Veru Inc. Announces FDA Support in Request for Emergency Use Authorization

May 11, 2022 By MarketDepth

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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