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.