VERU - Veru surges 11% as FDA announces AdCom meeting to review COVID-19 therapy

• VERU ( NASDAQ: VERU ) shares added 11% in pre-market trading Wednesday after the FDA announced an Advisory Committee meeting to review the company’s emergency use authorization (EUA) application for its oral COVID-19 therapy sabizabulin.
• At the Oct. 06 meeting, FDA’s Pulmonary-Allergy Drugs Advisory Committee will focus on key issues related to sabizabulin, including its therapeutic effect in terms of the high placebo mortality rate and the limited size of the safety database.

• The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.

• In June, VERU shares surged after the company announced the EUA submission seeking FDA clearance for sabizabulin to treat hospitalized patients with moderate to severe COVID-19 who are at risk of developing acute respiratory distress syndrome.
• However, several days later, Culper Research released a short report questioning the data behind the efficacy of sabizabulin.

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