Protagonist Therapeutics Inc. (NASDAQ: PTGX) stock gained by 85.72% in the current market trading session. Protagonist Therapeutics is a pharmaceutical business that is developing a number of peptide-based investigational novel chemical entities, all of which are based on the firm’s unique technological platform.
PTGX stock’ Current Development
The US Food and Drug Administration (FDA) has lifted the complete clinical hold on Protagonist Therapeutics’ rusfertide clinical trials, which were disclosed on September 17, 2021. Dosing in all rusfertide clinical studies may be restarted, according to the FDA.
As the foundation for a Complete Response and subsequent lifting of the clinical hold, the Company submitted the FDA with all required data. The Company, specifically, delivered the necessary individual patient clinical safety reports, revised the investigator brochure and patient notified consent forms, conducted a thorough assessment of the most recent safety database, and updated the research procedures with new safety and stopping guidelines. After patients have given their permission, the Company is working closely with study investigators and clinical trial sites to restart the dosing of rusfertide in ongoing clinical trials.
A recent non-clinical result in a 26-week rasH2 transgenic mice model suggesting benign and malignant subcutaneous skin cancers prompted the clinical hold. The rasH2 signal also triggered a re-examination of the four cases of cancer found in all rusfertide clinical trials involving over 160 individuals, as well as a thorough assessment of the safety database, which included suspected cases of unanticipated significant adverse responses (SUSAR). During this procedure, no new cancer cases or other unforeseen safety alerts emerged.
Dinesh Patel, President and Chief Executive Officer of Protagonist stated,
They are thrilled that the FDA has swiftly lifted the clinical hold on the rusfertide development program, allowing them to restart patient dosing in the clinical trials. Their main focus remains to be patient safety. They think that the body of information on rusfertide’s safety and clinical risk-benefit ratio supports its rapid clinical advancement. They’re working hard to start the polycythemia vera phase 3 registration trial in the first quarter of 2022.