhosis, liver failure, and death. EFX is an engineered analog of FGF21, a naturally occurring hormone that regulates fat and sugar metabolism. Akero extended EFX's half-life to roughly three days, enabling once-weekly self-injection. EFX targets two patient populations: pre-cirrhotic MASH (F2-F3 fibrosis) and compensated cirrhosis due to MASH (F4), the latter of which has no approved treatments. Phase 2b trials showed strong results, with EFX notably achieving statistically significant cirrhosis reversal — the only compound reported to have done so in clinical trials. EFX has FDA Fast Track, FDA Breakthrough Therapy, and EMA PRIME designations. Akero is currently running SYNCHRONY, a Phase 3 program of roughly 3,500 patients across three trials, with key histology results expected in the first half of 2027. Akero has no revenue, no approved products, and is funded entirely through equity. If approved, Akero plans to build a U.S. salesforce targeting hepatologists and gastroenterologists, while pursuing partnerships for international markets. EFX was originally licensed from Amgen, which retains milestone payments and royalty rights on net sales.
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