Business
NewAmsterdam Pharma Highlights 2025 Achievements and Outlines 2026 Strategic Priorities
-- EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26 -- -- Phase 3 PREVAIL CVOT overall event rate tracking in
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"-- EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26 -- -- Phase 3 PREVAIL CVOT overall event rate tracking in line with observed rate in BROADWAY -- -- First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome -- -- Year-end cash, cash equivalents and marketable securities balance of approximately $729 million (unaudited) -- NAARDEN, the Netherlands and MIAMI, Jan. 09, 2026 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2026. NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, and highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. \"2025 was an important year for NewAmsterdam, as we continued to further the regulatory process for obicetrapib and the fixed-dose combo. In partnership with Menarini, the company is preparing for a potential commercial launch in Europe, contingent upon an EMA approval decision that is expected in 2H26. In PREVAIL, we are encouraged by the rate of overall MACE events (blinded) in this cardiovascular outcomes trial (“CVOT”), which suggest that the initial 12 month rate is tracking in line with the overall rate observed in the Phase 3 BROADWAY trial,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are also excited to announce the RUBENS trial enrolled its first few patients in December and could allow for additional label enhancements, if approved, for patients with Type 2 Diabetes and/or Metabolic Syndrome that are not at their LDL-C risk-based goals. We expect topline results from ...