CYDY - CytoDyn hit by clinical holds on HIV and COVID-19 programs in the U.S.

Development-stage biotech, CytoDyn (OTCQB:CYDY) announced on Wednesday that the Food and Drug Administration (FDA) placed a partial clinical hold on its HIV program and a full clinical hold on its COVID-19 program in the U.S. In addition, CytoDyn (CYDY) has decided to pause its COVID-19 trials in Brazil subject to results from a previously scheduled data safety monitoring committee meeting. A decision on the timing of marketing application for HIV therapy is also currently under conder consideration, the company said. “We are evaluating our clinical programs and are working to resolve the issues underlying the clinical holds as soon as possible in close communication with the FDA,” Chief Medical Officer Scott A. Kelly remarked.

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CytoDyn hit by clinical holds on HIV and COVID-19 programs in the U.S.