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Why Veru Is Rising In Pre-market?

Veru Inc. (VERU) reported positive efficacy and safety results from a planned interim analysis of the placebo-controlled phase 3 COVID-19 trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome. The Independent Data Safety Monitoring Committee recommended that the study be halted early due to efficacy. The company plans to meet with FDA to discuss next steps including the submission of an emergency use authorization application.

The phase 3 trial involved approximately 210 hospitalized moderate to severe COVID-19 patients who were at high. The company said Sabizabulin treatment resulted in a clinically and statistically meaningful 55% relative reduction in deaths in the intent to treat population. Sabizabulin treatment was well tolerated in this patient population, the company noted.

Shares of Veru Inc. were up 33% in pre-market trade on Monday.

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