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NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a late-stage clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated LDL-C. News about NewAmsterdam frequently centers on the clinical and regulatory progress of its lead investigational CETP inhibitor, obicetrapib, and related fixed-dose combination programs with ezetimibe.
Investors and clinicians following NAMS news can expect regular updates on NewAmsterdam’s Phase 3 development program, including the PREVAIL cardiovascular outcomes trial in patients with a history of atherosclerotic cardiovascular disease, the REMBRANDT imaging trial evaluating effects on coronary plaque and inflammation, and the RUBENS trial in patients with type 2 diabetes or metabolic syndrome who require additional LDL-C lowering. Press releases also cover pooled efficacy and safety data from pivotal trials such as BROOKLYN, BROADWAY and TANDEM, as presented at major cardiology and neurology conferences and in peer-reviewed journals.
Company news additionally includes regulatory milestones, such as acceptance of marketing authorization applications for obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination by the European Medicines Agency, as well as partnership activities with the Menarini Group in Europe and collaborations like the REMBRANDT imaging partnership with Caristo Diagnostics. Corporate updates on financial results, cash position, and equity-based inducement grants under Nasdaq Listing Rule 5635(c)(4) are also disclosed through press releases and SEC filings.
By monitoring NewAmsterdam Pharma news, readers can follow the evolution of obicetrapib’s clinical evidence in LDL-C lowering, cardiovascular outcomes, coronary plaque imaging and Alzheimer’s disease biomarkers, along with the company’s progress toward potential commercialization pathways and ongoing engagement with the investment and medical communities.
NewAmsterdam Pharma (Nasdaq: NAMS) reported third-quarter 2025 results and a corporate update focused on obicetrapib development and regulatory progress.
Key points: EMA accepted MAAs for obicetrapib 10 mg monotherapy and a 10/10 mg obicetrapib/ezetimibe FDC; pooled BROADWAY and BROOKLYN analyses were published in JACC and a BROADWAY Alzheimer’s substudy in Journal of Prevention of Alzheimer's Disease. Cash, cash equivalents and marketable securities were $756.0 million at September 30, 2025; Q3 revenue was $0.3M and net loss was $72.0M.
NewAmsterdam Pharma (Nasdaq: NAMS) will present additional safety and efficacy results from its pivotal Phase 3 BROOKLYN, BROADWAY and TANDEM trials at the 2025 American Heart Association Scientific Sessions in New Orleans, November 7–10, 2025.
Oral presentation: ‘‘CETP Inhibition with Obicetrapib Produces Substantial Reductions in LDL Particles: Pooled Analysis of BROOKLYN and BROADWAY’’ by John Kastelein on Nov 9, 2025 at 10:15am CT. Digital poster: obicetrapib plus ezetimibe data by Jose Inia on Nov 10, 2025 at 10:59am CT. Management will join three investor conference fireside chats Nov 11–19, 2025, with live webcasts and archived replays on the company IR site.
Caristo Diagnostics was chosen as the worldwide imaging core lab for NewAmsterdam Pharma (NASDAQ: NAMS) REMBRANDT Cardiovascular Imaging Trial announced Oct 14, 2025. Caristo will oversee all coronary plaque and inflammation measurements and monitoring across the study.
REMbrandT is a placebo-controlled, double-blind, randomized trial recruiting at 50 sites in 7 countries to assess obicetrapib+ezetimibe FDC. The primary endpoint is percent change in total noncalcified coronary atherosclerotic plaque volume (NCPV) at 18 months. Secondary endpoints include percent change in LDL-C and change in Caristo's proprietary FAI-Score for coronary inflammation.
NewAmsterdam Pharma (NASDAQ:NAMS), a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for cardiovascular disease patients, has announced its participation in the Stifel 2025 Virtual Cardiometabolic Forum.
The company's Chief Scientific Officer, John Kastelein, and EVP of Investor Relations, Matthew Philippe, will engage in a virtual fireside chat on September 30, 2025, at 11:00 a.m. ET. Investors can access the live webcast through NewAmsterdam's investor relations website, with an archived replay available afterward.
NewAmsterdam Pharma (NASDAQ: NAMS), a late-stage biopharma company focused on developing oral, non-statin medicines for cardiovascular disease patients, has announced its participation in multiple scientific and investor events in September 2025.
The company will present pooled safety and efficacy data from its Phase 3 BROADWAY and BROOKLYN trials for obicetrapib at the European Society of Cardiology Congress in Madrid. Additionally, management will participate in three investor conferences: Citi's Biopharma Back to School Summit, Cantor Global Healthcare Conference, and Wells Fargo Healthcare Conference.
[]NewAmsterdam Pharma (NASDAQ:NAMS) and Piramal Pharma Solutions announced the opening of a dedicated oral solid dosage (OSD) manufacturing suite at Piramal's Sellersville, Pennsylvania facility. The multi-million-dollar investment aims to enhance production capabilities for NewAmsterdam's fixed dose combination (FDC) of obicetrapib and ezetimibe, a non-statin cholesterol medication.
The new suite features advanced capabilities for granulation, compression, tableting, and coating, specifically designed for multi-layer tablet production. The collaboration extends beyond Sellersville, with support from Piramal's facilities in Ahmedabad and Pithampur, India. The investment is expected to create over 20 new jobs at the Sellersville site over the next five years.
NewAmsterdam Pharma (NASDAQ:NAMS) announced that the European Medicines Agency (EMA) has validated Marketing Authorization Applications for obicetrapib, both as a 10mg monotherapy and as a fixed-dose combination with ezetimibe. The applications, submitted by partner Menarini, target adults with primary hypercholesterolemia or mixed dyslipidemia.
The submissions are supported by three pivotal Phase 3 trials: BROADWAY, BROOKLYN, and TANDEM, which demonstrated LDL-C reductions of 35-40% for obicetrapib monotherapy and approximately 50% when combined with ezetimibe versus placebo. Under the partnership agreement, NewAmsterdam is eligible for up to €833 million in milestone payments and tiered double-digit royalties ranging from low double-digits to mid-twenties on net sales in Menarini's territory.
NewAmsterdam Pharma (NASDAQ: NAMS) reported Q2 2025 financial results and provided updates on its lead candidate obicetrapib. The company ended Q2 with $783.3 million in cash, reporting revenue of $19.1 million and a net loss of $17.4 million.
Key clinical developments include positive data from the BROADWAY and TANDEM trials, published in The New England Journal of Medicine and The Lancet respectively. Notably, BROADWAY's Alzheimer's disease analysis showed obicetrapib significantly reduced plasma p-tau217 levels versus placebo, with a 20.5% reduction in ApoE4/E4 carriers.
The company's European marketing authorization application is on track for 2H25, while the PREVAIL Phase 3 cardiovascular outcomes trial continues with over 9,500 patients enrolled. NewAmsterdam is also preparing to launch the Phase 3 RUBENS trial to evaluate obicetrapib with ezetimibe in type 2 diabetes patients.
NewAmsterdam Pharma (NASDAQ: NAMS) has announced positive data from its BROADWAY trial, demonstrating significant reductions in Alzheimer's disease biomarkers. The trial showed that obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's biomarker, in both the full analysis set (p=0.0019) and ApoE4 carriers (p=0.0215).
Most notably, in APOE4/E4 carriers, who face the highest risk for Alzheimer's, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo (p=0.010). The study included 1,515 patients, with 367 being ApoE4 carriers. Additional biomarkers including NFL, GFAP, p-tau181, and Aβ42/40 ratio also showed favorable trends, particularly in carriers of two E4 proteins.
These results complement obicetrapib's established cardiometabolic benefits, suggesting potential as a dual-action therapy for both cardiovascular and neurodegenerative conditions.
NewAmsterdam Pharma (Nasdaq: NAMS) announced it will present comprehensive Alzheimer's Disease (AD) biomarker data from its BROADWAY clinical trial at the Alzheimer's Association International Conference (AAIC) on July 30, 2025 in Toronto.
The presentation will focus on the effects of Obicetrapib, an oral CETP inhibitor, on Alzheimer's Disease biomarkers in 1,727 patients with cardiovascular disease. The company will host a webcast at 10:00 a.m. ET featuring distinguished speakers including Dr. Philip Scheltens, Dr. Kellyann Niotis, and Dr. Nathaniel Chin to discuss the findings.