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

NewAmsterdam Pharma Co N.V.

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.

Featured in Daily 8-K Digest

Selected #5 for 2026-09-21. Read digest

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.