other material
confidence high
sentiment positive
materiality 0.85
NewAmsterdam Pharma reports positive Phase 3 TANDEM topline data; FDC lowers LDL-C 48.6% vs placebo
NewAmsterdam Pharma Co N.V.
- Fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg achieved LS mean LDL-C reduction of 48.6% (p<0.0001) vs placebo at day 84.
- All co-primary endpoints met with statistical significance; FDC superior to both monotherapies (p<0.001).
- Over 60% of FDC patients saw >50% LDL-C reduction; ~71% achieved LDL-C <55 mg/dL.
- Safety well-tolerated; drug-related TEAEs 2.9% in FDC arm vs 3.9% placebo; no serious TEAEs.
- Data supports global regulatory filings for the FDC tablet.