Veru provides update on fda advisory committee meeting regarding emergency use authorization of sabizabulin to treat hospitalized covid-19 patients at high risk for acute respiratory distress syndrome

Miami, fl, nov. 09, 2022 (globe newswire) -- veru inc. (nasdaq: veru), a biopharmaceutical company focused on developing novel medicines for covid-19 and other viral ards-related diseases and for oncology, announces the results of today's meeting of the u.s. food and drug administration's (fda) pulmonary-allergy drugs advisory committee (padac), which reviewed sabizabulin for emergency use authorization (eua) in hospitalized moderate to severe covid-19 patients who are at high risk for acute respiratory distress syndrome (ards). the advisory committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with covid-19 at high risk of ards do not outweigh the known and potential risks of sabizabulin. however, there was additional discussion around the clinical trial design aspects of an additional clinical trial as a potential post authorization requirement. fda will consider the input of the advisory committee as part of their review of the eua and render a decision on the emergency use authorization.
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