{"schema_version":"secwatch.filing_event.v1","accession":"0001559053-22-000014","form_type":"8-K","ticker":"PRTA","cik":"0001559053","company_name":"PROTHENA CORP PUBLIC LTD CO","filed_at":"2022-03-28T23:59:59+00:00","discovered_at":"2026-05-14T18:04:06.979727+00:00","generated_at":"2026-06-26T16:03:59.639574+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA clears IND for Prothena's PRX012 subcutaneous anti-Aβ antibody; Phase 1 SAD study initiated","bullets":["FDA cleared IND for PRX012, a potential best-in-class anti-amyloid beta antibody for Alzheimer's disease.","Phase 1 single ascending dose study in healthy volunteers and AD patients has started; MAD study expected by year-end 2022.","PRX012 designed for subcutaneous dosing with high binding potency; preclinical data show plaque occupancy at low doses.","Prothena expects PRX012 to serve as a foundational anti-Aβ treatment with convenient administration."],"urls":{"canonical":"https://secwatch.observer/filing/0001559053-22-000014","json":"https://secwatch.observer/filing/0001559053-22-000014.json","markdown":"https://secwatch.observer/filing/0001559053-22-000014.md","text":"https://secwatch.observer/filing/0001559053-22-000014.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1559053/000155905322000014/0001559053-22-000014-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1559053/000155905322000014/prta-20220328.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T16:03:59.639574+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"}