NewAmsterdam's obicetrapib wins first approvals in Europe, triggering a milestone payment
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The European Commission authorized two obicetrapib cholesterol treatments, marking the drug's first regulatory approvals worldwide, NewAmsterdam Pharma said in a Form 8-K filed Monday afternoon.
The decisions cover Ubeslo, a 10-milligram obicetrapib tablet, and Evlarco, a fixed-dose tablet combining 10 milligrams each of obicetrapib and ezetimibe. Both are approved for adults with primary hypercholesterolaemia or mixed dyslipidaemia. The authorizations extend across the European Union, Iceland, Liechtenstein and Norway.
Menarini holds the European commercialization rights. NewAmsterdam said the approvals trigger milestone payments in the mid-teens of millions of euros. Its licensing agreement also provides tiered royalties from the low double digits to the mid-twenties on net sales and up to another €833m in clinical, regulatory and commercial milestones.
One obligation remains. NewAmsterdam must submit final results from PREVAIL, its cardiovascular outcomes trial, as a post-authorization efficacy study.
The document: NewAmsterdam Pharma, Form 8-K, September 21, 2026.
