Protagonist Therapeutics, Inc. (NASDAQ: PTGX) is engaged as a biopharmaceutical company that primarily focuses on the research and development of multiple peptide-based investigational “new chemical entities” from its proprietary tech platform. Shares of the biopharma company shot up 94% during trading on Monday, October 11, 2021. Over the past three months, Protagonist Therapeutics has seen average daily volume of 1.02 million shares. However, volume of 45.59 million shares or dollar volume of $1.62 billion, exchanged hands during Monday’s trading.
Shares of Protagonist Therapeutics nearly doubled after the company announced that the U.S. Food and Drug Administration (FDA) has removed a full clinical hold on the Company’s rusfertude clinical studies. The hold was initially put in place on September 17, 2021. After the FDA’s latest ruling, rusfertide clinical studies may commence once again.
The FDA hold was initially put in place by a non-clinical finding in a 26-week rasH2 transgenic mouse model, which indicated benign and malignant subcutaneous skin tumors. This caused a re-examination and investigation into the four cancer cases that were observed during the clinical trials featuring over 160 patients. After a lengthy review, no additional cancer cases or other safety issues have since been identified.
The Company says they have provided the FDA will all requested documentation and data during its investigation. Protagonist Therapeutics says they will continue to work closely with investigators as clinical trials look to resume.
“We are extremely pleased that the FDA has acted so quickly in lifting the clinical hold on the rusfertide development program, allowing us to resume patient dosing in our clinical studies,” said Dinesh Patel, Ph.D.,President and Chief Executive Officer of Protagonist. “Patient safety continues to be our topmost priority. We believe that the cumulative evidence regarding the safety and clinical risk-benefit of rusfertide is supportive of expedited clinical development. We are actively preparing to initiate the phase 3 registrational study for polycythemia vera in the first quarter of 2022. Protagonist will continue to work closely with the FDA to ensure patient safety with amendments to current and planned future studies with rusfertide. We remain optimistic about the future potential of rusfertide to address unmet medical needs in excessive erythrocytosis and iron overload related diseases like polycythemia vera and hereditary hemochromatosis, respectively.”
Disclosure: Neither Spotlight Growth nor its officers have any position or relationship with any companies mentioned in this article. No payment was made to create this article. This article should not be taken as a solicitation or recommendation to buy or sell any securities. Please conduct your own research and consult your financial advisor to determine your risk tolerance and investment path. We are not licensed brokers or investment advisors.