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FDA accepts Achaogen's marketing application for plazomicin for cUTI, action date June 25; shares ahead 9% premarket

Published 01/02/2018, 08:36 AM
© Reuters.  FDA accepts Achaogen's marketing application for plazomicin for cUTI, action date June 25; shares ahead 9% premarket
AKAOQ
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  • Achaogen (NASDAQ:AKAO) is up 9% premarket on average volume in response to its announcement that the FDA has accepted for review its marketing application seeking approval for aminoglycoside antibiotic plazomicin for the treatment of complicated urinary tract infections (cUTI). Under Priority Review status, the agency's action date is June 25. An advisory committee review is planned.
  • The company says it will file an application in Europe later this year.
  • Now read: Achaogen: Rebound Likely In 2018


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