After an RTF and some stern warnings, FDA slaps CytoDyn with two clinical holds
CytoDyn’s colorful and infamous CEO may be gone, but the issues that began festering during his long reign are very much here to stay.
The biotech disclosed two FDA clinical holds on its lead drug, the CCR5 antagonist leronlimab, after market close on Wednesday: a partial hold on the HIV program, and a full one on the Covid-19 program. As a result, some patients on HIV extension trials will have to be transitioned to other therapy options, while CytoDyn would not be able to start new Covid-19 trials in the US.
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