other material
confidence high
sentiment positive
materiality 0.85
NewAmsterdam reports positive Phase 3 BROADWAY topline: 33% LDL-C reduction, 21% MACE reduction
NewAmsterdam Pharma Co N.V.
- Primary endpoint met: LS mean LDL-C reduction of 33% (p<0.0001) vs placebo at day 84 on top of maximally tolerated therapies.
- Observed 21% reduction in MACE (exploratory endpoint) at one year; hazard ratio 0.79 (95% CI 0.54-1.15).
- Obicetrapib well-tolerated: TEAEs 59.8% vs placebo 60.9%; discontinuation 11.1% vs 12.4%.
- NewAmsterdam plans to present additional BROADWAY data at upcoming medical meetings and discuss filings with regulators.