{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-22-045517","form_type":"8-K","ticker":"PTGX","cik":"0001377121","company_name":"Protagonist Therapeutics, Inc","filed_at":"2022-04-13T23:59:59+00:00","discovered_at":"2026-05-14T18:04:00.413309+00:00","generated_at":"2026-06-26T07:37:33.340345+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA intends to rescind Breakthrough Therapy Designation for rusfertide; PN-943 Ph2 data due mid-May 2022","bullets":["FDA notified Protagonist of intent to rescind Breakthrough Therapy Designation for rusfertide in polycythemia vera; company requesting meeting to appeal.","PN-943 Phase 2 top-line data for ulcerative colitis expected in first half of Q2 2022 (by mid-May 2022).","Rusfertide Phase 3 VERIFY study screening underway; no anticipated changes to development plan or timelines.","Observed malignancies in rusfertide-treated patients explained; stopping rules align with background rates in PV population.","Fast Track and Orphan Drug designations for rusfertide remain active."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-22-045517","json":"https://secwatch.observer/filing/0001104659-22-045517.json","markdown":"https://secwatch.observer/filing/0001104659-22-045517.md","text":"https://secwatch.observer/filing/0001104659-22-045517.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1377121/000110465922045517/0001104659-22-045517-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1377121/000110465922045517/tm2212619d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T07:37:33.340345+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"}