NAARDEN, The Netherlands and MIAMI, Oct. 28, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ("CVD") with elevated low-density lipoprotein cholesterol ("LDL-C"), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it will present additional safety and efficacy data from ...

NAARDEN, The Netherlands and MIAMI, Aug. 30, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ("CVD") with elevated low-density lipoprotein cholesterol ("LDL-C"), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that company management will participate in the following upc ...

Needham has initiated coverage on NewAmsterdam Pharma Company N.V NAMS, a clinical-stage biopharma developing obicetrapib, an orally-dosed CETP inhibitor for lowering cholesterol. In July, NewAmsterdam Pharma released topline data from the Phase 3 BROOKLYN trial, the first of four studies in NewAmsterdam's pivotal clinical development program, to evaluate obicetrapib in adult patients with heterozygous familial hypercholesterolemia whose LDL-C is not adequately controlled, despite being on maximally tolerat ...

Core Insights - NewAmsterdam Pharma announced positive topline data from the Phase 3 BROOKLYN clinical trial, demonstrating significant LDL-C reduction in patients with heterozygous familial hypercholesterolemia (HeFH) [1][2][11] Group 1: Clinical Trial Results - The BROOKLYN trial achieved its primary endpoint with a statistically significant LS mean reduction in LDL-C of 36.3% at day 84 and 41.5% at day 365 compared to placebo (p < 0.0001) [2][3] - 51% of patients treated with obicetrapib achieved LDL-C levels below 70 mg/dL [3] - The treatment was well-tolerated, with a discontinuation rate of 7.6% for obicetrapib compared to 14.4% for placebo [4][5] Group 2: Safety and Tolerability - Safety results for obicetrapib were comparable to placebo, with no increase in blood pressure or significant differences in liver enzymes, hs-CRP, or renal function [5][12] - The incidence of treatment-emergent adverse events (TEAEs) was 63.7% for obicetrapib compared to 70.3% for placebo [4] Group 3: Future Developments - NewAmsterdam plans to present full results from the BROOKLYN trial at a medical conference and publish the data in a major medical journal [6] - The company is conducting additional pivotal trials, including BROADWAY and TANDEM, with topline data expected in late 2024 and early 2025, respectively [11][12] Group 4: Company Overview - NewAmsterdam Pharma focuses on developing oral, non-statin therapies for patients at risk of cardiovascular disease, particularly those with elevated LDL-C levels who have not responded adequately to existing treatments [1][13] - The company aims to address the unmet need for effective LDL-lowering therapies in populations with metabolic diseases [13]

NAARDEN, the Netherlands and MIAMI, July 26, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ("CVD") with elevated low-density lipoprotein cholesterol ("LDL-C"), for whom existing therapies are not sufficiently effective or well-tolerated, today announced it will report topline data from the Company's Phase 3 BROOKL ...

Core Insights - NewAmsterdam Pharma is set to report topline data from its Phase 3 BROOKLYN clinical trial on July 29, 2024, focusing on oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C levels [1][2] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company dedicated to improving patient care in populations with metabolic diseases where existing therapies are inadequate or poorly tolerated [5] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, either alone or in combination with ezetimibe, as a therapy to lower LDL-C levels for patients at risk of cardiovascular disease [5]

Core Insights - NewAmsterdam Pharma has completed enrollment in the pivotal Phase 3 TANDEM trial, which is a significant milestone in the development of obicetrapib, a CETP inhibitor aimed at treating dyslipidemia [1][6] - The company is encouraged by positive enrollment trends in four ongoing pivotal Phase 3 studies, indicating strong interest from physicians and patients [1][2] - The TANDEM trial aims to evaluate the fixed-dose combination of obicetrapib and ezetimibe in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) [6][7] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin therapies for patients at risk of cardiovascular disease with elevated LDL-C levels [3][10] - The company aims to address unmet needs for safe and well-tolerated LDL-lowering therapies [3] Clinical Trials - The TANDEM trial enrolled 407 patients with a baseline LDL-C of at least 70 mg/dL, evaluating the effect of a fixed-dose combination of obicetrapib and ezetimibe on LDL-C levels [7] - The trial's primary objective is to compare the LDL-C lowering effects of the combination therapy against monotherapy and placebo [7] - NewAmsterdam is also conducting two other pivotal Phase 3 trials, BROADWAY and BROOKLYN, to assess obicetrapib as a monotherapy and in combination with other lipid-lowering therapies [2][6] Market Potential - Cardiovascular disease remains a significant global health issue, with many patients unable to achieve target LDL-C levels despite existing therapies [2] - Obicetrapib has shown promise in previous Phase 2 trials, demonstrating statistically significant LDL-lowering effects with a side effect profile similar to placebo [2][6] - The company anticipates sharing topline data from the TANDEM study in the first quarter of 2025, which could influence its market positioning [1]

Core Insights - NewAmsterdam Pharma has completed patient enrollment in the pivotal Phase 3 TANDEM clinical trial for obicetrapib plus ezetimibe, targeting patients with Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) [1][2] - The trial enrolled 407 patients with a baseline LDL-C of at least 70 mg/dL, aiming to evaluate the efficacy of the fixed-dose combination in lowering LDL-C levels compared to monotherapy and placebo [2][4] - The company anticipates sharing topline data from the TANDEM study in the first quarter of 2025, reflecting a positive trend in physician and patient interest in their clinical trials [2][3] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease, particularly those with elevated LDL-C levels [1][5] - The company is conducting multiple Phase 3 trials, including BROADWAY, BROOKLYN, and PREVAIL, to assess the efficacy of obicetrapib as a monotherapy and in combination with ezetimibe [4][6] - Obicetrapib is a novel, low-dose CETP inhibitor designed to provide a safe and effective LDL-lowering therapy for patients who do not respond adequately to existing treatments [4][6]

Core Insights - NewAmsterdam Pharma is presenting new clinical data on obicetrapib, a novel oral low-dose therapy for hypercholesterolemia, at upcoming scientific sessions in Europe and the U.S. [1][5] - The company is on track to report topline data from its Phase 3 BROOKLYN trial in HeFH in Q3 2024 and the BROADWAY trial in ASCVD in Q4 2024 [1] Clinical Trials and Presentations - NewAmsterdam will present findings from the OCEAN, ROSE, and ROSE2 Phase 2 clinical trials, showcasing obicetrapib's effects on lipid and lipoprotein biomarkers [1] - The EAS 92nd Congress will feature multiple presentations on obicetrapib, including its impact on HDL and Lp(a) levels, as well as its effects in combination with ezetimibe [2][3] - The NLA 2024 Scientific Sessions will also highlight obicetrapib's significant reductions in Lp(a) and its synergistic effects with ezetimibe [3][4] Product Development - Obicetrapib is being developed as a CETP inhibitor to address the limitations of current LDL-lowering treatments, with Phase 3 trials BROADWAY and BROOKLYN evaluating its efficacy as a monotherapy and in combination with other therapies [5][6] - The company has completed enrollment for the BROOKLYN and BROADWAY trials and is also conducting the PREVAIL trial to assess cardiovascular outcomes [5]

NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results -- Enrolled over 9,500 patients in Phase 3 PREVAIL global CVOT-- -- On-track to report topline data from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and Phase 3 BROADWAY trial in ASCVD in 4Q 2024 -- -- Dosed first patients in TANDEM, pivotal Phase 3 trial evaluating fixed-dose combination of obicetrapib and ezetimibe; topline data expected in 1Q 2025 -- -- Company to host R&D event on May 16, 2024, beginning at 9:00 a.m. ...