NewAmsterdam Pharma Company (NAMS) Investor Day 2026 summary

Strategic and Scientific Updates

• PREVAIL trial is powered to detect a 15% relative risk reduction in MACE, with interim analysis in late 2024 and final readout in 2027, reflecting learnings from prior CVOTs and regulatory trends.

• BROADWAY and BROOKLYN phase III data showed a 21% relative risk reduction in MACE, supporting optimism for PREVAIL and informing event rate modeling.

• Obicetrapib, a CETP inhibitor, demonstrated robust LDL-C lowering (up to 41% as monotherapy, 61% in combination with ezetimibe), favorable safety, and outperformed prior CETP inhibitors.

• REMBRANDT (plaque regression) is fully enrolled, RUBENS (diabetes/metabolic syndrome) data expected by year-end, and SPINOZA (Alzheimer’s prevention) is set to launch with FDA-reviewed protocol.

• The company leverages AI for trial design and data analysis, aiming to stay at the forefront of scientific communication.

Market Opportunity and Commercial Outlook

• The lipid management market is expanding rapidly, with over 84 million diagnosed and 60 million undertreated patients in the US alone; non-statin and branded agents are growing at double-digit rates in US and EU.

• Updated guidelines and broader FDA labeling are driving more aggressive LDL-C targets, expanding the addressable patient pool for add-on therapies.

• Obicetrapib and its FDC with ezetimibe are positioned as differentiated, oral, once-daily therapies with strong efficacy, safety, and tolerability, targeting LDL, Lp(a), ApoB, and HDL.

• Early demand studies indicate high physician and patient interest, with 2 out of 3 HCPs likely to prescribe within 6 months of launch; Menarini will lead the EU launch, and US launch preparations are advanced.

• The company has secured $678M in cash, built a seasoned commercial team, and achieved key regulatory milestones, including positive CHMP opinion in Europe.

Clinical Differentiation and Future Directions

• Obicetrapib demonstrates robust LDL and Lp(a) lowering, significant HDL increase, and reduction in small dense LDL particles, with potential to reduce new-onset diabetes.

• REMBRANDT uses advanced CCTA imaging to assess plaque regression, aiming to support future labeling and promotion.

• RUBENS targets metabolic syndrome and diabetes, aiming to show LDL and small particle reduction in a high-risk population.

• SPINOZA will evaluate Alzheimer's prevention in high-risk APOE4 carriers, with p-tau217 as a key biomarker; FDA supports the trial design, and Alzheimer’s substudy showed significant reduction in p-tau217 progression.

• Genetic and clinical evidence supports CETP inhibition for reducing ASCVD, diabetes risk, and potentially Alzheimer’s disease progression.