LDL-lowering therapy
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NewAmsterdam Pharma Announces Three Presentations at the 2026 American College of Cardiology Annual Scientific Session
Globenewswire· 2026-03-23 12:00
Core Insights - NewAmsterdam Pharma is presenting data on obicetrapib, a novel oral low-dose therapy for hypercholesterolemia, at the American College of Cardiology Annual Scientific Session [1] Group 1: Presentation Details - The presentation titled "CETP Inhibition with Obicetrapib Preserved Kidney Function in Patients at High Cardiovascular Risk: Results from the BROADWAY Trial" will take place on March 28, 2026 [2] - Another presentation titled "Safety of Obicetrapib: An Integrated Pooled Phase III Safety Analysis" is scheduled for March 29, 2026 [2] - A third presentation titled "Cardiovascular Events in People with Normal Low-Density Lipoprotein Cholesterol Levels but Discordantly High Levels of Small/Medium LDL Particles" will occur on March 30, 2026 [2] Group 2: About Obicetrapib - Obicetrapib is a CETP inhibitor developed to address limitations of current LDL-lowering treatments, showing statistically significant LDL-lowering effects in multiple Phase 2 and Phase 3 trials [3] - The Phase 3 PREVAIL trial, assessing obicetrapib's potential to reduce major adverse cardiovascular events (MACE), completed enrollment with over 9,500 patients [3] - Commercialization rights for obicetrapib in Europe have been granted to the Menarini Group [3] Group 3: About NewAmsterdam - NewAmsterdam Pharma focuses on improving patient care for metabolic diseases where existing therapies are inadequate or poorly tolerated [4] - The company is investigating obicetrapib as a once-daily CETP inhibitor, either alone or in combination with ezetimibe, for patients at risk of cardiovascular disease [4]
NewAmsterdam Pharma Company (NasdaqGM:NAMS) FY Conference Transcript
2026-03-03 16:32
Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Event**: FY Conference on March 03, 2026 Key Industry Insights - **Market Size**: The unmet need for LDL-lowering therapies is significant, with an estimated 30 million patients requiring treatment. The latest data indicates that achieving LDL levels below 55 is crucial for reducing total mortality, expanding the target population for combination therapies [4][5] - **Lipid Market Growth**: The lipid market is experiencing substantial growth, particularly in the branded segment, driven by more aggressive treatment targets and guidelines. The introduction of oral therapies is expected to further accelerate this growth [10][11] Core Product Insights - **Obicetrapib**: NewAmsterdam's lead drug, obicetrapib, is positioned as a differentiated LDL-lowering therapy with several key benefits: - **LDL Reduction**: Comparable LDL reductions to injectable therapies, with a significant reduction in small LDL particles by 90% [6][14][45] - **HDL Increase**: A 150% increase in HDL levels, which is associated with a lower risk of diabetes and potential benefits in Alzheimer's disease prevention [6][14][19] - **Lp(a) Lowering**: A 50% reduction in Lp(a) levels, targeting a population that may not qualify for existing injectable therapies [7][36] Clinical Trial Highlights - **BROADWAY Trial**: Demonstrated a 21% MACE benefit at 12 months, with a consistent LDL-lowering effect. The trial's design aligns closely with the upcoming PREVAIL trial, which is expected to validate these findings [3][12][15][23] - **Future Trials**: The PREVAIL trial is anticipated to provide further evidence of obicetrapib's efficacy, with a focus on achieving a positive MACE benefit to ensure broad uptake among clinicians [21][30] Regulatory and Commercial Strategy - **European Launch**: NewAmsterdam plans to launch obicetrapib in Europe, with regulatory approval expected by the end of 2026. The partnership with Menarini is seen as advantageous for market entry and reimbursement strategies [21][61][63] - **Market Differentiation**: The company aims to position obicetrapib as the first Lp(a)-lowering therapy in Europe, which could enhance its competitive edge [60][61] Financial Insights - **Funding and Milestones**: NewAmsterdam has secured $730 million in financing, with expectations to achieve significant sales milestones through its partnership with Menarini [4][61] - **Market Potential**: The potential market for obicetrapib is vast, with estimates suggesting it could serve tens of millions of patients, especially as treatment guidelines evolve [79] Additional Considerations - **Alzheimer's Disease Focus**: The potential for obicetrapib to impact Alzheimer's disease is highlighted as a significant opportunity, with market research indicating strong motivation among patients for effective treatments [18][78] - **Diabetes Risk**: Unlike statins, obicetrapib has shown a reduction in the risk of new-onset diabetes, which is a critical differentiator in the LDL-lowering market [14][30] Conclusion NewAmsterdam Pharma is positioned to capitalize on the growing demand for effective LDL-lowering therapies through its innovative product, obicetrapib. The company's strategic focus on clinical validation, regulatory approval, and market differentiation is expected to drive its success in the competitive landscape of lipid management.
NewAmsterdam Announces Acceptance of Marketing Authorization Applications for Review by European Medicine Agency for Obicetrapib
GlobeNewswire News Room· 2025-08-18 12:00
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]
NewAmsterdam Pharma to Present Alzheimer’s Biomarker Data from BROADWAY Trial at AAIC 2025
Globenewswire· 2025-07-22 12:00
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]
NewAmsterdam Pharma to Host R&D Day on June 11, 2025
GlobeNewswire News Room· 2025-06-05 12:00
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]