Spero Therapeutics Receives FDA Fast Track Designation for SPR994 for the treatment of Complicated Urinary Tract infections and Acute Pyelonephritis
Spero Therapeutics, Inc. (SPRO)
Last spero therapeutics, inc. earnings: 3/16 08:45 am
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Source: GlobeNewswire
CAMBRIDGE, Mass., March 29, 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 and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for SPR994, Spero’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis. “We are pleased that the FDA has granted fast track status for SPR994,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “Receiving Fast Track status highlights the serious unmet need of multi-drug resistant infections and we look forward to working closely with the FDA as we conduct our planned pivotal Phase 3 clinical trial through the possible NDA submission with the goal of providing
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SPRO
Earnings
- 3/13/24 - Beat
SPRO
Sec Filings
- 4/16/24 - Form ARS
- 4/16/24 - Form DEFA14A
- 4/16/24 - Form DEF
- SPRO's page on the SEC website