NewAmsterdam Plans Prevail Interim Analysis in Fourth Quarter

The Tip Desk · November 10, 2026 · 3 min read

The company booked $19.2 million in revenue, primarily from Menarini regulatory milestones, and a $17.4 million net loss as it dosed SPINOZA and set a year-end RUBENS readout.

NewAmsterdam Pharma Company N.V. (NAMS), a late-stage clinical biopharmaceutical company developing oral CETP inhibitors for cardiovascular disease, said the European Commission granted marketing authorization in September for Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg), the first worldwide regulatory approval of obicetrapib.

The authorization covered primary hypercholesterolaemia, both heterozygous familial and non-familial or mixed dyslipidaemia, and followed a positive CHMP opinion in July. The company said the decision was supported by Phase 3 BROADWAY, BROOKLYN and TANDEM data showing LDL-C reductions of up to 40% with monotherapy versus placebo and about 50% with the ezetimibe combination, with tolerability comparable to placebo.

Under the Menarini licensing agreement, Menarini holds exclusive commercialization rights in Europe. NewAmsterdam is entitled to tiered royalties from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an additional €817 million on clinical, regulatory and commercial milestones. Menarini plans to launch into Germany by year-end 2026 and the UK in 2027.

For the quarter ended September 30, 2026, the company recognized $19.2 million in revenue, versus $0.3 million a year earlier, which it attributed primarily to recognition of certain regulatory milestones under the Menarini license.

Net loss narrowed to $17.4 million from $72.0 million in the same period of 2025. The company said the change reflected the items above plus interest income, a non-cash gain related to changes in the fair value of derivative warrant liabilities and foreign-exchange losses.

Research and development expenses were $39.4 million, versus $31.0 million a year earlier, which the company said was primarily due to higher clinical and personnel expenses, partially offset by lower regulatory and manufacturing expenses. Selling, general and administrative expenses were $24.0 million, versus $24.5 million, which it said was primarily due to lower personnel expenses, partially offset by higher commercial-readiness costs.

Cash, cash equivalents and marketable securities were $643.1 million at September 30, 2026, compared with $728.9 million at December 31, 2025. The company said the decrease was primarily driven by cash outflows related to research and development and selling, general and administrative spending, partially offset by inflows from the exercise of options and warrants.

In September 2026, NewAmsterdam dosed the first participant in SPINOZA, a Phase 2b trial evaluating obicetrapib in approximately 400 participants with preclinical Alzheimer’s disease. The design was informed by a prespecified Alzheimer’s biomarker analysis in BROADWAY, which the company said showed the strongest observed biomarker response in ApoE4/E4 participants.

The Phase 3 RUBENS trial completed enrollment of 347 patients in August 2026. Top-line data are expected around year-end 2026. REMBRANDT completed enrollment of 323 patients in March 2026.

PREVAIL, the cardiovascular outcomes trial in more than 9,500 patients, remains on a plan for an interim analysis in the fourth quarter of 2026, with the result expected in the first quarter of 2027. Chief Executive Officer Michael Davidson said the company anticipates reaching the predefined event number for that analysis in the fourth quarter.