Protagonist Therapeutics Inc. (PTGX) stock prices were up by 94.90% just before market trading commenced on October 11th, 2021. This brought the price per share up to USD$35.72 early on in the trading day.
Clinical Hold Removed
October 11th, 2021 saw PTGX stock announce the removal of the full clinical hold on its rusfertide clinical studies by the United States Food and Drug Administration. The hold was announced on September 17th 2021. As per this development, dosing in all clinical studies of rusfertide may be resumed. The FDA was provided with all the required necessary information, which became the basis for a Complete Response and resulted in the subsequent removal of the clinical hold. The company is collaborating with study investigators and clinical trial sites in order to hastily resume dosing of patients in ongoing clinical trials with rusfertide after patients have been reconsented.
Details of the Clinical Hold
The clinical hold was initially a result of a recent non-clinical finding in a 26 week rasH2 transgenic mouse model indicating benign and malignant subcutaneous skin tumors. A re-examination of the four cases of cancer observed across all rusfertide clinical trial was also triggered by the rasH2 signal. The trials involved more than 160 patients, with additional reexamination of a comprehensive review of the safety database, which included cases of suspected unexpected serious adverse reactions (SUSAR). The reexaminations did not uncover additional cancer cases, nor any other unexpected safety signals.
PTGX Stock Works with FDA
PTGX stock is excited with the FDA’s quick response in lifting the clinical hold on the rusfertide development program. Patient safety will continue to be the company’s utmost priority, with cumulative evidence about the safety and clinical risk-benefit of rusfertide consolidates efforts for expedited clinical development. The company is actively preparing to initiate the phase 3 registrational study for polycythemia vera in the first quarter of fiscal 2022. The company expects to continue working with the FDA to ensure patient safety with amendments to current and planned future studies with their proprietary rusfertide treatment.
Future Outlook for PTGX Stock
The company has had a strong quarter, consolidated by the expanded scope of opportunities resulting from the resumption of clinical trials. PTGX stock is keen to push for the accelerated development and commercialization of its proprietary rusfertide treatment. Current and potential investors are hopeful that management will be able to effectively leverage the resources at its disposal. This is hoped to facilitate consistent and organic increases in shareholder value over the long term.