NewAmsterdam Pharma Company (NAMS) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Clinical development and data insights

• Obicetrapib reduces LDL by 35–40% as monotherapy and over 50% in fixed-dose combination, with a manageable safety profile and once-daily dosing.

• BROADWAY and BROOKLYN studies showed reduced incidence of diabetes, improved kidney function, and significant Lp(a) reduction.

• Blinded PREVAIL data closely tracks BROADWAY results, with declining event rates over time and lower-than-expected rates compared to contemporary studies.

• PREVAIL interim analysis is expected in Q1 next year, with final completion by year-end; statistical significance requires a p-value of 0.01 for four-point MACE.

• BROADWAY-like MACE reduction (~20%) is expected to achieve statistical significance at interim or final analysis.

Competitive landscape and strategic positioning

• Obicetrapib is the only CETP inhibitor among branded and in-development therapies, offering broader benefits beyond LDL reduction.

• Contemporary studies (VESALIUS-CV, ZEUS, HORIZON) are referenced for context, with LDL targeting still translating to outcomes benefit.

• The evolving therapeutic landscape, including GLP and PCSK9 therapies, is monitored for potential impact on event rates and market dynamics.

Commercialization plans and market strategy

• CHMP recommendation for European approval is expected to be followed by EMA approval, enabling Menarini to launch obicetrapib in Europe, starting with Germany and the UK.

• U.S. pricing strategy will be informed by European dynamics and launches of oral PCSK9s, with payer access and pricing models under close observation.

• Commercial team build-out is planned to be gradual, with a shift from R&D to commercial focus as clinical studies conclude by 2027.