Earlier today, Akero Therapeutics Inc AKRO reported a 36-week analysis of SYMMETRY, a 96-week Phase 2b study of efruxifermin (EFX) in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH).
Efruxifermin was not statistically significant in topping the placebo in improving liver scarring without worsening of NASH, resulting in shares tumbling.
The disappointing update from Akero also dragged down shares of its rival 89bio Inc ETNB.
Both companies are testing drugs that mimic a metabolic hormone called FGF21 NASH.
Both Akero and 89bio are developing candidates engineered to mimic the biological activity of fibroblast growth factor 21 (FGF21), which regulates multiple metabolic pathways and cellular processes, with a possible treatment of NASH.
Last month, 89bio's pegozafermin received an FDA Breakthrough Therapy Designation for nonalcoholic steatohepatitis.
In March, 89bio released topline data from the Phase 2b ENLIVEN trial of pegozafermin for NASH. In the study, the 44mg every two weeks and 30mg weekly (QW) doses met, with high statistical significance, both the primary histology endpoints per the FDA guidance on endpoints and statistical analysis.
Price Action: ETNB shares are down 34.5% at $10.17 on the last check Tuesday.
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