NewAmsterdam Pharma Announces EU Approval for Ubeslo® and Evlarco®

What Happened
On September 21, 2026, NewAmsterdam Pharma Company N.V. announced that the European Commission granted marketing authorization for Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (10 mg obicetrapib + 10 mg ezetimibe fixed‑dose combination) for patients with primary hypercholesterolaemia (including heterozygous familial) or mixed dyslipidaemia. These approvals cover all EU Member States, plus Iceland, Liechtenstein and Norway, and represent the first regulatory approvals of obicetrapib worldwide. The authorizations include standard post‑approval safety monitoring and require submission of final results from NewAmsterdam’s PREVAIL cardiovascular outcomes trial.

Key Details

• Date filed: 8‑K dated September 21, 2026; signatory: Mike Marino, Chief Legal Officer.
• Territories: EU Member States, Iceland, Liechtenstein, Norway.
• Commercial terms with Menarini: Menarini holds exclusive commercialization rights in Europe and handles regulatory and commercial activities.
• Financials: NewAmsterdam is entitled to tiered royalties in the low double‑digits to mid‑twenties on net sales in the Menarini Territory, plus up to €833 million in potential milestone payments; mid‑teens of millions are triggered by these EC authorizations.
• Post‑approval obligations: pharmacovigilance, risk‑minimization measures and a post‑authorization efficacy study requiring final PREVAIL trial results.

Why It Matters
This is a material regulatory milestone: it enables commercialization of obicetrapib products in Europe under Menarini’s license and creates near‑term royalty and milestone potential for NewAmsterdam. Investors should note the revenue model (royalties plus milestone payments) and the remaining regulatory requirement to deliver final PREVAIL outcomes data, which could affect long‑term uptake and obligations.