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 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.