-- Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination expected in 2H26 --

-- Phase 3 PREVAIL CVOT blinded event rate tracking in line with observed event rate in BROADWAY--

-- Topline data from RUBENS Phase 3 trial in patients with type 2 diabetes and metabolic syndrome expected by year-end 2026 --

-- $728.9 million in cash, cash equivalents and marketable securities at December 31, 2025 --

NAARDEN, the Netherlands and MIAMI, Feb. 18, 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 announced financial results for the full year ended December 31, 2025 and provided a corporate update.

"2025 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," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. "Marketing Authorization Applications for obicetrapib and the fixed dose combination were accepted for review by the European Medicines Agency ("EMA"), 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."

"At 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's disease analysis in the BROADWAY trial, we plan to initiate a new clinical trial evaluating obicetrapib in early Alzheimer's disease patients this year."

Clinical Development and Regulatory Updates

NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein ("CETP") 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.

   -- In August 2025, NewAmsterdam announced acceptance of MAAs for review by 
      the EMA for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 
      mg ezetimibe FDC for patients with primary hypercholesterolemia, both 
      heterozygous familial ("HeFH") and non-familial or mixed dyslipidemia. 
      Subsequently, MAAs were also submitted to regulators in UK and 
      Switzerland and accepted for review. The MAAs were submitted by 
      NewAmsterdam's partner, A. Menarini International Licensing S.A. 
      ("Menarini"), who is responsible for communications with regulatory 
      authorities in Europe and for the commercialization and local development 
      of obicetrapib in Europe and other collaborative activities pursuant to 
      an exclusive License Agreement (the "Menarini License"). NewAmsterdam is 
      entitled to tiered double-digit percentage royalties ranging from the low 
      double-digits to mid-twenties on net sales in the European countries 
      covered by the Menarini License and up to an additional EUR833 million 
      upon the achievement of various clinical, regulatory and commercial 
      milestones. 
 
   -- In August 2025, NewAmsterdam presented pooled data from its pivotal Phase 
      3 BROADWAY and BROOKLYN trials on the impact of obicetrapib on major 
      adverse cardiovascular events at the European Society of Cardiology 
      Congress ("ESC") 2025, along with the simultaneous publication in the 
      Journal of the American College of Cardiology, highlighting obicetrapib's 
      performance across diverse lipid-lowering backgrounds observed in these 
      trials. The presentation and publication underscore the Company's 
      continued momentum in advancing obicetrapib as a differentiated oral 
      therapy for patients with elevated LDL-C. 
 
   -- In June and July 2025, NewAmsterdam announced positive data from the 
      prespecified AD biomarker analysis in the BROADWAY clinical trial and 
      presented at the 2025 Alzheimer's Association International Conference 
      ("AAIC"). The pre-specified analysis was conducted to assess the effect 
      of obicetrapib on plasma biomarkers of AD in both the full analysis set 
      and in patients carrying the apolipoprotein E4 ("ApoE4") gene, based on 
      phenotypic analysis. 
 
          -- NewAmsterdam observed statistically significant reductions in 
             p-tau217, a key biomarker of AD pathology, in both the full 
             analysis set (p<0.002, n=1,515) and in ApoE4 carriers (p=0.0215, 
             n=367), which NewAmsterdam believes support an emerging link 
             between CETP-inhibition and neurodegeneration. 
 
          -- In ApoE4/E4 carriers, the highest risk category for Alzheimer's 
             disease, obicetrapib was observed to reduce p-tau217 levels by 
             20.5%, over 12 months, compared to placebo (p=0.010, n=29). 
 
          -- In October 2025, the data was published in the Journal of 
             Prevention of Alzheimer's Disease. 

Upcoming Milestones and Ongoing Trials:

Following the successful completion and positive topline results of the Phase 3 BROADWAY, TANDEM, and BROOKLYN trials, NewAmsterdam plans to announce additional data from these trials relating to obicetrapib and the FDC of obicetrapib plus ezetimibe during 2026.

The following Phase 3 trials are currently ongoing:

   -- PREVAIL Phase 3 trial: PREVAIL is a CVOT evaluating obicetrapib in 
      patients with a history of ASCVD, whose LDL-C is not adequately 
      controlled despite being on maximally tolerated lipid-lowering therapy. 
      NewAmsterdam completed enrollment of over 9,500 patients in April 2024. 
 
   -- REMBRANDT Phase 3 trial: The REMBRANDT trial utilizes coronary computed 
      tomography angiography imaging to evaluate the effect of obicetrapib plus 
      ezetimibe FDC on coronary plaque burden. The placebo-controlled, 
      double-blind, randomized, Phase 3 trial is being conducted in adult 
      participants with high-risk ASCVD with evidence of coronary plaque who 
      are not adequately controlled by their maximally tolerated 
      lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg 
      plus ezetimibe 10 mg FDC daily on coronary plaque and inflammation 
      characteristics. The trial is expected to complete enrollment of 
      approximately 300 patients in 2026. 
 
   -- RUBENS Phase 3 trial: Initiated in December 2025, the RUBENS trial will 
      evaluate obicetrapib alone or 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. The trial is 
      expected to enroll approximately 300 patients, with topline data expected 
      by year end 2026. 

Additionally, NewAmsterdam expects to initiate a new clinical trial evaluating obicetrapib in early Alzheimer's disease patients in 2026.

Full Year 2025 Financial Results

   -- Cash Position: As of December 31, 2025, NewAmsterdam reported cash, cash 
      equivalents and marketable securities of $728.9 million, compared to 
      $834.2 million as of December 31, 2024. The decrease was primarily driven 
      by cash outflows related to research and development costs as the Company 
      continues development of obicetrapib and spending on selling, general and 
      administrative expenses to support the Company's ongoing operations, 
      partially offset by cash inflows from the exercise of options and 
      warrants. 
 
   -- Revenue: NewAmsterdam recognized $22.5 million in revenue for the year 
      ended December 31, 2025, compared to $45.6 million in the year ended 
      December 31, 2024. The decrease in revenue related to clinical 
      development milestones pursuant to the Menarini License was partially 
      offset by an increase in the amount of revenue recognized in the current 
      period related to the development cost contributions under the Menarini 
      License. 
 
   -- Research and Development ("R&D") Expenses: R&D expenses were $141.8 
      million for the year ended December 31, 2025, compared to $151.4 million 
      in the year ended December 31, 2024. The decrease was primarily driven by 
      a decrease in clinical expenses mainly due to the completion of several 
      Phase 3 clinical trials in the second half of 2024 and cost phasing in 

(MORE TO FOLLOW) Dow Jones Newswires

February 18, 2026 07:00 ET (12:00 GMT)