VERU - Veru crashes 65% as trading resumes after AdCom snub for COVID-19 therapy

• Veru Inc. ( NASDAQ: VERU ), a biopharma targeting cancer, shed ~65% of its value on Thursday pre-market after a group of independent experts at the FDA voted against granting the emergency use authorization (EUA) for its oral COVID-19 therapy sabizabulin.
• The selloff comes after Veru ( VERU ) shares resumed trading following the decision by the FDA's Pulmonary-Allergy Drugs Advisory Committee to conclude that the benefits of sabizabulin do not outweigh the risks.
• The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
• Issuing a press release after the vote, Veru ( VERU ) said that there were discussions on the design of an additional clinical trial as a potential post-authorization requirement.
• "We look forward to continuing to work with the FDA as we continue our efforts to ensure that this product is available to patients in a timely manner," Chief Executive Mitchell Steiner remarked.
• Very ( VERU ) shares surged on Monday ahead of the vote, even as the FDA staff raised concerns about the data the company used for its EUA request.

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