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NewAmsterdam Pharma Company (NAMS) investor relations material
NewAmsterdam Pharma Company Stifel Virtual Cardiometabolic Forum summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Stifel Virtual Cardiometabolic Forum summary30 Sep, 2025
Clinical trial progress and outcomes
All pivotal lipid-lowering registration studies (BROADWAY, BROOKLYN, TANDEM) are completed and published in leading journals.
PREVAIL, the major outcomes trial, is fully enrolled with baseline characteristics mirroring BROADWAY and event rates tracking as expected.
PREVAIL requires a minimum 2.5-year participation per patient, resulting in a longer median follow-up than recent trials.
PREVAIL is four times larger and longer than BROADWAY, aiming to confirm the 21% MACE reduction seen previously.
Additional studies, including REMBRANDT (CT angio trial with Harvard) and an Alzheimer’s biomarker sub-study, are ongoing.
Regulatory and commercial strategy
European filings for both monotherapy and fixed-dose combination have been accepted, with potential approvals expected in the second half of next year.
U.S. launch is planned to coincide with PREVAIL outcomes data; final readout timing will be clearer next year as event rates are monitored.
Discussions with the FDA regarding data readout and approval process are scheduled for next year.
Scientific insights and data interpretation
BROADWAY showed a 21% reduction in MACE, supported by Kaplan-Meier curves and mediation analysis linking LDL, LDL particles, and Lp(a) to outcomes.
LDL particles, especially small ones, are considered better predictors of cardiovascular risk than LDL-C alone, with CETP inhibition dramatically reducing these particles.
Ongoing analyses in large databases and clinical trials aim to further validate the predictive value of LDL particles and ApoB.
US filing strategy with PREVAIL data
Evidence for 21% MACE reduction in BROADWAY?
Obicetrapib's unique differentiators?
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Next NewAmsterdam Pharma Company earnings date
Q3 20256 Nov, 2025
Next NewAmsterdam Pharma Company earnings date
Q3 20256 Nov, 2025
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Frequently asked questions
NewAmsterdam Pharma Company N.V. is a clinical-stage biopharmaceutical company based in the Netherlands, focusing on the development of oral and non-statin medicines for patients at high risk of cardiovascular disease. Its leading product candidate is obicetrapib, a next-generation, oral, and low-dose cholesteryl ester transfer protein (CETP) inhibitor, currently in various stages of clinical trials. The company's mission is aimed at improving patient care in populations with metabolic diseases where currently approved therapies have not been sufficiently successful or well tolerated, with a significant focus on creating a potent, cost-effective, and convenient LDL-lowering therapy. The company is headquartered in Naarden, the Netherlands, and its shares are listed on the Nasdaq.
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