Earnings summaries and quarterly performance for NewAmsterdam Pharma Co.
Executive leadership at NewAmsterdam Pharma Co.
Michael Davidson
Detailed
Chief Executive Officer
CEO
BJ
BJ Jones
Detailed
Chief Commercial Officer
DK
Douglas Kling
Detailed
Chief Operating Officer
IS
Ian Somaiya
Detailed
Chief Financial Officer
JK
John Kastelein
Detailed
Chief Scientific Officer
JA
Juliette Audet
Detailed
Chief Strategy and Business Officer
LK
Louise Kooij
Detailed
Chief Accounting Officer
Board of directors at NewAmsterdam Pharma Co.
Research analysts covering NewAmsterdam Pharma Co.
Recent press releases and 8-K filings for NAMS.
NewAmsterdam Pharma Reports Full Year 2025 Financial Results and Provides Corporate Update
NAMS
Earnings
Guidance Update
New Projects/Investments
- NewAmsterdam Pharma Company N.V. reported a net loss of $203.8 million for the full year ended December 31, 2025, compared to a net loss of $241.6 million in the prior year, with revenue of $22.5 million.
- The company held $728.9 million in cash, cash equivalents, and marketable securities as of December 31, 2025.
- Approval decisions from EMA, UK, and Switzerland regulators for obicetrapib and its fixed-dose combination are expected in the second half of 2026.
- Topline data from the RUBENS Phase 3 trial is anticipated by year-end 2026, and a new clinical trial evaluating obicetrapib in early Alzheimer's disease patients is expected to be initiated in 2026.
- NewAmsterdam Pharma expects its cash runway to be sufficient to fund operations through the PREVAIL readout and, if approved, support the subsequent U.S. commercial launch.
Feb 18, 2026, 12:00 PM
NewAmsterdam Pharma Discusses Obicetrapib's Clinical Progress and Commercial Strategy
NAMS
Product Launch
New Projects/Investments
- NewAmsterdam Pharma's PREVAIL study for obicetrapib is showing an event rate at 12 months that is tracking in line with the BROADWAY study, which observed a 21% MACE benefit. An update on the overall study timelines is anticipated mid-year 2026, based on continued event adjudication out to at least two years.
- The company expects EMA approval in Europe in 2026 for obicetrapib and plans to provide US regulatory timelines mid-2026, with the US filing predicated on having outcomes data available at the time of launch.
- Obicetrapib is designed to help 70%-80% of patients reach their risk-based goal with a convenient 10-mg oral once-daily pill, offering benefits beyond LDL-C reduction, including Lp(a) reduction, virtual elimination of small particles, and a reduction in the incidence of diabetes.
- The PREVAIL study is designed for success by enrolling patients with high baseline LDL (over 100) and excluding those with heart failure, incorporating lessons from prior CETP inhibitor failures that focused on HDL.
Feb 11, 2026, 1:30 PM
NewAmsterdam Pharma Provides 2025 Achievements and 2026 Strategic Priorities Update
NAMS
Guidance Update
New Projects/Investments
Product Launch
- NewAmsterdam Pharma reported an unaudited cash, cash equivalents, and marketable securities balance of approximately $729 million as of December 31, 2025, which the company believes is sufficient to fund operations through the anticipated readout of its PREVAIL CVOT and support a subsequent US commercial launch, if approved.
- The company expects an EMA approval decision for obicetrapib and its fixed-dose combination in 2H 2026, following the acceptance of Marketing Authorization Applications in August 2025.
- NewAmsterdam Pharma initiated the Phase 3 RUBENS trial in December 2025, with topline results anticipated by the end of 2026, and plans to start a dedicated Alzheimer's trial in 2026.
Jan 9, 2026, 1:00 PM
NewAmsterdam Pharma Provides Updates on Obicetrapib Clinical Trials and Regulatory Filings
NAMS
Product Launch
New Projects/Investments
Guidance Update
- The PREVAIL CVOT study for obicetrapib is anticipated to read out in the back half of 2026, with an update expected around mid-2026. The study is powered to demonstrate benefit for both four-point and three-point MACE.
- NewAmsterdam Pharma is actively planning to file the NDA in the US in the first half of 2026, aiming to maximize the label at launch by including PREVAIL data, the Rubin study (diabetes), and Alzheimer's data.
- The EMA has accepted obicetrapib's filing for LDL-C-based monotherapy and fixed-dose combo with ezetimibe, with partner Menarini preparing for launch in Europe.
- Obicetrapib is highlighted for its multiple benefits beyond LDL-C lowering, including Lp(a) reduction, diabetes prevention, and potential Alzheimer's benefits, alongside a favorable safety profile.
- The HORIZON study is expected to read out in the first half of 2026, and the Tandem study (combo with PCSK9) is also on track to read out in 2026.
Dec 4, 2025, 1:00 PM
NewAmsterdam Pharma Provides Updates on PREVAIL CVOT, Regulatory Filings, and Obicetrapib's Differentiated Profile
NAMS
New Projects/Investments
Product Launch
Guidance Update
- NewAmsterdam Pharma's PREVAIL CVOT is anticipated to read out in the back half of 2026, with an update expected around mid-2026. A delay would likely be due to lower-than-expected event rates, which is considered a positive indicator.
- The European Medicines Agency (EMA) has accepted obicetrapib's filings for monotherapy and fixed-dose combination with ezetimibe, with partner Menarini preparing for launch in Europe.
- The company plans to file its US NDA for LDL in the first half of 2026, aiming to include PREVAIL, Rubin (diabetes), and Alzheimer's data in the label around launch to maximize impact.
- Obicetrapib is highlighted for its multiple benefits, including LDL-C and Lp(a) lowering, diabetes prevention, and potential Alzheimer's benefit, along with a strong safety profile.
Dec 4, 2025, 1:00 PM
NewAmsterdam Pharma Provides Updates on Clinical Trials and Regulatory Filings
NAMS
New Projects/Investments
Product Launch
Guidance Update
- NewAmsterdam Pharma expects the PREVAIL CVOT to read out in the back half of 2026, with an update on event rates anticipated around mid-2026.
- The EMA accepted obicetrapib's filing on August 18th for LDL-C-based monotherapy and fixed-dose combo, and the company plans to file its NDA in the U.S. in the first half of 2026.
- Obicetrapib is positioned for its ability to lower LDL-C and Lp(a), offer diabetes prevention, and provide an Alzheimer's benefit, alongside a favorable safety profile.
- Additional studies, including the TANDEM study (combo with PCSK9) and the Rubin study (diabetes), are on track to read out by the end of 2026, while the HORIZON trial is expected in the first half of 2026.
Dec 4, 2025, 1:00 PM
NewAmsterdam Pharma Provides Update on Clinical Trials and Market Potential
NAMS
New Projects/Investments
Guidance Update
- NewAmsterdam Pharma completed three Phase 3 trials, including BROADWAY, which demonstrated a 21% reduction in major adverse cardiac events (MACE), significant LDL and Lp(a) lowering, reduced diabetes risk, and an early signal for Alzheimer's prevention by reducing p-Tau217.
- The PREVAIL outcome study is progressing, with a minimum two-and-a-half-year follow-up expected around October 2026, and an update on timing for the medical and investor community anticipated in mid-2026.
- The company is planning a Phase 2B study for Alzheimer's prevention targeting APOE4 patients, starting next year (2026), which could potentially lead to accelerated approval.
- Management believes obicetrapib's peak sales potential is $8 billion+ based on cardiovascular benefits alone, significantly higher than the current consensus of $2-3 billion, and does not include any value for Alzheimer's benefits.
- NewAmsterdam Pharma has partnered with Menarini for European commercialization, leveraging their 6,000 sales representatives and strong cardiovascular market presence, with royalties up to mid-20% and over EUR 800 million in milestones.
Dec 3, 2025, 8:15 PM
NewAmsterdam Pharma Provides Update on Obicetrapib Trials and Market Outlook
NAMS
Product Launch
New Projects/Investments
Guidance Update
- NewAmsterdam Pharma completed its three Phase 3 BROADWAY trials in 2024, demonstrating a 21% reduction in Major Adverse Cardiac Events (MACE), with results intended for regulatory submission.
- Obicetrapib is differentiated by its ability to lower Lp(a) by approximately 50%, reduce diabetes risk, and show a benefit in Alzheimer's prevention through p-Tau217 biomarker reduction.
- The critical PREVAIL outcome study is on track, with a minimum two-and-a-half-year follow-up expected around October 2026, and an update on its timing anticipated in mid-2026.
- NewAmsterdam Pharma projects obicetrapib's peak sales potential to exceed $8 billion based on cardiovascular benefits alone, significantly higher than the current consensus of $2-3 billion.
- The company has partnered with Menarini for the European launch, benefiting from Menarini's 6,000 sales representatives and strong market presence, with potential royalties up to mid-20% and over EUR 800 million in outstanding milestones.
Dec 3, 2025, 8:15 PM
NewAmsterdam Pharma Discusses Obicetrapib's Broad Benefits and Clinical Progress
NAMS
New Projects/Investments
Product Launch
Guidance Update
- NewAmsterdam Pharma highlighted obicetrapib's broad benefits, including LDL lowering (40-50%), Lp(a) reduction (~50%), and potential for diabetes risk reduction and Alzheimer's prevention based on biomarker data.
- The PREVAIL outcome study is progressing well, with minimum 2.5-year follow-up expected around October 2026, and an update on timing anticipated in mid-2026.
- Management believes obicetrapib has a peak sales potential of $8 billion+ based solely on cardiovascular benefits, significantly higher than the current consensus of $2-3 billion.
- The company has partnered with Menarini for the European launch, leveraging their 6,000 sales representatives and strong cardiovascular market presence, with royalties up to mid-20% and over EUR 800 million in milestones.
- A new Phase 2B Alzheimer's study is planned to start in 2026, targeting high-risk APOE4 patients, with potential for accelerated approval.
Dec 3, 2025, 8:15 PM
NewAmsterdam Pharma Discusses Obicetrapib Regulatory Timelines and Commercial Strategy
NAMS
Product Launch
Guidance Update
New Projects/Investments
- NewAmsterdam Pharma's obicetrapib is on track for European approval in 2026, with partner Menarini launching shortly thereafter.
- The U.S. launch timeline for obicetrapib is dependent on the PREVAIL outcome study, which is essential for maximizing payer access and is anticipated in 2027.
- Obicetrapib demonstrated 35%-40% LDL reduction as monotherapy and 50%-55% in combination, offering additional benefits like a 15% reduction in new-onset diabetes and intriguing signals for Alzheimer's treatment.
- The company projects obicetrapib to be more successful than Merck's oral PCSK9 in the $5 billion+ market for new oral cholesterol-lowering drugs, supported by its unique profile and an experienced commercial team.
Dec 2, 2025, 8:50 PM
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