NewAmsterdam Pharma and Menarini receive positive CHMP opinion for obicetrapib products in Europe

NewAmsterdam Pharma Co N.V.

CHMP recommends marketing authorization for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib/ezetimibe FDC) for hypercholesterolemia.
Recommendation based on Phase 3 BROADWAY, BROOKLYN, and TANDEM trials showing LDL-C reductions up to 40-50% vs placebo.
European Commission final decision expected in 2H26; if approved, authorization applies across EU plus Iceland, Liechtenstein, Norway.
Menarini holds exclusive European commercialization rights; NewAmsterdam eligible for tiered double-digit royalties and up to €833M in milestones.

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