Core Viewpoint - NewAmsterdam Pharma has submitted Marketing Authorization Applications (MAAs) for obicetrapib monotherapy and its fixed-dose combination with ezetimibe to the European Medicines Agency (EMA) for treating primary hypercholesterolemia and mixed dyslipidemia, marking a significant step in providing new LDL-C lowering therapies for patients at risk of cardiovascular disease [1][2][3] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients with elevated low-density lipoprotein cholesterol (LDL-C) who are at risk of cardiovascular disease [1][6] - The company aims to address unmet needs in LDL-lowering therapies that are safe, well-tolerated, and convenient for patients [6] Product Development - Obicetrapib is a novel, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor, which has shown statistically significant LDL-C reductions in multiple Phase 3 trials, including BROADWAY, BROOKLYN, and TANDEM [2][5] - The BROADWAY trial reported a 33% reduction in LDL-C compared to placebo, while the TANDEM trial achieved a 49% reduction, demonstrating the efficacy of obicetrapib both as a monotherapy and in combination with ezetimibe [7] Partnership and Financials - NewAmsterdam has an exclusive licensing agreement with Menarini for the commercialization of obicetrapib in Europe, which includes an upfront payment of €115 million and potential milestone payments totaling up to €863 million [3][4] - The company is entitled to tiered double-digit percentage royalties on net sales in the Menarini territory, ranging from low double-digits to mid-twenties [1][3] Market Context - Cardiovascular disease remains the leading cause of death globally, with an estimated 17.9 million deaths annually, highlighting the need for effective LDL-lowering therapies [3] - Despite the availability of lipid-lowering therapies, many patients do not achieve their LDL-C targets, indicating a significant market opportunity for new treatments like obicetrapib [3][6]

Core Insights - NewAmsterdam Pharma will present full data from the Alzheimer's Disease biomarker analyses in the BROADWAY clinical trial at the Alzheimer's Association International Conference on July 30, 2025 [1] - The presentation will focus on the effects of Obicetrapib, a potent oral CETP inhibitor, on Alzheimer's Disease biomarkers in 1,727 patients with cardiovascular disease [2] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][6] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [6][7] Product Information - Obicetrapib is a novel, oral, low-dose CETP inhibitor developed by NewAmsterdam to improve LDL-lowering treatment outcomes [5] - The company has conducted multiple Phase 2 and Phase 3 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [5][7] - The Phase 3 PREVAIL cardiovascular outcomes trial, which began in March 2022, has enrolled over 9,500 patients to assess the potential of obicetrapib in reducing major adverse cardiovascular events (MACE) [5] Conference Details - The live webcast and conference call to review the full AD biomarker data will take place on July 30, 2025, at 10:00 a.m. ET [1][4] - The presentation will be led by Philip Scheltens, M.D., Ph.D., and will occur from 8:21 to 8:28 AM ET [2]

Company Overview - NewAmsterdam Pharma Company N.V. is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [1][5] - The company aims to address the unmet need for safe, well-tolerated, and convenient LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [5] R&D Day Announcement - NewAmsterdam will host an R&D Day event for analysts and investors on June 11, 2025, at 9:00 a.m. ET in New York City [1] - The event will feature key members of the management team, including the CEO and Chief Scientific Officer [2] Obicetrapib Development - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [4] - The company has conducted multiple Phase 2 and Phase 3 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [4] - The Phase 3 PREVAIL CVOT trial, which commenced in March 2022, has enrolled over 9,500 patients to assess obicetrapib's potential in reducing major adverse cardiovascular events (MACE) [4] Commercialization Rights - The commercialization rights for obicetrapib in Europe have been exclusively granted to the Menarini Group, a leading international pharmaceutical and diagnostics company [4]