FDA lifts clinical hold on rusfertide program

Protagonist Therapeutics (Nasdaq: PTGX) saw its share leap nearly 100% to $35 after the company revealed that the US Food and Drug Administration has lifted the full clinical hold on its rusfertide clinical studies, announced on September 17, 2021.

This means that all clinical studies of rusfertide, an investigational new drug being evaluated for the treatment of polycythemia vera (P00V), a type of blood cancer, may be resumed.

Protagonist provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, the company provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comprehensive review of the most recent safety database, and included new safety and stopping rules in the study protocols. Protagonist says it is working closely with study investigators and clinical trial sites to resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.