NewAmsterdam Pharma Company (NAMS) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

Clinical trial updates and timelines

• PREVAIL and BROADWAY studies share similar design and event rates, supporting confidence in ongoing outcomes.

• PREVAIL update on timelines will be provided mid-year, based on continued adjudication of events out to at least two years.

• Design paper for PREVAIL is expected to be published within the year.

• Compliance in PREVAIL is strong, aided by site engagement and positive safety data from prior LDL studies.

• PREVAIL did not enrich for Lp(a); patient distribution mirrors general population, with 40% in the 50–150 range.

Drug profile and differentiation

• Obicetrapib achieves 70–80% of patients reaching risk-based goals, with a convenient oral format and strong safety profile.

• Demonstrates benefits beyond LDL reduction, including significant Lp(a) lowering, elimination of small LDL particles, and reduced diabetes incidence.

• Recent data suggest potential for Alzheimer's prevention or treatment.

• Only CETP inhibitor in late-stage development, with approval expected in Europe this year and U.S. regulatory timelines to be updated mid-year.

Market landscape and commercial strategy

• Market research shows strong resonance of obicetrapib’s profile among cardiologists and primary care physicians.

• Commercial team has experience launching in competitive markets and is confident in capturing significant share.

• U.S. launch strategy is tied to having outcomes data public at launch; Europe filing occurred earlier due to different pricing timelines.

• Sees opportunity in a large, underserved patient population, especially those not at risk-based goals despite treatment.