Core Insights - NewAmsterdam Pharma is advancing its clinical and regulatory efforts for obicetrapib, with expected approval decisions from EMA, UK, and Switzerland regulators in the second half of 2026 [1][2] - The company reported a cash position of $728.9 million as of December 31, 2025, indicating financial strength to support ongoing operations and potential commercial launch [1][2] Clinical Development and Regulatory Updates - NewAmsterdam is developing obicetrapib as a low-dose, oral CETP inhibitor for patients at risk of cardiovascular disease (CVD) [3][10] - Marketing Authorization Applications (MAAs) for obicetrapib and its fixed-dose combination with ezetimibe have been accepted for review by EMA, UK, and Switzerland [2][3] - The company is preparing for a potential commercial launch in Europe alongside its partner Menarini [2][3] - Ongoing Phase 3 trials include PREVAIL, REMBRANDT, and RUBENS, with topline data from RUBENS expected by year-end 2026 [2][8] Financial Performance - NewAmsterdam reported a revenue of $22.5 million for the year ended December 31, 2025, a decrease from $45.6 million in 2024 [6][21] - Research and Development (R&D) expenses were $141.8 million in 2025, down from $151.4 million in 2024, primarily due to the completion of several Phase 3 trials [9][21] - Selling, General and Administrative (SG&A) expenses increased to $106.4 million in 2025 from $70.4 million in 2024, driven by higher personnel and marketing costs [13][21] Alzheimer's Disease Analysis - Positive data from the BROADWAY trial indicated significant reductions in p-tau217, a key Alzheimer's disease biomarker, supporting a link between CETP inhibition and neurodegeneration [7][12] - The analysis included 1,535 patients, with notable results in ApoE4 carriers, showing a 20.5% reduction in p-tau217 levels over 12 months compared to placebo [7][12][14] Upcoming Milestones - NewAmsterdam plans to announce additional data from its ongoing Phase 3 trials in 2026, including the potential initiation of a new clinical trial for obicetrapib in early Alzheimer's disease patients [5][8]