NewAmsterdam Pharma Company N.V. announced that the European Medicines Agency accepted marketing authorization applications for obicetrapib and the fixed-dose combination of obicetrapib plus ezetimibe. The company had $756.0 million in cash, cash equivalents, and marketable securities as of September 30, 2025. Clinical trials and future milestones were also discussed, highlighting the potential of obicetrapib in treating cardiovascular disease.
In recent publications, the BROOKLYN and BROADWAY trials showed promising results related to cardiovascular outcomes and Alzheimer’s disease. NewAmsterdam Pharma is focused on developing obicetrapib as a novel therapy for patients at risk of cardiovascular disease. The company presented pooled efficacy and safety data from pivotal trials at the European Society of Cardiology Congress in August 2025.
NewAmsterdam plans to present additional data from ongoing Phase 3 trials, including the PREVAIL cardiovascular outcomes trial and the REMBRANDT imaging trial. The company also expects to initiate the RUBENS Phase 3 trial to evaluate obicetrapib in combination with ezetimibe for patients with type 2 diabetes or metabolic syndrome. Corporate updates include acceptance of marketing authorization applications by the European Medicines Agency for obicetrapib and the fixed-dose combination.
Financial results for the third quarter of 2025 were also provided, showing $756.0 million in cash, cash equivalents, and marketable securities. Revenue for the quarter was $0.3 million, with research and development expenses totaling $31.0 million. The company’s net loss for the quarter was $72.0 million, compared to $16.6 million in the same period in 2024.
NewAmsterdam Pharma is developing obicetrapib, a novel CETP inhibitor, as a potential LDL-lowering therapy for patients at risk of cardiovascular disease. The company aims to address the significant unmet need for safe and effective treatments for patients with metabolic diseases. Clinical trials and strategic partnerships with Menarini Group are key components of NewAmsterdam’s mission to improve patient care in these populations.
Read more at GlobeNewswire: NewAmsterdam Pharma Provides Corporate Update and Reports