Protagonist Nearly Doubles After FDA Lifts Clinical Hold On Its Investigational Blood Cancer Drug

Shares of Protagonist Therapeutics Inc. (PTGX) soared nearly 100% on Monday morning driven by the news that the U.S. Food and Drug Administration has removed the full clinical hold on the company's Rusfertide clinical studies.

PTGX is currently trading at $35.87, up $17.63 or 96.66%, on the Nasdaq, on a volume of 10.4 million shares, far above average volume of 1 million shares. The stock has traded between $12.80 and $50.54 in the 52-week period.

The company said it provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold.

Rusfertide is an injectable hepcidin mimetic in a Phase 2 proof-of-concept clinical trial for polycythemia vera, a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2 study for hereditary hemochromatosis.

According to Mayo Clinic, Polycythemia vera is a type of blood cancer. It causes your bone marrow to make too many red blood cells. These excess cells thicken your blood, slowing its flow, which may cause serious problems, such as blood clots. Polycythemia vera is rare.

The company said all ongoing clinical trials of rusfertide to resume dosing and phase 3 registrational trial planned to commence in the first quarter of 2022.

Previously, the FDA had put the drug on clinical hold based on Protagonist's notification of a non-clinical finding in a 26-week rasH2 transgenic mouse model study. The rasH2 model is designed to detect signals related to tumorigenicity, and benign and malignant subcutaneous skin tumors were observed in this study.

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