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 ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41562 NewAmsterdam Pharma Company N.V. (Exact Name of Registrant as Specified in its Charter) The Netherlands N/A ( State or ...

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 ...