NewAmsterdam Pharma closed 2025 with $728.9 million in cash, cash equivalents and marketable securities, securing funding through the PREVAIL cardiovascular outcomes trial readout. Management expects this cash runway to support ongoing operations, the potential U.S. commercial launch of obicetrapib and initial Alzheimer’s disease trial costs.

Marketing Authorization Applications for obicetrapib 10 mg monotherapy and the 10 mg obicetrapib/10 mg ezetimibe fixed-dose combination have been accepted for review by EMA, UK and Swiss authorities. Final decisions are anticipated in the second half of 2026, triggering potential European launch preparations and up to €833 million in milestone payments from Menarini, plus tiered double-digit royalties.

The PREVAIL CVOT is tracking MACE event rates in line with the BROADWAY trial, reinforcing confidence in trial design and timelines. The RUBENS Phase 3 study in type 2 diabetes and metabolic syndrome patients was initiated in December 2025, with topline data expected by year-end 2026, and an early Alzheimer’s disease trial is planned following positive biomarker reductions in p-tau217.

In parallel with regulatory reviews, NewAmsterdam and partner Menarini are preparing for a potential European launch of obicetrapib and its FDC product. In the U.S., the company strengthened its market access team by hiring Steve Albers, former SVP of market access and public affairs at Novo Nordisk, to lead payer and public affairs strategies.