secwatch.observer — SEC 8-K summary
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Issuer:     Protagonist Therapeutics, Inc (PTGX)
CIK:        0001377121
Form:       8-K
Filed at:   2021-09-17T23:59:59+00:00
Accession:  0001104659-21-117017
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA places clinical hold on Protagonist's rusfertide program after tumor finding in mouse study
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- FDA clinical hold on all rusfertide studies after rasH2 mouse model showed benign/malignant subcutaneous skin tumors.
- Four cancer cases observed across rusfertide trials assessed as unrelated; company providing additional safety data to FDA.
- Dosing paused in all ongoing trials; investigators contacted to notify patients.
- Rusfertide is a Phase 2 hepcidin mimetic for polycythemia vera and hereditary hemochromatosis.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1377121/000110465921117017/0001104659-21-117017-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1377121/000110465921117017/tm2127921d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-21-117017

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer