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]

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]

Core Insights - NewAmsterdam Pharma is focused on advancing obicetrapib, a novel oral therapy for lowering LDL-C in patients at risk of cardiovascular disease, with recent regulatory milestones achieved in Europe [2][7][11] Clinical Development Updates - The European Medicines Agency has accepted marketing authorization applications for obicetrapib and its fixed-dose combination with ezetimibe, marking a significant regulatory milestone [2][7] - Ongoing clinical trials include PREVAIL, a cardiovascular outcomes trial with over 9,500 patients enrolled, and REMBRANDT, a Phase 3 imaging trial [9][11] - Recent data from the BROADWAY trial indicates obicetrapib's potential to modify Alzheimer's disease biomarkers, particularly in high-risk patients [5][13] Financial Performance - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities totaling $756.0 million, a decrease from $834.2 million at the end of 2024 [10][21] - Revenue for the third quarter of 2025 was $0.3 million, down from $29.1 million in the same period in 2024, primarily due to the absence of clinical milestone revenue [10][23] - Research and development expenses decreased to $31.0 million from $35.7 million year-over-year, while selling, general, and administrative expenses increased to $24.5 million from $18.4 million [10][23] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals despite existing treatments [12][14] - The company aims to address this gap with obicetrapib, which has shown promising results in clinical trials, indicating its potential as a differentiated therapy in a growing market [2][11]

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 is advancing its oral, low-dose CETP inhibitor obicetrapib, targeting cardiovascular disease and Alzheimer's pathology, with significant clinical data supporting its efficacy [3][4][10] - The company reported a substantial increase in revenue for Q2 2025, recognizing $19.1 million compared to $2.3 million in Q2 2024, primarily due to development cost contributions from Menarini [7][19] - NewAmsterdam's cash position as of June 30, 2025, was $783.3 million, down from $834.2 million at the end of 2024, reflecting ongoing operating expenditures [7][19] Clinical Development Updates - The PREVAIL Phase 3 cardiovascular outcomes trial has completed enrollment of over 9,500 patients, focusing on those with a history of ASCVD [9][10] - Positive topline data from the BROADWAY trial indicated a statistically significant reduction in p-tau217 levels, a key Alzheimer's biomarker, in patients treated with obicetrapib [4][12] - The company plans to launch the Phase 3 RUBENS trial later in 2025, evaluating obicetrapib in combination with ezetimibe for patients with type 2 diabetes and metabolic syndrome [3][4] Financial Performance - NewAmsterdam reported a net loss of $17.4 million for Q2 2025, an improvement from a net loss of $39.0 million in Q2 2024 [7][19] - Research and development expenses decreased to $27.5 million in Q2 2025 from $38.4 million in the same period in 2024, attributed to reduced clinical expenses [7][19] - Selling, general, and administrative expenses rose to $27.3 million in Q2 2025, up from $16.5 million in Q2 2024, driven by increased personnel costs and marketing investments [7][19] Market Context - Cardiovascular disease remains a leading global health issue, with a projected increase in affected U.S. adults to over 184 million by 2050, highlighting the need for effective LDL-C lowering therapies [11] - Despite the availability of lipid-lowering therapies, many patients remain undertreated, with only 10% of very high-risk ASCVD patients achieving LDL-C goals below 55 mg/dL [11] - The company aims to address this unmet need with obicetrapib, which has shown promising LDL-C reduction and a favorable safety profile in clinical trials [10][11]

Core Insights - Obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's disease biomarker, in both the full analysis set and in ApoE4 carriers, indicating its potential as a novel approach to Alzheimer's prevention [1][3][12] - In ApoE4/E4 carriers, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo [1][4] - The results support obicetrapib's cardiometabolic profile, showing reductions in LDL-C and other cardiovascular risk factors [1][2] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][15] - The company aims to address unmet needs in populations where existing therapies are not sufficiently effective or well-tolerated [15] Clinical Trial Details - The BROADWAY trial was a pivotal Phase 3 study designed to evaluate the LDL-C lowering efficacy of obicetrapib in patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia [2][10] - A total of 2,530 patients were randomized to receive either 10 mg obicetrapib or placebo for 52 weeks, with the primary endpoint being the percent change in LDL-C [10][11] Biomarker Analysis - The prespecified analysis evaluated the effect of obicetrapib on plasma biomarkers of Alzheimer's disease in 1,515 patients, including 367 ApoE4 carriers [2][12] - Statistically significant reductions in p-tau217 were observed, with additional favorable trends in other biomarkers such as NFL and GFAP [3][4][12] Implications for Alzheimer's Disease - The findings suggest that upstream lipid modulation may influence Alzheimer's disease risk, particularly in ApoE4 carriers, who represent over 25% of the population [7] - Obicetrapib's ability to reduce multiple important AD biomarkers alongside its LDL-C lowering effects highlights its potential to address both neurodegenerative and cardiovascular disease risks [7][14]

Core Insights - NewAmsterdam Pharma is set to 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][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 low-density lipoprotein cholesterol [1][6] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [6] Product Information - Obicetrapib is a novel, oral, low-dose CETP inhibitor being developed by NewAmsterdam to improve LDL-lowering treatment outcomes [5] - The company has observed statistically significant LDL-lowering effects in multiple Phase 2 trials, with a side effect profile similar to that of placebo [5] - NewAmsterdam commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, enrolling over 9,500 patients [5] Upcoming Events - The presentation titled "Effects of Obicetrapib, a Potent Oral CETP Inhibitor, on Alzheimer's Disease Biomarkers in 1727 Patients with Cardiovascular Disease" will take place on July 30, 2025, at 8:21 AM ET [2] - A live webcast and conference call will be hosted by NewAmsterdam at 10:00 AM ET on the same day to review the full AD biomarker data [2][3]

Core Insights - NewAmsterdam Pharma announced positive topline data from the Phase 3 BROADWAY clinical trial, indicating that obicetrapib treatment leads to significant reductions in Alzheimer's disease biomarkers in both the full population and ApoE4 carriers [1][2][3] Group 1: Clinical Trial Details - The BROADWAY study was designed to evaluate the LDL-C lowering efficacy of obicetrapib in patients with established atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) [2][4] - The trial involved 2,530 patients randomized to receive either 10 mg obicetrapib or placebo for 52 weeks, with a mean baseline LDL-C of approximately 100 mg/dL [4][5] - The primary endpoint showed a 33% reduction in LDL-C after 84 days for the obicetrapib group compared to placebo [6] Group 2: Alzheimer's Disease Sub-Study - A pre-specified sub-study assessed the effects of obicetrapib on plasma biomarkers of Alzheimer's disease, including p-tau217, in 1,727 patients, with significant results in both the full population (p<0.002) and ApoE4 carriers (p=0.0215) [7] - The sub-study aimed to evaluate the impact of a 12-month therapy duration on AD biomarkers, indicating a potential to alter disease trajectory in ApoE4 carriers [3][7] Group 3: Implications and Future Plans - The findings suggest a potential preventive strategy for Alzheimer's disease, particularly for the 25% of the population carrying ApoE4 risk alleles [3] - NewAmsterdam plans to present full results from the AD sub-study at the Alzheimer's Association International Conference in July 2025 [1][3] Group 4: About Obicetrapib - Obicetrapib is a novel, oral, low-dose CETP inhibitor developed to address limitations of current LDL-lowering treatments, showing significant LDL-lowering effects in multiple trials [9][10] - The company has also initiated the Phase 3 PREVAIL cardiovascular outcomes trial, which has enrolled over 9,500 patients [9]

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]

Core Insights - NewAmsterdam Pharma is advancing its clinical development of obicetrapib, an oral, low-dose CETP inhibitor aimed at lowering LDL-C in patients at risk of cardiovascular disease (CVD) [4][14] - The company reported a cash position of $808.5 million as of March 31, 2025, indicating strong financial backing for ongoing and future projects [11][3] - NewAmsterdam plans to submit for EMA approval in the second half of 2025 through its partner Menarini, highlighting its regulatory progress [3][4] Financial Performance - For the first quarter of 2025, NewAmsterdam recognized $3.0 million in revenue, up from $1.4 million in the same period in 2024, primarily due to increased transaction prices related to R&D contributions from Menarini [11] - Research and Development (R&D) expenses increased to $44.8 million in Q1 2025 from $42.4 million in Q1 2024, driven by higher personnel costs and investments in pipeline expansion [11] - Selling, General and Administrative (SG&A) expenses rose significantly to $27.2 million in Q1 2025 from $14.5 million in Q1 2024, reflecting increased costs associated with the planned commercial launch of obicetrapib [11] Clinical Development Updates - NewAmsterdam is conducting several pivotal Phase 3 trials, including PREVAIL, which has enrolled over 9,500 patients to evaluate obicetrapib's impact on major adverse cardiac events (MACE) [5][10] - The company is also progressing with the VINCENT Phase 2 trial, assessing the effects of obicetrapib alone and in combination with evolocumab on lipoprotein (a) [5] - The REMBRANDT Phase 3 trial will evaluate the effect of obicetrapib plus ezetimibe on coronary plaque in high-risk ASCVD patients [6] Corporate Updates - NewAmsterdam appointed Adele Gulfo to its Board of Directors in April 2025, bringing over three decades of pharmaceutical experience [7] - The company will host an R&D Day on June 11, 2025, to discuss its research and development initiatives [8] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals with current treatments [13][14] - The company aims to address the needs of the approximately 30 million under-treated U.S. adults who are not at their risk-based LDL-C goal [13]