Veru Inc. Announces FDA Support in Request for Emergency Use Authorization
May 11, 2022 By MarketDepth
Veru Inc. (NASDAQ: VERU) today announced that the U.S. Food and Drug Administration has agreed that the efficacy and safety data from Veru’s completed Phase 3 clinical study sufficient to support the submission of a request for Emergency Use Authorization (EUA).
Shares Up Premarket
Shares of Veru Inc. (NASDAQ: VERU) gained over 24% during the premarket trading session following the announcement.
“The discussion with FDA in the Pre-EUA meeting has established a direct path forward to expedite the availability of sabizabulin to the high risk hospitalized patients with COVID-19.”Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru
The FDA agrees that the completed Phase 3 clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome is sufficient to support the efficacy portion of a request for EUA submission and for an NDA submission. As a result, Veru plans to submit a request for an EUA application in calendar 2Q 2022.
“In the Phase 3 COVID-19 clinical study, sabizabulin demonstrated a clear mortality benefit in hospitalized moderate to severe COVID-19 patients on current standard of care with no significant safety signals.”Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru