NewAmsterdam Pharma (NAMS)

Executive Summary

NewAmsterdam Pharma is a clinical-stage biopharmaceutical company developing obicetrapib, a novel oral CETP inhibitor aimed at reducing LDL cholesterol in patients with uncontrolled hypercholesterolemia despite statin therapy. Its lead program targets a significant unmet need in cardiovascular disease (CVD), leveraging a mechanism that not only lowers LDL-C but also raises HDL-C and reduces Lp(a). The company's pivotal Phase 3 BROADWAY trial met its primary endpoint, demonstrating statistically significant LDL-C reduction versus placebo on top of maximally tolerated statins. A second Phase 3 trial (TANDEM) evaluating obicetrapib in combination with ezetimibe also achieved robust LDL-C lowering. These results position obicetrapib as a potential best-in-class oral therapy for residual cardiovascular risk, with a favorable safety profile and convenient once-daily dosing. The company has submitted a New Drug Application (NDA) to the FDA, expecting a decision in the second half of 2026. With a strong balance sheet and commercial partnerships, NewAmsterdam is poised to address a multi-billion-dollar market if approved.

Upcoming Catalysts (preview)

• Q2 2026FDA NDA submission for obicetrapib100% success
• Q3 2026FDA acceptance and Priority Review decision60% success
• TBDPhase 3 combination data with ezetimibe (TANDEM) detailed presentation90% success