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Stock impact report

Akero Therapeutics Receives FDA Fast Track Designation for Efruxifermin (EFX) for the Treatment of NASH

Akero Therapeutics, Inc. (AKRO) 
Last akero therapeutics, inc. earnings: 3/16 07:30 am Check Earnings Report
Company Research Source: GlobeNewswire
SOUTH SAN FRANCISCO, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program investigating efruxifermin (EFX) for the treatment of non-alcoholic steatohepatitis (NASH). The Fast Track designation facilitates the development of new drugs to treat serious conditions where there is an unmet medical need. This designation enables more frequent interactions with the FDA and potential eligibility for priority review if clinical data support it. EFX is currently being evaluated in two parallel Phase 2b clinical trials in NASH patients, one (the HARMONY study) in adult patients with F2/F3 fibrosis and a second (the SYMMETRY study) in adult patients with late-stage cirrhotic NASH (F4), who are at elevated risk of liver failure and hav Show less Read more
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