AKRO - Akero's liver disease drug gets FDA breakthrough therapy tag
- The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to Akero Therapeutics' ( NASDAQ: AKRO ) efruxifermin (EFX) to treat nonalcoholic steatohepatitis (NASH).
- NASH is a condition in which there is inflammation and damage to the liver caused by a buildup of fat in the liver. There are currently no approved therapies for NASH, which affect about 17M Americans, according to the company.
- The company said the FDA decision was backed by data from a phase 2b study called HARMONY.
- Akero added that it expects to report results from an ongoing phase 2b study, dubbed SYMMETRY, in H2 2023.
- AKRO +1.23% to $42.68 premarket Dec. 8
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Akero's liver disease drug gets FDA breakthrough therapy tag