ASCVD and/or HeFH patients
NAMSNewAmsterdam Pharma Company NVCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Obicetrapib + ezetimibe in ASCVD and/or HeFH patients. The expected timing is based on the latest available company guidance and may change.
TANDEM (Ph3) trials. 11/20/24- Ph3 topline (met endpoints). 5/7/25- New data at EAS. Additional data in 2025. 8/18/25- EMA MAA acceptance. 11/05/25:- EMA accepted MAAs for obicetrapib monotherapy and FDC; additional Phase 3 TANDEM data planned. 02/18/26:- Additional TANDEM FDC data planned in 2026; EMA/UK/Swiss approval decisions for obicetrapib/ezetimibe FDC expected H2 2026. 05/07/26:- Additional TANDEM FDC Phase 3 data planned during 2026; EMA/UK/Swiss decisions H2 2026; Menarini launches Germany/UK Q4 2026. 07/24/26:- CHMP recommended Evlarco EU marketing authorization. European Commission decision expected H2 2026. 08/05/26:- TANDEM FDC data and EC decision remain expected in 2026.
Verification
Confirm timing and program details against the company announcement or filing.