NewAmsterdam Pharma and Menarini Group announced on Monday, September 21, 2026 that the European Commission approved Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for adults with primary hypercholesterolemia, including heterozygous familial and non-familial forms, or mixed dyslipidemia. The companies called it the first regulatory approval of obicetrapib, an oral, low-dose CETP inhibitor, anywhere in the world. The approval cites the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which showed LDL-C reductions of up to 40% with obicetrapib alone and about 50% with the ezetimibe combination versus placebo, with tolerability comparable to placebo. Menarini holds exclusive European commercialization rights and pays NewAmsterdam tiered double-digit royalties, with up to €833 million more in milestones.
NewAmsterdam Pharma (NASDAQ: NAMS) presented obicetrapib CETP inhibitor Alzheimer's-prevention biomarker data at AAIC 2026 in London on Wednesday July 15, 2026 in a poster session (7:30 AM-4:30 PM BST at ICC Maritime Hall) titled 'CETP Inhibition for Alzheimer's Prevention: Obicetrapib's Multi-Pathway Effects on Lipid Mediated Pathophysiology' (Abstract 2026-A-5685-AAIC, Poster 0056). The Phase 3 BROADWAY cardiovascular-outcomes trial (obicetrapib as an oral, low-dose, once-daily CETP inhibitor adjunct to statin therapy) documented statistically significant reductions in absolute plasma p-tau217 versus placebo over 12 months. Full analysis set: n=1,535, p=0.025. In ApoE4 carriers (the highest-risk Alzheimer's-genetic subgroup): n=367, p=0.022. NewAmsterdam also reported favorable trends in other AD biomarkers. Obicetrapib's mechanism is CETP inhibition to raise HDL cholesterol and lower LDL, but the AD-biomarker signal supports a dual cardiovascular-plus-Alzheimer's-prevention thesis. Obicetrapib was well-tolerated in BROADWAY with safety comparable to placebo. NewAmsterdam is advancing obicetrapib toward regulatory filings on the LDL-C indication and is in EMA review with dual cardiovascular and neurology positioning.