Why Veru Shares Are Soaring Today Premarket

In a Pre-EUA meeting, FDA said Veru Inc VERU should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients.
The FDA agreed that the Phase 3 COVID-19 study stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for EUA submission and marketing application submission.
FDA agreed that the current safety data available for sabizabulin is sufficient to support the safety portion of a request for EUA submission.
Related: Veru's Stock Nearly Triples As COVID-19 Drugs Cuts Reduces Deaths By 55% In Hospitalized Patients.
The agency informed Veru that additional safety data that would be collected during the use of sabizabulin under the EUA, if granted, will be sufficient to support marketing application submission.
Furthermore, no additional safety clinical studies are required.
The company plans to submit a request for a EUA application in calendar 2Q 2022.
The company has initiated discussions with government agencies to discuss government purchases of sabizabulin in the U.S. and other countries.
Price Action: VERU shares are up 24.3% at $9.68 during the premarket session on the last check Wednesday.
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