Core Insights - Menarini Group announced positive topline data from Phase 3 BROADWAY and TANDEM clinical trials, demonstrating the efficacy of Obicetrapib in reducing LDL-C levels significantly [1][17] - Obicetrapib achieved a 33% reduction in LDL-C compared to placebo in the BROADWAY trial, with a high statistical significance (p<0.0001) [4][15] - The fixed-dose combination of Obicetrapib and Ezetimibe in the TANDEM trial resulted in a 48.6% reduction in LDL-C compared to placebo, also with high statistical significance (p<0.0001) [10][11] 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][20] - The Menarini Group is an international pharmaceutical and diagnostics company with a turnover of $4.7 billion, focusing on therapeutic areas with high unmet needs [19] Clinical Trial Details - The BROADWAY trial involved 2,530 patients with established ASCVD and/or HeFH, evaluating the efficacy of 10 mg Obicetrapib as an adjunct to maximally tolerated lipid-lowering therapies [14][17] - The TANDEM trial included 407 patients and assessed the fixed-dose combination of Obicetrapib and Ezetimibe against monotherapy and placebo [16][17] Safety and Tolerability - Both BROADWAY and TANDEM trials reported that Obicetrapib was well tolerated, with safety profiles comparable to placebo [5][10] - The treatment discontinuation rates were 11.1% for Obicetrapib and 12.4% for placebo in the BROADWAY trial, indicating similar tolerability [7] Market Implications - The positive results from these trials may provide new treatment options for patients who do not achieve LDL-C targets with existing therapies, addressing a significant unmet need in cardiovascular care [13][20] - The development of Obicetrapib aligns with the growing demand for effective LDL-lowering therapies, particularly in populations with high cardiovascular risk [18][20]

Core Viewpoint - NewAmsterdam Pharma Company N.V. has successfully closed a public offering of ordinary shares and pre-funded warrants, raising approximately $452.6 million to support its development of oral, non-statin medicines for cardiovascular disease patients [1][2]. Group 1: Offering Details - The public offering included 14,667,347 ordinary shares priced at $24.50 each, with an additional 2,550,000 shares purchased through underwriters' options [1]. - Pre-funded warrants to purchase 4,882,653 ordinary shares were also offered at a price of $24.4999 each, reflecting a minimal exercise price [1]. - The total net proceeds from the offering, after deducting underwriting discounts and commissions, amounted to approximately $452.6 million [2]. Group 2: Company Background - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing therapies for patients with elevated low-density lipoprotein cholesterol (LDL-C) who are at risk of cardiovascular disease [6]. - The company is investigating obicetrapib, a once-daily CETP inhibitor, in multiple phase 3 studies as a potential LDL-C lowering therapy, either alone or in combination with ezetimibe [6].

NAARDEN, The Netherlands and MIAMI, Dec. 13, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “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 the closing of the previously announced underwritten public off ...

NAARDEN, the Netherlands and MIAMI, Dec. 11, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS; “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 the pricing of the previously announced underwritten public off ...

NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter Financial Results – Topline data from pivotal Phase 3 TANDEM trial now expected in 4Q 2024 due to faster than expected enrollment – – On-track to report topline data from pivotal Phase 3 BROADWAY trial in 4Q 2024 – – Strong balance sheet with $422.7 million in cash as of September 30, 2024 – Naarden, the Netherlands and Miami, USA; November 6, 2024 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or "NewAmsterdam" or the "Company"), a l ...

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 ...