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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