Protagonist Therapeutics (NASDAQ:PTGX) stock is rocketing higher on Monday thanks to an update from the U.S. Food and Drug Administration (FDA) concerning rusfertide clinical studies.
According to a news release, Protagonist Therapeutics has to go ahead to resume dosing in its rusfertide clinical trials. This was previously on hold following concerns from the FDA brought up on Sept. 17.
The FDA required extra information and steps about the trials before they could resume. Protagonist Therapeutics met those requirements by submitting individual patient clinical safety reports, updating the investigator brochure and patient informed consent forms, performing a comprehensive review of the most recent safety database, as well as including new safety and stopping rules in the study protocols.
Dinesh Patel, Ph.D., president and CEO of Protagonist Therapeutics, said the following about today’s news.
“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.”
Protagonist Therapeutics notes that it’s moving forward with study plans, which include its Phase 3 registrational study for polycythemia vera. It expects to start that in the first quarter of 2022.
PTGX stock is performing well today following the FDA update. As a result, some 17 million shares of the stock are trading hands. That’s a hefty increase over its daily average trading volume of about 1 million shares.
PTGX stock was up 87.5% as of Monday morning. That has it well on its way to recovering the losses it experienced dosing was halted in September.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
