NewAmsterdam Pharma wins first EU approval for obicetrapib

The Dutch biotech secured EC marketing authorisation for two obicetrapib products and dosed the first patient in a Phase 2b Alzheimer's trial.

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A brightly lit, modern medical imaging room features a large white MRI or CT scanner with a patient examination table, two computer monitors displaying medical scans, and medical carts visible in the background.

NewAmsterdam Pharma has secured the first regulatory approval anywhere in the world for its CETP inhibitor obicetrapib, after the European Commission granted marketing authorisation for both a monotherapy formulation and a fixed-dose combination product in September 2026.

The approvals cover Ubeslo, a 10 mg obicetrapib monotherapy, and Evlarco, a fixed-dose combination of 10 mg obicetrapib with 10 mg ezetimibe. Both are indicated for adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia and mixed dyslipidaemia. The EC decision followed a positive opinion from the EMA's Committee for Medicinal Products for Human Use and was supported by data from the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which the company said demonstrated LDL-C reductions of up to 40% with monotherapy versus placebo and approximately 50% with the combination versus placebo, with a tolerability profile comparable to placebo.

Commercial launch and partner milestones

Under a licensing agreement struck with Italian pharmaceutical group Menarini, NewAmsterdam holds no direct commercialisation responsibility in Europe. Menarini has exclusive rights across the region and plans to launch Ubeslo and Evlarco in Germany before the end of 2026, with a UK launch targeted for 2027. NewAmsterdam is entitled to tiered royalties in the low double-digits to mid-twenties on European net sales, plus up to an additional €817 million in clinical, regulatory and commercial milestone payments. The company recognised $19.2 million in revenue in the third quarter of 2026, up sharply from $0.3 million in the same period of 2025, primarily from regulatory milestones triggered under the Menarini agreement.

The company held $643.1 million in cash, cash equivalents and marketable securities at 30 September 2026, compared with $728.9 million at year-end 2025. The net loss for the quarter narrowed to $17.4 million from $72.0 million in Q3 2025, with the year-on-year improvement largely driven by a non-cash gain on the fair value of derivative warrant liabilities. R&D spending rose to $39.4 million from $31.0 million as clinical activity across the obicetrapib programme intensified.

Outcomes trial and Alzheimer's expansion

The most closely watched near-term catalyst is PREVAIL, a cardiovascular outcomes trial in more than 9,500 patients with atherosclerotic cardiovascular disease whose LDL-C remains inadequately controlled on maximally tolerated therapy. NewAmsterdam expects to reach the predefined event number for a planned interim analysis in Q4 2026, with results anticipated in Q1 2027. Chief executive Michael Davidson described PREVAIL as "the first cardiovascular outcomes trial evaluating a CETP inhibitor in more than a decade," a reference to the troubled history of the drug class: earlier CETP inhibitors from Pfizer, Roche and Eli Lilly all failed to show cardiovascular benefit, with torcetrapib actually associated with excess mortality.

Obicetrapib's differentiation rests on its selectivity and low-dose profile relative to predecessors, though that thesis will only be validated by PREVAIL's hard endpoint data. Additional Phase 3 readouts from RUBENS, which is evaluating the drug in type 2 diabetes and metabolic syndrome, are also expected around year-end 2026.

Beyond cardiovascular disease, NewAmsterdam dosed the first participant in SPINOZA in September 2026, a Phase 2b trial in approximately 400 people with preclinical Alzheimer's disease who carry ApoE4-related genotypes. The rationale draws on a prespecified biomarker sub-analysis from BROADWAY that showed statistically significant reductions in p-tau217, a key Alzheimer's pathology marker, over 12 months. The company is positioning SPINOZA as a proof-of-concept study; any therapeutic signal in neurodegeneration would significantly broaden the commercial narrative for obicetrapib beyond the already competitive LDL-lowering market, where PCSK9 inhibitors and inclisiran have established strong positions among statin-intolerant patients.

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