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Stock impact report

EMA grants PRIME designation to Akero Therapeutics' efruxifermin [Seeking Alpha]

Akero Therapeutics, Inc. (AKRO) 
Last akero therapeutics, inc. earnings: 3/16 07:30 am Check Earnings Report
Company Research Source: Seeking Alpha
HealthcareEMA grants PRIME designation to Akero Therapeutics' efruxiferminOct. 16, 2020 7:46 AM ET|Akero Therapeutics, Inc. (AKRO)Mamta MayaniThe European Medicines Agency (EMA) hasgranted(NASDAQ:PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.Also, the EMA's Committee on Human Medicinal Products (CHMP) indicated preliminary 16-week data from Akero's Phase 2a trial, the BALANCED study of EFX in biopsy-confirmed NASH patients.The CHMP also expressed that the totality of data, including histology data as well as biomarker data, together with better glycemic control and amelioration of dyslipidemia, suggest potential benefit not only for treatment of NASH but also the broader context of metabolic syndrome common in NASH patients.The company plans to initiate a Phase 2b/3 adaptive trial of EFX in biopsy-confirmed NASH patients in H1 2021.Click to subscribe to real-time analytics o Show less Read more
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