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.
  • Photo by Gerd Altman via Pixabay
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