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Why Veru Shares Are Soaring Today Premarket

By Vandana Singh
  • In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERUshould 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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Dive Deeper:
The Daily Biotech Pulse: Veru Shares Up On COVID Candidate Update, FDA Approves Lilly's COVID Treatment, Latest On Sanofi-AstraZeneca RSV Vaccine
Here's a roundup of top developments in the biotech space over the last 24 hours:
Why Are Inovio Shares Plummeting Today
Joseph Kim, the longtime CEO of Inovio Pharmaceuticals Inc (NASDAQ:INO), is stepping down to make room for Jacqueline Shea, who first joined Inovio as…
FDA Approves Lilly and Incyte's OLUMIANT (baricitinib) for Hospitalized Patients with COVID-19
The U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized patients.
Moderna Concludes FDA Submission For Its COVID-19 Shot In Adolescents, Kids
Reuters reported that Moderna Inc (NASDAQ:MRNA) had made required submissions to the FDA for emergency use authorization of its COVID-19 vaccine in adolescents…
One subscription that gives you access to news from hundreds of sites
Here's Why AdaptHealth Shares Are Soaring Today
AdaptHealth Corp (NASDAQ: AHCO) says it delivered solid Q1 net revenue and Adjusted EBITDA as it began to overcome ongoing challenges…
Eisai - Biogen Seek Accelerated Approval For Their Second Alzheimer's Drug
Eisai Co Ltd (OTC:ESALY) has completed the rolling submission of the FDA marketing application under the accelerated approval for lecanemab (BAN2401) for mild…
Get all your news in one place