Protagonist Therapeutics Reports Removal of Clinical Hold by FDA on Rusfertide Studies

Oct 11, 2021 By MarketDepth

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Protagonist Therapeutics, Inc. (NASDAQ: PTGX) has reported that the FDA has removed its full clinical hold on the Company’s rusfertide Clinical Studies.  Dosing in all clinical studies of rusfertide may be resumed.  All information that was requested by the FDA was provided as a Complete Response.  

“We are extremely pleased that the FDA has acted so quickly in lifting the clinical hold on the rusfertide development program, allowing us to resume patient dosing in our clinical studies. Patient safety continues to be our topmost priority. We believe that the cumulative evidence regarding the safety and clinical risk-benefit of rusfertide is supportive of expedited clinical development. We are actively preparing to initiate the phase 3 registrational study for polycythemia vera in the first quarter of 2022. Protagonist will continue to work closely with the FDA to ensure patient safety with amendments to current and planned future studies with rusfertide. We remain optimistic about the future potential of rusfertide to address unmet medical needs in excessive erythrocytosis and iron overload related diseases like polycythemia vera and hereditary hemochromatosis, respectively.”

Dinesh Patel, Ph.D., President and Chief Executive Officer of Protagonist