NewAmsterdam Pharma Company (NAMS) RBC Capital Markets Global Healthcare Conference 2026 summary

PREVAIL trial design and updates

• PREVAIL and BROADWAY trials were designed with similar inclusion criteria, targeting high-risk patients with elevated LDL for optimal LDL-lowering benefits.

• The primary endpoint was updated from an older 4-point MACE to a newer, more widely adopted definition, increasing event capture by including total revascularizations.

• The trial's power was increased to detect a 15% relative risk reduction with over 90% power, requiring more events and longer follow-up.

• Interim analysis is planned, with stopping criteria requiring significance in both 4-point and 3-point MACE to ensure robust results.

• Event rates in PREVAIL are tracking closely with BROADWAY initially, but a greater-than-expected decline in year two prompted adjustments.

Confidence in interim analysis and event rates

• Confidence in interim analysis is based on established LDL-event correlations, historical data, and similar patient populations in BROADWAY and REVEAL.

• Event rates for 3-point MACE are consistent with other major trials, and PREVAIL's first-year data closely matches BROADWAY.

• Drop-in rates for other therapies and dropout rates are low, supporting data integrity.

• The trial is designed to avoid early stopping unless both 3- and 4-point MACE are significant, ensuring academic and commercial credibility.

Regulatory and strategic considerations

• Close collaboration with the FDA has ensured all statistical plan changes are aligned with regulatory expectations.

• The goal is to have outcome data available at launch, positioning the drug as the first LDL-lowering therapy with outcome data at approval.

• Filing strategies around interim analysis are under consideration.