---
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"
generated_at: "2026-05-17T12:07:47.096018+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# EMA validates MAA for NewAmsterdam's obicetrapib monotherapy and FDC with ezetimibe

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-109567
- JSON: https://secwatch.observer/filing/0000950170-25-109567.json
- Plain text: https://secwatch.observer/filing/0000950170-25-109567.txt

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