{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-396716","form_type":"8-K","ticker":"NAMS","cik":"0001936258","company_name":"NewAmsterdam Pharma Co N.V.","filed_at":"2026-09-21T20:30:15+00:00","discovered_at":"2026-09-21T20:31:09.330275+00:00","generated_at":"2026-09-21T20:31:42.031755+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"European Commission approves obicetrapib (Ubeslo/Evlarco) for hypercholesterolaemia; first approval worldwide","bullets":["EC granted marketing authorization for Ubeslo (obicetrapib 10mg) and Evlarco (obicetrapib+ezetimibe FDC) for primary hypercholesterolaemia or mixed dyslipidaemia; first global approval.","Authorizations cover all EU states plus Iceland, Liechtenstein, Norway; require post-authorization efficacy study, including final PREVAIL outcomes trial results.","Menarini holds exclusive EU commercialization rights; NewAmsterdam receives tiered double-digit royalties (low double-digits to mid-twenties %) on net sales.","Up to €833M in milestones; mid-teens of millions euros triggered directly by these EC approvals for obicetrapib and the FDC."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-396716","json":"https://secwatch.observer/filing/0001193125-26-396716.json","markdown":"https://secwatch.observer/filing/0001193125-26-396716.md","text":"https://secwatch.observer/filing/0001193125-26-396716.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1936258/000119312526396716/0001193125-26-396716-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1936258/000119312526396716/nams-20260921.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-21T20:31:42.031755+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"}