Machine learning predictions based on historical earnings data and price patterns
1-Day Prediction
+3.68%
$28.43
100% positive prob.
5-Day Prediction
+8.81%
$29.84
100% positive prob.
20-Day Prediction
+4.30%
$28.60
95% positive prob.
SEC 8-K filings with transcript text
Aug 5, 2026 · 100% conf.
1D
+3.68%
$28.43
Act: +0.91%
5D
+8.81%
$29.84
Act: +1.50%
20D
+4.30%
$28.60
2 nams-ex99_1.htm
NewAmsterdam Pharma Provides Corporate Update and Reports Second Quarter Financial Results
– Announced positive CHMP opinion recommending marketing authorization for obicetrapib and obicetrapib/ezetimibe –
– PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027 –
– Topline data from RUBENS Phase 3 expected by year-end 2026 –
– $678.3 million in cash, cash equivalents and marketable securities at June 30, 2026 –
– Company to host investor day today at 9:00 AM ET in New York City –
Naarden, the Netherlands and Miami, USA; August 5, 2026 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” 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 financial results for the quarter ended June 30, 2026 and provided a corporate update.
“During the second quarter, we continued to build momentum across our regulatory, clinical, and scientific priorities,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “Our quarterly update is headlined by the positive opinion for Europe from CHMP, recommending the granting of a marketing authorization for Ubeslo and Evlarco, intended for the treatment of primary hypercholesterolemia or mixed dyslipidemia. Additionally, supportive analyses presented at NLA and AAIC continue to expand the growing body of evidence supporting the potential of obicetrapib across multiple diseases. As we continue to advance our late-stage development program and prepare for several important regulatory and clinical milestones in the months ahead, we remain focused on disciplined execution and look forward to sharing additional updates on our strategy, pipeline, and priorities during today’s Investor Day.”
Clinical Development Updates
NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated.
In July 2026, NewAmsterdam announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (“EMA”) has adopted a positive opinion recommending marketing authorization for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (“FDC”) for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. A final decision from the European Commission is expected later this year.
In July 2026, NewAmsterdam presented four analyses from its Phase 3 BROADWAY program at the Alzheimer's Association International Conference (AAIC) 2026, further characterizing the potential role of CETP inhibition in the prevention of early Alzheimer’s disease. Highlights include:
• Prespecified analyses from the Phase 3 BROADWAY trial demonstrated statistically significant reductions in plasma p-tau217 versus placebo.
• Additional analyses provided further insights into Alzheimer’s disease biology and potential approaches to optimize future clinical development.
In June 2026, NewAmsterdam presented four analyses at the National Lipid Association (“NLA”) Scientific Sessions further characterizing obicetrapib’s differentiated profile across atherosclerotic cardiovascular disease (“ASCVD”) and heterozygous familial hypercholesterolemia (“HeFH”). The analyses included pooled Phase 3 BROADWAY and BROOKLYN data, real-world evidence from a large U.S. claims database and a cross-class review of contemporary cholesterol-lowering development programs. Highlights included:
• Two real-world analyses using the Komodo Claims and Research Dataset highlighted persistent gaps in LDL-C goal attainment, treatment adherence, and tolerability among high-risk patients receiving high-intensity statins, reinforcing the need for additional well-tolerated LDL-C lowering therapies.
• A pooled mediation analysis of the Phase 3 BROADWAY and BROOKLYN trials found that obicetrapib was observed to reduce major adverse cardiovascular events (“MACE”) by 23%, with reductions in LDL-C and lipoprotein(a) jointly mediating 84.5% of this observed benefits. This analysis further found that the observed MACE benefit was primarily attributable to LDL-C lowering, with Lp(a) as an important additional mediator.
• A cross-class review of contemporary cholesterol-lowering development programs suggest suggested non-CVOT MACE assessments may provide meaningful insight into subsequent cardiovascular outcomes.
NewAmsterdam plans to present additional analyses from the BROOKLYN and BROAD
May 7, 2026
2 nams-ex99_1.htm
NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results
– Decisions on regulatory approval from EMA, UK, and Switzerland for obicetrapib and obicetrapib/ezetimibe fixed‑dose combination expected in 2H26, and based on the outcomes, with potential launches by Menarini in 4Q26 in Germany and the UK –
– PREVAIL interim analysis planned for 4Q2026 with result expected in 1Q2027 –
– Completed enrollment in REMBRANDT; Topline data from RUBENS Phase 3 expected by year-end 2026 –
– Presented new analyses of Phase 3 BROOKLYN and BROADWAY studies at the American College of Cardiology Annual Scientific Session (ACC) and simultaneously published in the American Journal of Preventative Cardiology–
– $707.3 million in cash, cash equivalents and marketable securities at March 31, 2026 –
– Management to host PREVAIL update call today at 8:00 AM ET –
Naarden, the Netherlands and Miami, USA; May 7, 2026 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” 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 financial results for the quarter ended March 31, 2026 and provided a corporate update.
“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, M.D., 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.”
Clinical Development Updates
NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated.
In March 2026, NewAmsterdam presented results from additional analyses of its pivotal Phase 3 BROADWAY and BROOKLYN trials evaluating obicetrapib in patients with established atherosclerotic cardiovascular disease (“ASCVD”) and/or heterozygous familial hypercholesterolemia (“HeFH”) at ACC, which were simultaneously published in the American Journal of Preventative Cardiology. The new analyses explored the potential effects of obicetrapib beyond LDL-C lowering, including signals related to new-onset diabetes mellitus and kidney function, and further evaluated the investigational therapy’s safety profile. Data presented include:
• Pooled analysis of the BROADWAY and BROOKLYN trials showed that CETP inhibition with obicetrapib 10 mg was associated with a slower annualized decline in estimated glomerular filtration rate (eGFR) (-0.41 vs. -1.08 with placebo; difference of 0.67 mL/min/1.73 m²) in patients with high cardiovascular risk.
• Patients treated with obicetrapib had nominally fewer composite renal events over 12 months, consisting of death due to cardiovascular or renal causes, eGFR <15 mL/min/1.73 m² post- baseline, ≥40 % decline in eGFR from baseline, kidney transplant, or dialysis initiation. The analysis of time weighted achieved HDL-C versus
renal event indicated a strong association between higher achieved HDL-C and lower renal event risk (spline nominal P < 0.0001), independent of baseline HDL-C and eGFR.
• Pooled Phase 3 safety analysis from BROOKLYN and BROADWAY continued to reinforce the safety and tolerability profile of obicetrapib.
• Findings that higher small/medium LDL particle (“LDL-P”) discordance was observed to be independently associated with incident major adverse cardiovascular events (“MACE”), specifically in patients with high cardiometabolic burden.
Datasets from the analyses were published in the American Journal of Preventive Cardiology. The full posters presented at ACC are available on the Scientific Publications and Presentations page of the NewAmsterdam Pharma website at www.newamsterdampharma.com/publications/.
NewAmsterdam plans to present additional an
Feb 18, 2026
2 nams-ex99_1.htm
NewAmsterdam Pharma Reports Full Year 2025 Financial Results and Provides Corporate Update
-- Approval decisions from EMA, UK and Switzerland regulators for obicetrapib and obicetrapib/ezetimibe fixed dose combination expected in 2H26 --
-- Phase 3 PREVAIL CVOT blinded event rate during the initial 12-months tracking in line with observed event rate in BROADWAY--
-- Topline data from RUBENS Phase 3 trial in patients with type 2 diabetes and metabolic syndrome expected by year-end 2026 --
-- $728.9 million in cash, cash equivalents and marketable securities at December 31, 2025 --
Naarden, the Netherlands and Miami, USA; February 18, 2026 – NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” 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 financial results for the full year ended December 31, 2025 and provided a corporate update.
“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, M.D., Chief Executive Officer of NewAmsterdam. “Marketing Authorization Applications for obicetrapib and the fixed dose combination were accepted for review by the European Medicines Agency (“EMA”), 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 several notable hires that will lead our market access and public affairs efforts, expanding the already 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.”
Clinical Development and Regulatory Updates
NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily, highly-selective cholesteryl ester transfer protein (“CETP”) inhibitor, as a monotherapy and in fixed-dose combination with ezetimibe, as the preferred LDL-C lowering therapy to be used in patients at risk of CVD for whom existing therapies are not sufficiently effective or well-tolerated.
• 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, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. Subsequently, MAAs were also submitted to regulators in UK and Switzerland and accepted for review. The MAAs were submitted by NewAmsterdam’s partner, A. Menarini International Licensing S.A. (“Menarini”), who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive License Agreement (the “Menarini License”). NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the European countries covered by the Menarini License and
up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones.
• In August 2025, NewAmsterdam presented pooled data from its pivotal Phase 3 BROADWAY and BROOKLYN trials on the impact of obicetrapib on major adverse cardiovascular events at the European Society of Cardiology Congress (“ESC”) 2025, along with the simultaneous pu
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