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Stock impact report

Spero Therapeutics Announces FDA Acceptance of IND Application for SPR994

Spero Therapeutics, Inc. (SPRO) 
Last spero therapeutics, inc. earnings: 3/16 08:45 am Check Earnings Report
US:NASDAQ Investor Relations: investors.sperotherapeutics.com/overview
Company Research Source: GlobeNewswire
CAMBRIDGE, Mass., Feb. 04, 2019 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections, today announced the acceptance by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for SPR994, Spero’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI).  This IND acceptance will enable Spero to initiate U.S. enrollment in its planned global, single pivotal Phase 3 clinical trial of SPR994 in cUTI.  “With the FDA’s acceptance of our IND application for SPR994, we are excited to continue our Phase 3 initiation efforts, including opening clinical trial sites for enrollment in the U.S.," said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutic Show less Read more
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