{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-051581","form_type":"8-K","ticker":"HOOK","cik":"0001760542","company_name":"HOOKIPA Pharma Inc.","filed_at":"2024-04-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.936641+00:00","generated_at":"2026-06-03T08:09:20.634880+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"HOOKIPA announces pivotal Phase 2/3 trial design for HB-200 in combo with pembrolizumab; FDA alignment","bullets":["Pivotal Phase 2/3 trial for HB-200 + pembrolizumab in first-line HPV16+ recurrent/metastatic OPSCC; FDA alignment achieved.","Trial expected to enroll ~250 patients; Phase 2 primary analysis in 2026 with potential accelerated approval filing.","First patient enrollment anticipated in Q4 2024.","HB-200 abstract accepted as oral presentation at ASCO 2024 with data from ~40 patients in head and neck cancer.","Company also received PRIME designation from EMA for HB-200 in combination with pembrolizumab."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-051581","json":"https://secwatch.observer/filing/0001104659-24-051581.json","markdown":"https://secwatch.observer/filing/0001104659-24-051581.md","text":"https://secwatch.observer/filing/0001104659-24-051581.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1760542/000110465924051581/0001104659-24-051581-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1760542/000110465924051581/tm2412672d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T08:09:20.634880+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"}