NewAmsterdam Pharma Co N.V.

NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) is a late-stage biopharmaceutical company focused on developing therapies for cardiometabolic diseases. The company's primary asset is obicetrapib, an oral, low-dose, once-daily cholesteryl ester transfer protein (CETP) inhibitor designed to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH). The company is developing obicetrapib both as a monotherapy and as a fixed-dose combination with ezetimibe.

NewAmsterdam's clinical development program includes multiple Phase 3 trials. The BROADWAY and BROOKLYN trials evaluated obicetrapib monotherapy as an adjunct to high-intensity statin therapy, with both studies meeting their primary endpoints and demonstrating statistically significant LDL-C reductions of 33% and 36% respectively compared to placebo. The TANDEM trial evaluated the fixed-dose combination of obicetrapib and ezetimibe, achieving a 52% mean LDL-C reduction compared to placebo. The company is also conducting PREVAIL, a Phase 3 cardiovascular outcomes trial designed to assess obicetrapib's potential to reduce major adverse cardiovascular events in approximately 9,000 patients.

Beyond cardiovascular indications, NewAmsterdam is exploring obicetrapib's potential in Alzheimer's disease and Type 2 diabetes based on preclinical evidence and biomarker analyses suggesting CETP inhibition may mitigate disease risk in these populations. The company has partnered with A. Menarini International Licensing S.A. for commercialization rights in most European countries, with marketing authorization applications accepted for review by the European Medicines Agency, United Kingdom, and Swiss regulators. NewAmsterdam intends to pursue development and commercialization of obicetrapib in the United States independently while evaluating additional partnerships for other jurisdictions including Japan and China. The company's website is www.newamsterdampharma.com.