Six months af­ter lift­ing hold, FDA wants to re­voke Pro­tag­o­nist's break­through ther­a­py des­ig­na­tion, biotech says

Though last Sep­tem­ber’s clin­i­cal hold on Pro­tag­o­nist Ther­a­peu­tics was lift­ed af­ter on­ly a few weeks, the biotech qui­et­ly dis­closed Wednes­day that an­oth­er FDA con­cern emerged from the pause.

US reg­u­la­tors in­tend to re­voke the break­through ther­a­py des­ig­na­tion for Pro­tag­o­nist’s ex­per­i­men­tal blood can­cer pro­gram rus­fer­tide, the biotech dis­closed in an SEC fil­ing and in­vestor pre­sen­ta­tion Wednes­day. The de­ci­sion, Pro­tag­o­nist says, stems from “ob­served ma­lig­nan­cies” re­lat­ed to the hold, ini­tial­ly im­posed on Sept. 16, 2021.

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