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NewAmsterdam Pharma Announces Late-Breaking Data from BROADWAY and TANDEM Pivotal Studies Published in Leading Medical Journals and Presented at the European Atherosclerosis Society (EAS) Congress 2025
– Late Breaking BROADWAY and TANDEM data presented at EAS 2025 and simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":"– Late Breaking BROADWAY and TANDEM data presented at EAS 2025 and simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM) – – Phase 3 data showed that obicetrapib as an adjunct to statins, whether in combination with ezetimibe or as monotherapy, reduced LDL-C by 50% and 35%, respectively; in addition, Phase 2 data of obicetrapib in combination with moderate-dose statins showed LDL-C reductions of approximately 70% – – 21% observed reduction in major adverse cardiovascular events (HR=0.79, CI 0.54-1.15) in BROADWAY trial – – Pooled Phase 3 data showed Lp(a) reductions of 45% across BROADWAY, TANDEM, and BROOKLYN trials for patients with increased risk levels of Lp(a) from 50-150 nmol/L at baseline – NAARDEN, The Netherlands and MIAMI, May 07, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam,” “we,” 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 additional data from the BROADWAY and TANDEM pivotal Phase 3 studies were presented as late-breaking oral presentations at the European Atherosclerosis Society Congress (“EAS”) 2025 and simultaneously published in The New England Journal of Medicine (BROADWAY) and The Lancet (TANDEM). “We are proud to share what we believe to be compelling clinical data from two comprehensive clinical trials conducted in the CVD space, now published in leading peer-reviewed journals and as late-breaking presentations at EAS 2025,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “We believe the additional data presented today further supports obicetrapib as a meaningful advancement in the development of an oral medication to be used adjunctively to statins. These results will support global regulatory filings and reinforce our belief that obicetrapib has the potential to be an effective, once-daily, oral treatment that significantly reduces LDL-C.” Key previously-reported findings from the BROADWAY clinical trial evaluating obicetrapib in patients with atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hyp...