Protagonist Therapeutics Inc. (NASDAQ: PTGX) stock declined by 0.73% at the last close while the PTGX stock plunged by 55.08% in the pre-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 business’s proprietary technological platform.
PTGX stock’ Significant Development
Protagonist Therapeutics has received verbal notification from the United States Food and Drug Administration (FDA) that its clinical investigations for rusfertide, an experimental product candidate presently in production, have been put on hold.
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Protagonist notified the FDA of a recent non-clinical result in a 26-week rasH2 transgenic mouse model research, prompting the clinical hold. The rasH2 model is intended to identify signals related to tumorigenicity, and this analysis revealed both benign and malignant subcutaneous skin tumours.
The company is collaborating with the FDA and will be ready to make all necessary modifications to clinical study documentation as well as establish next steps in collaboration with the agency. They’ll offer more clinical safety reports, update investigator pamphlets and patient informed consent forms, and make appropriate changes to study procedures, among other things. The administration of rusfertide to patients in all active clinical trials will be halted.
Dinesh Patel, President and CEO of Protagonist stated that their number one goal is the safety of our patients. They are firmly committed to collaborating with the FDA to better understand and assess any clinical concerns, as well as to determine the next stages in the development of rusfertide.
More about PTGX stock
Rusfertide (PTG-300), an experimental injectable hepcidin mimic in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV individuals with high hematocrit levels, and a Phase 2 study for hereditary hemochromatosis, are among Protagonist’s pipeline candidates. In addition, the company is testing an orally given, gut-restricted alpha-4-beta-7 integrin specific antagonist peptide (PN-943) in individuals with moderate to severe active ulcerative colitis in Phase 2 research (UC). As a first indicator, the company is focusing on ulcerative colitis.