NewAmsterdam cash runway supports path to key 2026 regulatory decisions
$729M war chest funds operations through obicetrapib cardiovascular outcomes trial readout as EMA approval expected second half of 2026
NewAmsterdam Pharma reported full-year 2025 financial results showing a narrowing loss and substantial cash reserves, positioning the biotechnology company to reach critical regulatory and clinical milestones in the second half of 2026. The company's cholesterol-lowering drug obicetrapib is under review by European regulators, with approval decisions expected alongside topline results from a landmark cardiovascular outcomes trial.
The Dutch biotechnology company posted revenue of $22.5 million for the year ended December 31, 2025, down from $45.6 million in the prior year. The decline was primarily attributed to reduced clinical development milestones under the Menarini License agreement, partially offset by increased revenue from development cost contributions. Net loss improved to $203.8 million from $241.6 million in 2024.
More importantly, NewAmsterdam reported cash, cash equivalents, and marketable securities of $728.9 million as of December 31, 2025. This represents a decrease from $834.2 million at year-end 2024, but the company stated the remaining runway funds operations through the PREVAIL cardiovascular outcomes trial readout, expected in late 2026.
"Approval decisions from the European Medicines Agency, UK, and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination are expected in the second half of 2026," the company said in its earnings announcement. Marketing Authorization Applications for both the monotherapy and fixed-dose combination were accepted for review by European regulators in August 2025.
The PREVAIL Phase 3 trial, which enrolled more than 9,500 patients with a history of cardiovascular disease whose LDL cholesterol remains inadequately controlled, is a pivotal study for obicetrapib. The blinded major adverse cardiovascular events rate through the initial 12 months is tracking in line with observations from the BROADWAY trial. That earlier trial demonstrated positive LDL cholesterol lowering efficacy and an exploratory 21% reduction in cardiovascular events after one year.
Analysts maintain an overwhelmingly positive outlook on NewAmsterdam shares. Thirteen analysts rate the stock a "Buy" or "Strong Buy", with just one "Hold" rating. The consensus price target stands at $48.85, representing substantial upside from current levels around $34-35.
Leerink Partners raised its price target to $55 from $45 in January, maintaining an "Outperform" rating and naming NewAmsterdam one of its "Top Picks for 2026." The firm cited obicetrapib's potential as a differentiated cardiovascular platform. H.C. Wainwright reiterated a "Buy" rating with a $52 target, while RBC Capital increased its target to $47 from $44, maintaining an "Outperform" rating.
Beyond cardiovascular applications, NewAmsterdam is expanding obicetrapib's potential into neurodegenerative disease. Following positive biomarker results from the Alzheimer's disease analysis in the BROADWAY trial, the company plans to initiate a clinical trial evaluating obicetrapib in early Alzheimer's patients in 2026. The BROADWAY analysis showed statistically significant reductions in p-tau217, a key biomarker of Alzheimer's pathology.
The RUBENS Phase 3 trial, initiated in December 2025, will evaluate obicetrapib alone or in combination with ezetimibe in patients with type 2 diabetes or metabolic syndrome requiring additional LDL cholesterol lowering. Topline data from that approximately 300-patient study is expected by year-end 2026.
Pooled data from the BROADWAY and BROOKLYN pivotal Phase 3 trials on obicetrapib's impact on major adverse cardiovascular events were presented at the European Society of Cardiology Congress 2025 and published in the Journal of the American College of Cardiology in August 2025.
With nearly $730 million in cash and a clear path to multiple value-creating catalysts, NewAmsterdam appears well-funded to execute on its ambitious clinical and regulatory agenda. The convergence of European regulatory decisions and cardiovascular outcomes data in the second half of 2026 could determine whether obicetrapib achieves the blockbuster potential analysts envision.