NewAmsterdam Pharma Highlights 2025 Achievements and Outlines 2026 Strategic Priorities

Core Insights - NewAmsterdam Pharma is advancing its clinical development program for obicetrapib, an oral CETP inhibitor, with EMA approval expected in the second half of 2026 [1][3][5] - The company is conducting multiple Phase 3 trials, including PREVAIL, REMBRANDT, and RUBENS, to evaluate the efficacy of obicetrapib in various patient populations [3][6] - NewAmsterdam reported a year-end cash balance of approximately $729 million, which is expected to support operations through anticipated clinical milestones [7] Clinical Development - Obicetrapib is being developed as a low-dose, once-daily therapy for patients with elevated LDL-C who are at risk of cardiovascular disease [2][12] - The PREVAIL trial is tracking overall MACE event rates in line with the BROADWAY trial, indicating promising results for cardiovascular outcomes [3][4] - The RUBENS trial has enrolled its first patients and aims to evaluate obicetrapib in patients with metabolic syndrome [1][3] Regulatory and Commercialization Plans - NewAmsterdam is preparing for a potential commercial launch in Europe, contingent upon EMA approval for obicetrapib and its fixed-dose combination with ezetimibe [3][5] - The company has submitted marketing authorization applications (MAAs) for both obicetrapib monotherapy and the fixed-dose combination [5] Financial Position - As of December 31, 2025, NewAmsterdam's cash, cash equivalents, and marketable securities balance is approximately $729 million, which is projected to be sufficient for ongoing operations and potential commercialization [7] Alzheimer's Disease Research - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key biomarker for Alzheimer's disease, suggesting a link between CETP inhibition and neurodegeneration [4][11] - NewAmsterdam plans to initiate a dedicated Alzheimer's trial in 2026 based on encouraging biomarker analysis results [3][6]