{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-21-117017","form_type":"8-K","ticker":"PTGX","cik":"0001377121","company_name":"Protagonist Therapeutics, Inc","filed_at":"2021-09-17T23:59:59+00:00","discovered_at":"2026-05-14T18:04:17.886431+00:00","generated_at":"2026-06-29T02:54:45.608251+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA places clinical hold on Protagonist's rusfertide program after tumor finding in mouse study","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-21-117017","json":"https://secwatch.observer/filing/0001104659-21-117017.json","markdown":"https://secwatch.observer/filing/0001104659-21-117017.md","text":"https://secwatch.observer/filing/0001104659-21-117017.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1377121/000110465921117017/0001104659-21-117017-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1377121/000110465921117017/tm2127921d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-29T02:54:45.608251+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}