NewAmsterdam reports positive CHMP opinion for obicetrapib, sets PREVAIL and RUBENS timelines
The company said an EMA committee backed marketing authorization for obicetrapib and its ezetimibe combination, while cash stood at $678.3 million as of June 30, 2026.
NewAmsterdam Pharma announced that in July 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination for patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidemia.1 A final decision from the European Commission is expected later this year.1
The company also outlined near-term trial timing. A PREVAIL interim analysis is planned for the fourth quarter of 2026, with results expected in the first quarter of 2027, and topline data from the RUBENS Phase 3 trial are expected by year-end 2026.1 PREVAIL, a cardiovascular outcomes trial, completed enrollment of over 9,500 patients in April 2024.1 The REMBRANDT Phase 3 trial completed enrollment of 323 patients in March 2026.1 RUBENS, initiated in December 2025, is evaluating obicetrapib alone or with ezetimibe in patients with type 2 diabetes or metabolic syndrome and is expected to enroll about 300 patients.1 Separately, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib for prevention of early Alzheimer's disease in 2026.1
On Alzheimer's biomarker data presented in July, the company reported that in a prespecified BROADWAY analysis, "prespecified analyses from the Phase 3 BROADWAY trial demonstrated statistically significant reductions in plasma p-tau217 versus placebo." A separate, previously presented pooled analysis of BROADWAY and BROOKLYN reported that obicetrapib was linked to a 23% reduction in major adverse cardiovascular events, with reductions in LDL-C and lipoprotein(a) jointly mediating 84.5% of the observed benefit, with the effect primarily attributable to LDL-C lowering and Lp(a) as an additional mediator.1
On finances, cash, cash equivalents and marketable securities totaled $678.3 million as of June 30, 2026, down from $728.9 million at December 31, 2025.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.