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 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
NewAmsterdam Pharma Provides Update on Obicetrapib Launch Timelines and Market Strategy
NAMS
Product Launch
New Projects/Investments
- NewAmsterdam Pharma's obicetrapib is on track for European approval in 2026, with its partner Menarini expected to launch the drug shortly thereafter, following the acceptance of the regulatory filing in 2025.
- The U.S. regulatory filing and commercial launch timelines for obicetrapib are dependent on the PREVAIL study results, which the company aims to leverage for broad payer access during the IRA period.
- The company anticipates obicetrapib will be more successful than Merck's oral PCSK9 in the cholesterol-lowering market, which is estimated to be $5 billion or higher, due to its distinct profile and additional benefits beyond LDL reduction.
- NewAmsterdam Pharma is exploring an Alzheimer's opportunity for obicetrapib, having observed intriguing signals in a sub-study, and plans to engage with the FDA for a Phase IIB trial.
Dec 2, 2025, 8:50 PM
NewAmsterdam Management Provides Update on Obicetrapib Regulatory Timelines and Commercial Strategy
NAMS
Product Launch
New Projects/Investments
Guidance Update
- NewAmsterdam Management (NAMS) anticipates European approval next year for its cholesterol-lowering drug, obicetrapib, with its partner Menarini launching shortly thereafter.
- The U.S. regulatory filing and launch for obicetrapib are dependent on the PREVAIL study outcome data, with the strategy focused on maximizing market opportunity and payer access.
- NAMS positions obicetrapib as a "class of one" CETP inhibitor, expecting to outperform Merck's oral PCSK9 due to its unique advantages beyond LDL reduction, such as potential benefits for Lp(a) and diabetes risk.
- The company highlights its commercial organization, led by Chief Commercial Officer B.J. Jones, which has a proven track record of successful drug launches.
- NAMS is also pursuing an Alzheimer's opportunity for obicetrapib, based on promising signals from a sub-study, and plans to engage with the FDA for a Phase IIB trial.
Dec 2, 2025, 8:50 PM
NewAmsterdam Pharma Provides Update on Obicetrapib Development and Market Strategy
NAMS
New Projects/Investments
Product Launch
- NewAmsterdam Pharma expects EMA approval in 2026 for obicetrapib, following three successful Phase 3 trials, with partner Menarini set to launch shortly thereafter.
- The company's intellectual property for obicetrapib in the U.S. has been extended to 2043 due to a new composition and matter patent granted last year.
- Confidence is high for a positive outcome from the PREVAIL CVOT trial, with the two-year mark anticipated in April 2026. The company plans to engage with the FDA in H1 2026 to discuss including CV outcomes data in the label.
- Obicetrapib's differentiated profile includes a 21% reduction in MACE from the Broadway trial, a decrease in new-onset diabetes, and a 45-50% reduction in Lp(a), offering advantages over other lipid-lowering therapies.
- The target patient population for lipid-lowering drugs has expanded to 60 million patients, indicating a large market opportunity.
Nov 19, 2025, 12:00 PM
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