NewAmsterdam Pharma Company (NAMS) Leerink Global Healthcare Conference 2026 summary

Recent clinical and regulatory progress

• Completed phase III trials (BROOKLYN, BROADWAY, TANDEM) showing strong LDL-lowering efficacy and good tolerability for obicetrapib, with European approval filing underway this year.

• BROADWAY mini outcome study (2,500 patients) demonstrated a 21% MACE benefit, supporting confidence in ongoing PREVAIL outcomes trial.

• PREVAIL trial, with 9,500 patients, is designed to maximize success and is on track for completion, with minimum follow-up ending around November.

• RUBENS diabetes trial aims to expand the label to include diabetic patients without heart disease, potentially increasing the eligible population by $20 million.

• VINCENT trial is evaluating Lp(a) lowering in combination with a PCSK9 inhibitor.

Commercial outlook and partnerships

• Anticipates European approval and commercial launch by Menarini, starting in Germany and the UK, with Europe expected to contribute 40-50% of global sales.

• Royalty agreement ranges from low double digits to mid-20%, with expectations to reach 20%+ as sales milestones are met.

• Approximately EUR 800 million in milestones remain, tied to approvals, launches, and sales thresholds.

• Market opportunity is estimated at $8 billion or higher, with significant growth expected as treatment guidelines evolve.

Competitive landscape and differentiation

• Obicetrapib offers oral administration, strong LDL and Lp(a) lowering, and favorable tolerability compared to injectables.

• Positioned as a go-to therapy for patients with high Lp(a) and LDL, especially those not yet diagnosed with heart disease.

• HORIZON trial outcomes for Novartis' Lp(a) agent seen as a win-win, with obicetrapib's benefits established regardless of HORIZON's results.

• Merck's oral PCSK9 may launch first in the US, but obicetrapib will launch in Europe with outcome data in hand, offering additional benefits such as diabetes risk reduction and small particle elimination.