In quick turn­around, FDA lifts full clin­i­cal hold on Pro­tag­o­nist's blood can­cer pro­gram

Not even a month af­ter be­ing slapped with a full clin­i­cal hold on all stud­ies re­lat­ed to a blood can­cer pro­gram, Pro­tag­o­nist Ther­a­peu­tics saw reg­u­la­tors re­verse course.

Pro­tag­o­nist’s ex­per­i­men­tal drug rus­fer­tide is cleared to re­sume dos­ing in all stud­ies, the biotech an­nounced Mon­day morn­ing, paving the way for re­searchers to launch a Phase III tri­al in poly­cythemia ve­ra ear­ly next year. The move comes ex­act­ly 25 days af­ter the FDA halt­ed rus­fer­tide stud­ies due to skin tu­mors aris­ing in mice treat­ed with the drug.

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