---
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"
generated_at: "2026-09-21T20:31:42.031755+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# European Commission approves obicetrapib (Ubeslo/Evlarco) for hypercholesterolaemia; first approval worldwide

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-396716
- JSON: https://secwatch.observer/filing/0001193125-26-396716.json
- Plain text: https://secwatch.observer/filing/0001193125-26-396716.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.