NewAmsterdam Pharma Updates Obicetrapib Clinical Development Program
NewAmsterdam Pharma provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2026. Key 2025 Achievements: 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; In August 2025, NewAmsterdam presented pooled efficacy and safety data from its pivotal Phase 3 BROADWAY and BROOKLYN trials at the European Society of Cardiology Congress 2025; 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. Key Expected 2026 Milestones and Ongoing Trials: 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. REMBRANDT Phase 3 trial: The trial utilizes coronary computed tomography angiography imaging to evaluate the effect of obicetrapib plus ezetimibe FDC on coronary plaque. 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
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NewAmsterdam Pharma Expects EMA Approval for Obicetrapib in 2H26
- Clinical Trial Progress: NewAmsterdam Pharma has enrolled its first patient in the RUBENS Phase 3 trial initiated in December 2025, which is expected to provide new treatment options for patients with metabolic syndrome, thereby enhancing the company's competitive position in the cardiovascular disease market.
- Strong Financial Position: As of December 31, 2025, NewAmsterdam reported a cash, cash equivalents, and marketable securities balance of approximately $729 million, which is sufficient to fund operations through the anticipated readout of the PREVAIL trial, ensuring future commercialization potential.
- Regulatory Advancements: The company is advancing its EMA applications for obicetrapib and its fixed-dose combination with Menarini, with an expected approval decision in 2H26, which will lay the groundwork for commercialization in the European market.
- Clear Strategic Goals: NewAmsterdam plans to initiate a clinical trial for Alzheimer's disease in 2026, further expanding the indications for obicetrapib, demonstrating the company's strategic positioning in both cardiovascular and neurodegenerative disease sectors.






