Veru: FDA Declines To Grant Request For Emergency Use Authorization For Sabizabulin

(RTTNews) - Veru Inc. (VERU) announced the FDA has declined to grant at this time the company's request for Emergency Use Authorization for sabizabulin for treatment of hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome.

The FDA also provided comments on a proposed confirmatory Phase 3 study protocol submitted by the company for hospitalized moderate to severe COVID-19 patients at risk for Acute Respiratory Distress Syndrome and death that could support a new EUA authorization and/or NDA approval. FDA said in the potential confirmatory Phase 3 clinical study design: "strong consideration should be given to appropriate time frames for interim analyses so that - should a strong efficacy signal again be observed - the trial could be stopped in an efficient time frame."

Shares of Veru are down 31% in pre-market trade on Friday.

For More Such Health News, visit rttnews.com.