{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-019516","form_type":"8-K","ticker":"PTGX","cik":"0001377121","company_name":"Protagonist Therapeutics, Inc","filed_at":"2025-03-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.472145+00:00","generated_at":"2026-05-25T17:10:13.259653+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Protagonist and Takeda announce positive Phase 3 topline data for rusfertide in polycythemia vera; primary endpoint met","bullets":["77% of rusfertide patients achieved clinical response vs 33% placebo (p<0.0001) during weeks 20-32.","Mean phlebotomies per patient: 0.5 rusfertide vs 1.8 placebo (p<0.0001) over 32 weeks (EU primary endpoint).","All four key secondary endpoints met, including hematocrit control and patient-reported outcomes.","Safety profile consistent with prior studies; no new safety signals; serious AEs not drug-related.","NDA filing for rusfertide expected in second half of 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-019516","json":"https://secwatch.observer/filing/0001104659-25-019516.json","markdown":"https://secwatch.observer/filing/0001104659-25-019516.md","text":"https://secwatch.observer/filing/0001104659-25-019516.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1377121/000110465925019516/0001104659-25-019516-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1377121/000110465925019516/tm258056d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-25T17:10:13.259653+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"}