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NAMS-News
NAMS-Events
NewAmsterdam Pharma and Menarini Receive Positive Opinion for Ubeslo and Evlarco
NewAmsterdam Pharma along with partner Menarini Group announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Ubeslo and Evlarco for patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidemia. "Today's positive CHMP opinion is a significant milestone - not just for NewAmsterdam but for a novel therapy, addressing LDL-C and other drivers of residual cardiovascular risk," said Michael Davidson, CEO of NewAmsterdam.
NewAmsterdam Pharma to Conduct Interim Analysis in Q4 2026
"Our clinical execution remains strong. We have completed enrollment in REMBRANDT and continue to advance PREVAIL and RUBENS - three Phase 3 trials that underscore the breadth and maturity of our development program," said Michael Davidson, Chief Executive Officer of NewAmsterdam Pharma. "We are excited following an initial blinded review of PREVAIL data after the two-year anniversary of enrollment completion - which showed a Year 1 overall MACE event rate consistent with BROADWAY and a Year 1-to-Year 2 overall MACE event rate lower than expected - and we have decided to conduct an interim analysis in the fourth quarter of 2026. This timing coincides with the minimum 2.5-year follow-up for the trial. We are optimistic about the interim analysis and expect to report the result of the analysis in the first quarter of 2027. Should the trial not stop for efficacy at that time, we anticipate completion by the end of 2027. We will provide further details at our annual Investor Day on August 5, 2026."
NewAmsterdam Plans to Release Obicetrapib Trial Data in 2026
Following the completion and 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.
NewAmsterdam Reports Net Loss of $203.8 Million for 2025
Net loss for the year ended December 31, 2025, was $203.8 million, compared to net loss of $241.6 million in the year ended December 31, 2024. "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, CEO. "Marketing Authorization Applications for obicetrapib and the fixed dose combination were accepted for review by the European Medicines Agency, 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."
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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