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Protagonist Therapeutics (PTGX) Stock Plunges As FDA Puts Clinical Hold On Rusfertide Program

Updated: 17 Sep 2021

Protagonist Therapeutics (NASDAQ: NASDAQ: PTGX) shares have plunged premarket on news that the US Food and Drug Administration (FDA) has put a clinical hold on Protagonist's clinical studies for rusfertide.

A clinical hold is issued by the FDA “to delay a proposed clinical investigation or to suspend an ongoing investigation.” When a study is placed on clinical hold, dosing in all current trials is to be halted.

The company said it received verbal communication from the FDA following its notification to the FDA of a recent non-clinical finding in a 26-week rasH2 transgenic mouse model study. The rasH2 study is designed to detect signals related to tumorigenicity, and benign and malignant subcutaneous skin tumors were observed in this study.

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PTGX said it is currently working with the FDA and is prepared to make the appropriate updates to the study documents and discuss the next steps.

Study investigators have been contacted to facilitate patient notification.

“We are fully committed to working closely with the FDA in understanding and evaluating potential clinical risks and determining next steps for the development of rusfertide,” said Dinesh Patel, President and Chief Executive Officer of Protagonist.

The company's shares have plunged over 52% to $21.99 following the news, erasing recent gains. The last time its shares traded at the current level was back in early February.

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