FDA's amenability to existing data adds to hope for Veru approval in COVID-19

11 May 2022

Shares in Miami, USA-based Veru (Nasdaq: VERU) were 4% higher at lunchtime Wednesday on the back of some good news from the US Food and Drug Administration (FDA).

Veru announced that in a meeting on Tuesday, the FDA agreed that the efficacy and safety data from the completed Phase III study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome were sufficient to support the submission of a request for Emergency Use Authorization (EUA).

"A direct path forward to expedite the availability of sabizabulin to the high risk hospitalized patients with COVID-19"In April, Veru announced positive efficacy and safety data from the study of sabizabulin in hospitalized COVID-19 patients.

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