NewAmsterdam Pharma reports Q1 results, keeps obicetrapib regulatory and Phase 3 timelines

NewAmsterdam Pharma reported first-quarter 2026 financial results and a corporate update as decisions on regulatory approval from EMA, UK, and Switzerland for obicetrapib and the obicetrapib/ezetimibe fixed-dose combination remain expected in the second half of 2026. The company said, based on the outcomes, potential launches by Menarini could begin in the fourth quarter of 2026 in Germany and the UK, while a PREVAIL interim analysis is planned for the fourth quarter of 2026 with result expected in the first quarter of 2027.

The company said it completed enrollment in REMBRANDT and expects topline data from the RUBENS Phase 3 trial by year-end 2026. It said PREVAIL continues to advance and that an initial blinded review of PREVAIL data after the two-year anniversary of enrollment completion showed a Year 1 overall MACE event rate consistent with BROADWAY and a Year 1-to-Year 2 overall MACE event rate lower than expected. The interim analysis timing coincides with the minimum 2.5-year follow-up for the trial, and if the trial does not stop for efficacy at that time, completion is anticipated by the end of 2027.

NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (CETP) inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe for patients at risk of cardiovascular disease with elevated LDL-C for whom existing therapies are not sufficiently effective or well-tolerated.

In March 2026, the company presented results from additional analyses of its pivotal Phase 3 BROADWAY and BROOKLYN trials at the American College of Cardiology Annual Scientific Session and simultaneously published them in the American Journal of Preventive Cardiology. Reported data included a pooled analysis showing that CETP inhibition with obicetrapib 10 mg was associated with a slower annualized decline in estimated glomerular filtration rate, at -0.41 vs. -1.08 with placebo, a difference of 0.67 mL/min/1.73 m², in patients with high cardiovascular risk.

The company also said patients treated with obicetrapib had nominally fewer composite renal events over 12 months, consisting of death due to cardiovascular or renal causes, eGFR below 15 mL/min/1.73 m² post-baseline, a 40% or greater decline in eGFR from baseline, kidney transplant, or dialysis initiation. A pooled Phase 3 safety analysis from BROOKLYN and BROADWAY continued to reinforce the safety and tolerability profile of obicetrapib, and findings showed that higher small/medium LDL particle discordance was independently associated with incident major adverse cardiovascular events, specifically in patients with high cardiometabolic burden.

The company reiterated that approval decisions from European, UK and Swiss regulators for obicetrapib 10 mg monotherapy and the 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination are expected in the second half of 2026. It previously said the marketing authorization applications were accepted for review for patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidemia.

Cash, cash equivalents and marketable securities were $707.3 million at March 31, 2026, compared with $728.9 million at December 31, 2025.