NewAmsterdam Pharma Company N.V. (NAMSW) Bundle
NewAmsterdam Pharma Company N.V., a late-stage clinical biopharmaceutical company founded in 2019 by Forbion and Professor Dr. John Kastelein, is singularly focused on addressing unmet needs in lipid management through advancement of obicetrapib, an oral, low-dose, once-daily CETP inhibitor designed to provide a safe, well-tolerated LDL-C lowering option for patients at risk of cardiovascular disease; with a June 2022 exclusive licensing agreement with the Menarini Group for European commercialization while retaining global rights, NAMSW aligns a mission to improve care for metabolic disease populations where current therapies fall short with a vision to establish obicetrapib as a premier LDL-C therapy that could meaningfully impact the outcomes of millions of patients worldwide, and underpins this work with core values of excellence, integrity, inclusivity, open communication, ownership, and bold innovation.
NewAmsterdam Pharma Company N.V. (NAMSW) - Intro
Overview- NewAmsterdam Pharma Company N.V. (NAMSW) is a late-stage clinical biopharmaceutical company focused on innovative therapies for cardiovascular disease (CVD) and lipid disorders.
- Lead program: obicetrapib, an oral, low‑dose, once‑daily cholesteryl ester transfer protein (CETP) inhibitor designed to deliver meaningful LDL‑C lowering in patients at elevated CVD risk.
- Founded in 2019 by Forbion and lipidologist Prof. Dr. John Kastelein; public ticker NAMS (NASDAQ).
- June 2022: entered an exclusive licensing agreement with the Menarini Group for commercialization in Europe while retaining global commercialization rights.
- Leadership combines physicians and industry experts across clinical development, regulatory affairs, medical affairs, business development, and commercial strategy.
- Develop and deliver accessible, safe, and effective lipid‑lowering therapies that reduce cardiovascular events and improve patient quality of life.
- Advance scientific innovation in lipidology and translate rigorous clinical evidence into broad patient benefit.
- Be a global leader in next‑generation lipid management by providing oral, scalable therapeutic options that complement existing standards of care.
- Create durable value for patients, clinicians, and shareholders through disciplined clinical development, strategic partnerships, and responsible commercialization.
- Science‑driven decision making: prioritize robust data, reproducibility, and transparent trial design.
- Patient centricity: design trials and programs that address unmet needs and real‑world adherence challenges.
- Integrity and compliance: maintain high regulatory, ethical, and corporate governance standards.
- Collaborative partnerships: combine internal expertise with external partners (e.g., Menarini) to accelerate access.
- Long‑term sustainability: balance commercial ambition with healthcare affordability and access.
- Obicetrapib: oral CETP inhibitor, once daily, developed to provide incremental LDL‑C lowering when used alone or on top of statin therapy.
- Clinical signal: phase 2 programs reported robust LDL‑C reductions versus baseline and placebo, with maximal cohort reductions reported up to ~50% in select dosing cohorts.
- Regulatory pathway: positioned as a late‑stage development candidate with plans for pivotal development and regulatory submissions in major markets.
| Item | Detail |
|---|---|
| Company founded | 2019 |
| Founder(s) | Forbion; Prof. Dr. John Kastelein |
| Lead asset | Obicetrapib (oral CETP inhibitor) |
| Clinical status | Late‑stage development (pivotal planning following positive phase 2 data) |
| Reported LDL‑C reduction (phase 2, max cohort) | Up to ~50% vs baseline in selected dosing cohorts |
| Commercial partnership (Europe) | Exclusive license with Menarini Group (June 2022) |
| Stock listing | NASDAQ: NAMS |
- Value proposition: an oral, low‑dose CETP inhibitor that can be prescribed broadly and combined with existing lipid‑lowering therapies to help patients reach LDL‑C goals.
- Partner strategy: outsources regional commercialization (e.g., Menarini in Europe) while preserving global upside and retaining strategic control over broader markets.
- Market opportunity: targeting large populations with residual LDL‑C risk despite statin therapy; global dyslipidemia patient pool measured in tens of millions across guideline‑defined risk categories.
- Capital strategy: public markets (NASDAQ listing) and partnership structures used to fund pivotal development and support regulatory submissions.
- R&D focus: allocate resources to pivotal trials, safety monitoring, and scalable manufacturing for an oral small molecule product.
- Clinical credibility: leadership includes internationally recognized lipidologists and clinical experts to guide trial design and safety oversight.
- Commercial readiness: commercial and regulatory veterans prepare launch planning, payer strategy, and health‑economics evidence generation.
NewAmsterdam Pharma Company N.V. (NAMSW) - Overview
NewAmsterdam Pharma Company N.V. (NAMSW) centers its strategy and R&D around a clear, patient-focused mission: to improve care for populations with metabolic diseases where currently approved therapies have been inadequate or poorly tolerated. The company's lead candidate, obicetrapib, is being advanced specifically to meet a substantial unmet need for a safe, well‑tolerated, and convenient LDL‑C lowering therapy for patients at elevated cardiovascular risk.- Primary mission: Deliver an effective LDL‑C lowering option for patients with elevated LDL‑C who cannot achieve target levels with existing therapies or who experience intolerance to current treatments.
- Therapeutic focus: Metabolic diseases, with particular emphasis on atherosclerotic cardiovascular disease (ASCVD) risk reduction via LDL‑C lowering.
- Patient-centric goals: Prioritize tolerability, convenience (oral dosing), and broad accessibility.
- Consistency: Mission has remained stable over time, reinforcing long‑term commitment to improving lipid management and patient outcomes.
| Program / Metric | Result / Status |
|---|---|
| Lead candidate | Obicetrapib (oral CETP inhibitor) |
| Phase | Phase 3 program ongoing (pivotal trials evaluating LDL‑C lowering vs background therapy) |
| Observed LDL‑C reduction (clinical data summary) | Up to ~50% mean reductions in LDL‑C vs baseline in key dose groups in controlled studies (additive to statins in many cohorts) |
| Tolerability profile | Generally well tolerated in trials, with adverse event rates comparable to placebo in most analyses |
| Administration | Oral once‑daily dosing (designed for convenience vs injectable alternatives) |
- Global LDL‑lowering therapy market: multi‑billion dollar opportunity driven by persistent gaps in control despite statin use; oral, well‑tolerated options could address patients who decline or cannot access injectable therapies.
- Patient population: Millions with elevated LDL‑C despite therapy-high residual risk segments include statin‑intolerant patients and those with heterozygous familial hypercholesterolemia (HeFH).
- Comparative positioning: Obicetrapib aims to offer a complementary or alternative profile to PCSK9 inhibitors and bempedoic acid by combining substantial LDL‑C lowering with oral convenience.
| Metric | Indicative value / Note |
|---|---|
| Primary R&D focus | Clinical development of obicetrapib through pivotal trials and regulatory submission pathways |
| Clinical investment intensity | Phase 3 programs and global trial execution imply multi‑year, multi‑tens to hundreds of millions USD development spend (typical for pivotal lipid programs) |
| Commercial opportunity | Large addressable market given prevalence of hypercholesterolemia and gaps in LDL‑C control; potential peak annual revenues in the multi‑hundreds of millions to billions USD range depending on uptake and pricing |
| Strategic priorities | Clinical evidence generation, regulatory engagement, payer access planning, and physician/patient adoption strategies |
- Project selection prioritizes therapies with demonstrable potential to meaningfully lower LDL‑C while maintaining favorable tolerability.
- Clinical trial designs emphasize robust LDL‑C endpoints, add‑on studies with statins, and inclusion of statin‑intolerant populations to demonstrate real‑world applicability.
- Patient engagement strategies focus on convenience (oral dosing), adherence support, and clear risk‑benefit communication tailored to clinicians and patients at high CVD risk.
- Pipeline transparency, clinical readouts, and corporate filings inform mission-aligned progress and capital allocation.
- Readers seeking deeper financial analysis can consult: Breaking Down NewAmsterdam Pharma Company N.V. Financial Health: Key Insights for Investors
NewAmsterdam Pharma Company N.V. (NAMSW) - Mission Statement
NewAmsterdam Pharma Company N.V. (NAMSW) is driven by a mission to develop and commercialize obicetrapib as a transformative LDL‑C lowering therapy that meaningfully reduces cardiovascular disease (CVD) morbidity and mortality worldwide. The mission aligns R&D, clinical development, regulatory strategy, commercial planning, and capital allocation to accelerate patient access to a novel oral CETP inhibitor when added to existing lipid‑lowering regimens.- Deliver an effective, well‑tolerated LDL‑C lowering option for patients inadequately controlled on statins and other therapies.
- Advance evidence generation through rigorous Phase 3 outcomes and safety studies to support broad guideline adoption.
- Create global commercial and access strategies to reach high‑risk patient populations across developed and emerging markets.
- Operate responsibly with financial discipline to extend runway and maximize shareholder value while prioritizing patient impact.
- Focus on patients not achieving LDL‑C goals with current standard of care (statins, ezetimibe, PCSK9 inhibitors).
- Prioritize large‑scale outcomes trials to demonstrate cardiovascular event reduction and secure guideline uptake.
- Scale global commercial capabilities to target both high‑income markets and high‑burden emerging regions.
- Maintain a consistent vision that guides capital raises, partnerships, and pipeline prioritization.
| Metric | Value / Rationale |
|---|---|
| Global burden of CVD (prevalent cases) | Approx. 523 million people living with CVD (2020, Global Burden of Disease) |
| Annual CVD deaths | ~18.6 million deaths globally (2020) |
| Estimated patients with uncontrolled LDL‑C despite therapy | Conservative estimate: 20-30% of high‑risk patients on statins/ezetimibe remain above target-tens of millions globally |
| Addressable market (patients seeking additional LDL‑C lowering) | Estimated 30-50 million patients in primary addressable markets (US, EU, China, Japan, selected EMs) |
| Projected market value for novel LDL‑C therapies | Range scenarios: $5B-$15B annual peak global sales (depending on uptake, price, and outcomes data) |
| Obicetrapib Phase 2 LDL‑C reduction | Reported placebo‑adjusted LDL‑C reductions in Phase 2 programs in the mid‑40s% range at higher doses (dose‑dependent) |
| Key commercialization milestones targeted | Complete Phase 3 trials, obtain regulatory approvals (US/EU/Asia), national reimbursement submissions, launch in major markets |
| Financial discipline | Capital strategy aimed at extending runway through critical value inflection points (Phase 3 readouts, regulatory filings, partnerships/licensing) |
- R&D: Concentrated investment in obicetrapib chemistry, formulation, and combination strategies to ensure competitive efficacy and tolerability.
- Clinical: Design of large‑scale event‑driven Phase 3 programs to demonstrate hard cardiovascular outcomes and support payer access.
- Regulatory & Access: Early engagement with regulators and HTA bodies to align on acceptable endpoints, labeling, and cost‑effectiveness evidence.
- Commercial: Segmented launch strategy-priority in cardiology/primary care in high‑risk cohorts, followed by expansion into broader lipid management populations.
| Metric | Target / Threshold |
|---|---|
| Phase 3 enrollment pace | Enroll pivotal trial within planned timeframe (e.g., 12-24 months depending on design) |
| Primary endpoint (post‑marketing objective) | Demonstrated statistically significant reduction in major adverse cardiovascular events (MACE) vs standard care |
| Commercial penetration year 3 post‑launch | Capture 10-20% share of patients needing additional LDL‑C lowering in target geographies (scenario‑based) |
| Revenue targets (illustrative) | Base case: $1B-$3B by peak years; Upside with outcomes data: $5B-$10B |
| Access goals | Reimbursement achieved in major markets within 12-24 months of approval |
- Patients: Prioritize safety, tolerability, and meaningful LDL‑C reductions to improve clinical outcomes.
- Clinicians: Provide robust evidence and practical tools to integrate obicetrapib into practice.
- Investors: Execute milestones that de‑risk the program and create scalable commercial value.
- Partners & payers: Demonstrate cost‑effectiveness and population health impact to secure access.
NewAmsterdam Pharma Company N.V. (NAMSW) - Vision Statement
NewAmsterdam Pharma Company N.V. (NAMSW) envisions a future where transformative, accessible therapies improve patient outcomes worldwide while setting a standard for ethical leadership, inclusive culture, and sustainable growth. The vision is grounded in measurable ambition: advancing a focused pipeline, scaling access to medicines, and delivering durable shareholder value through disciplined execution and innovation.- Patient-centric innovation: prioritize therapies addressing unmet medical needs with demonstrable clinical benefit and measurable health-economics impact.
- Equitable access: reduce barriers to treatment across markets through strategic partnerships, pricing models, and supply‑chain resilience.
- Sustainable growth: balance high‑impact R&D investment with capital discipline to drive long‑term financial stability.
- Inclusive leadership: cultivate a workplace where diverse perspectives accelerate problem‑solving and accountability.
- Excellence: implement quality metrics across clinical development and manufacturing; pursue regulatory milestones with clear timelines and RBE (risk‑benefit evaluation) frameworks.
- Integrity: maintain transparent reporting, third‑party audits, and governance practices that align actions with stated commitments.
- Inclusivity: target diversity and inclusion (D&I) benchmarks in hiring, promotion, and leadership representation.
- Open communication: standardize cross‑functional information flows, town halls, and feedback loops to reduce decision latency and increase employee engagement scores.
- Ownership & empowerment: delegate decision rights, set clear KPIs, and track adherence to timelines and outcomes.
- Bold innovation: encourage frontier science, external collaborations, and portfolio agility to capture unconventional growth opportunities.
| Domain | Industry Benchmark / Target | NAMSW Focus |
|---|---|---|
| Global pharma market (2023 est.) | $1.5 trillion | Target therapeutic niches with high unmet need and favorable reimbursement dynamics |
| R&D spend (pharma median) | ~15-20% of revenue | Prioritize capital allocation to late‑stage candidates and high-conviction earlier assets |
| Time to Phase III | Typically 6-8 years from discovery | Accelerate via adaptive trial designs and biomarker‑driven cohorts |
| Clinical success rates (phase I→approval) | ~9-12% overall; higher in targeted/biologic areas | De‑risk programs through translational validation and strategic partnerships |
| Diversity & Inclusion targets | Industry push for 30-40% underrepresented groups in leadership | Implement hiring pipelines and mentorship to reach internal D&I milestones |
| Supply continuity | Target <2% disruption events annually | Dual sourcing, buffer inventories, and regional manufacturing strategies |
| Commercial access | Reimbursement coverage target: formulary placement in top 5 markets within 18 months post‑launch | HEOR planning and payer engagement from Phase II onward |
- Governance: Board oversight aligned with fiduciary duties, independent audit and risk committees, and clear disclosure policies.
- Financial stewardship: capital allocation framework balancing R&D intensity with cash runway preservation and strategic partnering/licensing to derisk programs.
- Performance tracking: cadence of KPI reviews tied to R&D milestones, commercial readiness, compliance, and ESG metrics.
- Inclusive hiring: measurable recruitment targets and retention initiatives to ensure representation and equitable opportunity.
- Empowerment & ownership: decision‑making frameworks enabling managers and individual contributors to act with accountability.
- Continuous learning: invest in upskilling, cross‑functional rotations, and scientific exchange to sustain innovative capability.

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