Protagonist Therapeutics Announces FDA Clinical Hold on Rusfertide Clinical Development Program | Financial Buzz

Protagonist Therapeutics Announces FDA Clinical Hold on Rusfertide Clinical Development Program

Protagonist Therapeutics, Inc. (NASDAQ: PTGX) has reported that its investigational product candidate in development, rusfertide has been put on a clinical hold.  The FDA notified Protagonist Therapeutics of a non-clinical finding in a 26-week rasH2 transgenic mouse model study.  The rasH2 model is designed to detect signals that are related to tumorigenicity and benign and malignant skin tumors were observed in this study. 

Protagonist continues to work with the FDA to make the proper updates to the clinical study documents to determine the next steps in consultation with the FDA.  The company plans to provide additional clinical safety reports, update investigator brochures and patient informed consent forms. 

“Patient safety is our absolute top priority,” said Dinesh Patel, President and Chief Executive Officer of Protagonist. “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.”

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