{"id":937737,"date":"2026-02-18T07:08:39","date_gmt":"2026-02-18T12:08:39","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/newamsterdam-pharma-reports-full-year-2025-financial-results-and-provides-corporate-update\/"},"modified":"2026-02-18T07:08:39","modified_gmt":"2026-02-18T12:08:39","slug":"newamsterdam-pharma-reports-full-year-2025-financial-results-and-provides-corporate-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/newamsterdam-pharma-reports-full-year-2025-financial-results-and-provides-corporate-update\/","title":{"rendered":"NewAmsterdam Pharma Reports Full Year 2025 Financial Results and Provides Corporate Update"},"content":{"rendered":"
\n

\n — Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib\/ezetimibe fixed dose combination expected in 2H26 —<\/em>\n <\/p>\n

\n — Phase 3 PREVAIL CVOT blinded event rate tracking in line with observed event rate in BROADWAY–<\/em>\u00a0 \u00a0 \u00a0 \u00a0\u00a0<\/p>\n

\n — Topline data from RUBENS Phase 3 trial in patients with type 2 diabetes and metabolic syndrome expected by year-end 2026 — <\/em>\n <\/p>\n

\n — $728.9<\/em>
\n million in cash, cash equivalents and marketable securities at December 31, 2025 —<\/em>\n <\/p>\n

NAARDEN, the Netherlands and MIAMI, Feb. 18, 2026 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or \u201cNewAmsterdam\u201d or the \u201cCompany\u201d), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (\u201cCVD\u201d) with elevated low-density lipoprotein cholesterol (\u201cLDL-C\u201d), for whom existing therapies are not sufficiently effective or well-tolerated, today announced financial results for the full year ended December 31, 2025 and provided a corporate update.<\/p>\n

\u201c2025 marked a year of meaningful clinical and regulatory progress for NewAmsterdam, as we advanced our mission to bring a potentially transformative therapy with obicetrapib to cardiometabolic disease patients who continue to struggle to reach their LDL-C goals,\u201d said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. \u201cMarketing Authorization Applications for obicetrapib and the fixed dose combination were accepted for review by the European Medicines Agency (\u201cEMA\u201d), Switzerland, and United Kingdom regulators, and we anticipate a decision from each in the second half of 2026. In parallel, together with our partner Menarini, we are actively preparing for a potential commercial launch in Europe. In the United States, we continue to expand our commercial capabilities with the notable hiring of Steve Albers, former senior vice president of market access and public affairs at Novo Nordisk, who will now lead our market access and public affairs efforts, further strengthening our established team.\u201d<\/p>\n

\u201cAt the same time, we remain focused and well positioned to execute our clinical development strategy, including the advancement of obicetrapib in our three ongoing Phase 3 trials: PREVAIL, REMBRANT and RUBENS. In December 2025, we initiated the RUBENS trial, which will evaluate obicetrapib alone and in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome that require additional lowering of LDL-C despite treatment with available therapy, with topline data expected by year-end 2026. Our PREVAIL cardiovascular outcomes trial continues to progress well, where the overall blinded MACE event rate in PREVAIL through the initial 12-months was in line with what we observed in BROADWAY. NewAmsterdam continues to operate from a position of financial strength, with cash runway expected to be sufficient to fund operations through the PREVAIL readout and, if approved, support the subsequent U.S. commercial launch. Additionally, following positive biomarker results from the Alzheimer\u2019s disease analysis in the BROADWAY trial, we plan to initiate a new clinical trial evaluating obicetrapib in early Alzheimer\u2019s disease patients this year.\u201d<\/p>\n

\n Clinical Development and Regulatory Updates <\/strong>\n <\/p>\n

NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (\u201cCETP\u201d) inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated.<\/p>\n