{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-109567","form_type":"8-K","ticker":"NAMS","cik":"0001936258","company_name":"NewAmsterdam Pharma Co N.V.","filed_at":"2025-08-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.643024+00:00","generated_at":"2026-05-17T12:07:47.096018+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"EMA validates MAA for NewAmsterdam's obicetrapib monotherapy and FDC with ezetimibe","bullets":["EMA will review Phase 3 BROADWAY, BROOKLYN and TANDEM trials supporting obicetrapib 10 mg and obicetrapib/ezetimibe FDC.","NewAmsterdam eligible for up to €863M in milestones and tiered double-digit to mid-twenties % royalties on Menarini territory net sales.","Obicetrapib monotherapy showed 33-36% LDL-C reduction vs placebo; FDC showed ~50% reduction in TANDEM trial.","MAA submitted by partner Menarini under exclusive license agreement signed June 2022."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-109567","json":"https://secwatch.observer/filing/0000950170-25-109567.json","markdown":"https://secwatch.observer/filing/0000950170-25-109567.md","text":"https://secwatch.observer/filing/0000950170-25-109567.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1936258/000095017025109567/0000950170-25-109567-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1936258/000095017025109567/nams-20250818.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T12:07:47.096018+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"}