NewAmsterdam Pharma Company NV（NAMS）資訊與事件NAMSNewAmsterdam Pharma Company NV

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 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."