{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-315163","form_type":"8-K","ticker":"NAMS","cik":"0001936258","company_name":"NewAmsterdam Pharma Co N.V.","filed_at":"2026-07-24T12:03:32+00:00","discovered_at":"2026-07-24T12:05:00.270378+00:00","generated_at":"2026-07-24T12:05:07.228481+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"NewAmsterdam Pharma and Menarini receive positive CHMP opinion for obicetrapib products in Europe","bullets":["CHMP recommends marketing authorization for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib/ezetimibe FDC) for hypercholesterolemia.","Recommendation based on Phase 3 BROADWAY, BROOKLYN, and TANDEM trials showing LDL-C reductions up to 40-50% vs placebo.","European Commission final decision expected in 2H26; if approved, authorization applies across EU plus Iceland, Liechtenstein, Norway.","Menarini holds exclusive European commercialization rights; NewAmsterdam eligible for tiered double-digit royalties and up to €833M in milestones."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-315163","json":"https://secwatch.observer/filing/0001193125-26-315163.json","markdown":"https://secwatch.observer/filing/0001193125-26-315163.md","text":"https://secwatch.observer/filing/0001193125-26-315163.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1936258/000119312526315163/0001193125-26-315163-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1936258/000119312526315163/nams-20260724.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-24T12:05:07.228481+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"}