Veru Seeks FDA Emergency Use Nod For Its COVID-19 Treatment

  • Veru Inc VERU has submitted an emergency use authorization (EUA) for sabizabulin application to FDA for COVID-19 treatment.
  • The application covers moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS).
  • The EUA submission is based on the positive results from the Phase 3 COVID-19 clinical trial evaluating the efficacy and safety of sabizabulin in approximately 204 hospitalized COVID-19 patients at high risk for ARDS and death. 
  • Related: Veru's Stock Nearly Triples As COVID-19 Drugs Cuts Reduces Deaths By 55% In Hospitalized Patients.
  • "COVID-19 new cases and hospitalizations are on the rise again with a summer and fall-winter peaks expected," said Mitchell Steiner, Chairman, President, & CEO.
  • Veru is in Discussions with other regulatory agencies globally regarding emergency use authorization for sabizabulin, including the European Medicines Agency.
  • The company prepares for the U.S. Commercial Launch if EUA is granted.
  • Price Action: VERU shares are up 14.70% at $15.57 during the market session on the last check Tuesday.

Posted In: BriefsCOVID-19 Coronaviruswhy it's movingBiotechNewsHealth CareSmall CapFDAMoversTrading IdeasGeneral

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