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.