Protagonist Shares Almost Double As FDA Lifts Clinical Hold On Rusfertide Program

The FDA has removed the full clinical hold on Protagonist Therapeutics Inc's (NASDAQ:PTGX) rusfertide clinical studies. The Company provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms. The clinical hold was initially triggered by a recent non-clinical finding in a 26-week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. The rasH2 signal also prompted a re-examination of the four cancer cases observed across all rusfertide clinical trials involving over 160 patients and a comprehensive review of the safety database. No additional cancer cases, and no other unexpected safety signals, surfaced in this process. Protagonist says it is actively preparing to initiate the phase 3 study for polycythemia vera in Q1 of 2022. Related content: Benzinga's Full FDA Calendar. Price Action: PTGX shares are up 90.30% at $34.70 during the premarket session on Monday's last check.

Protagonist Shares Almost Double As FDA Lifts Clinical Hold On Rusfertide Program

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