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NewAmsterdam Pharma Announces Three Presentations at the 2026 American College of Cardiology Annual Scientific Session
Globenewswire· 2026-03-23 12:00
Core Insights - NewAmsterdam Pharma is presenting data on obicetrapib, a novel oral low-dose therapy for hypercholesterolemia, at the American College of Cardiology Annual Scientific Session [1] Group 1: Presentation Details - The presentation titled "CETP Inhibition with Obicetrapib Preserved Kidney Function in Patients at High Cardiovascular Risk: Results from the BROADWAY Trial" will take place on March 28, 2026 [2] - Another presentation titled "Safety of Obicetrapib: An Integrated Pooled Phase III Safety Analysis" is scheduled for March 29, 2026 [2] - A third presentation titled "Cardiovascular Events in People with Normal Low-Density Lipoprotein Cholesterol Levels but Discordantly High Levels of Small/Medium LDL Particles" will occur on March 30, 2026 [2] Group 2: About Obicetrapib - Obicetrapib is a CETP inhibitor developed to address limitations of current LDL-lowering treatments, showing statistically significant LDL-lowering effects in multiple Phase 2 and Phase 3 trials [3] - The Phase 3 PREVAIL trial, assessing obicetrapib's potential to reduce major adverse cardiovascular events (MACE), completed enrollment with over 9,500 patients [3] - Commercialization rights for obicetrapib in Europe have been granted to the Menarini Group [3] Group 3: About NewAmsterdam - NewAmsterdam Pharma focuses on improving patient care for metabolic diseases where existing therapies are inadequate or poorly tolerated [4] - The company is investigating obicetrapib as a once-daily CETP inhibitor, either alone or in combination with ezetimibe, for patients at risk of cardiovascular disease [4]
NewAmsterdam Pharma Company (NasdaqGM:NAMS) FY Conference Transcript
2026-03-03 16:32
Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Event**: FY Conference on March 03, 2026 Key Industry Insights - **Market Size**: The unmet need for LDL-lowering therapies is significant, with an estimated 30 million patients requiring treatment. The latest data indicates that achieving LDL levels below 55 is crucial for reducing total mortality, expanding the target population for combination therapies [4][5] - **Lipid Market Growth**: The lipid market is experiencing substantial growth, particularly in the branded segment, driven by more aggressive treatment targets and guidelines. The introduction of oral therapies is expected to further accelerate this growth [10][11] Core Product Insights - **Obicetrapib**: NewAmsterdam's lead drug, obicetrapib, is positioned as a differentiated LDL-lowering therapy with several key benefits: - **LDL Reduction**: Comparable LDL reductions to injectable therapies, with a significant reduction in small LDL particles by 90% [6][14][45] - **HDL Increase**: A 150% increase in HDL levels, which is associated with a lower risk of diabetes and potential benefits in Alzheimer's disease prevention [6][14][19] - **Lp(a) Lowering**: A 50% reduction in Lp(a) levels, targeting a population that may not qualify for existing injectable therapies [7][36] Clinical Trial Highlights - **BROADWAY Trial**: Demonstrated a 21% MACE benefit at 12 months, with a consistent LDL-lowering effect. The trial's design aligns closely with the upcoming PREVAIL trial, which is expected to validate these findings [3][12][15][23] - **Future Trials**: The PREVAIL trial is anticipated to provide further evidence of obicetrapib's efficacy, with a focus on achieving a positive MACE benefit to ensure broad uptake among clinicians [21][30] Regulatory and Commercial Strategy - **European Launch**: NewAmsterdam plans to launch obicetrapib in Europe, with regulatory approval expected by the end of 2026. The partnership with Menarini is seen as advantageous for market entry and reimbursement strategies [21][61][63] - **Market Differentiation**: The company aims to position obicetrapib as the first Lp(a)-lowering therapy in Europe, which could enhance its competitive edge [60][61] Financial Insights - **Funding and Milestones**: NewAmsterdam has secured $730 million in financing, with expectations to achieve significant sales milestones through its partnership with Menarini [4][61] - **Market Potential**: The potential market for obicetrapib is vast, with estimates suggesting it could serve tens of millions of patients, especially as treatment guidelines evolve [79] Additional Considerations - **Alzheimer's Disease Focus**: The potential for obicetrapib to impact Alzheimer's disease is highlighted as a significant opportunity, with market research indicating strong motivation among patients for effective treatments [18][78] - **Diabetes Risk**: Unlike statins, obicetrapib has shown a reduction in the risk of new-onset diabetes, which is a critical differentiator in the LDL-lowering market [14][30] Conclusion NewAmsterdam Pharma is positioned to capitalize on the growing demand for effective LDL-lowering therapies through its innovative product, obicetrapib. The company's strategic focus on clinical validation, regulatory approval, and market differentiation is expected to drive its success in the competitive landscape of lipid management.
NewAmsterdam Pharma to Present at the Guggenheim Emerging Outlook: Biotech Summit
Globenewswire· 2026-02-04 13:00
Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1] Company Overview - NewAmsterdam Pharma aims to improve patient care in populations with metabolic diseases where existing therapies are inadequate or poorly tolerated [3] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, in multiple phase 3 trials as a LDL-C lowering therapy [3] - Obicetrapib is being studied both alone and in fixed-dose combinations with ezetimibe, intended as an adjunct to statin therapy for patients with elevated LDL-C [3]
NewAmsterdam Pharma to Participate at Upcoming Investor Conferences in December
Globenewswire· 2025-11-25 13:00
Core Insights - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C levels [1][3] - The company aims to address the unmet need for safe and well-tolerated LDL-lowering therapies, particularly for patients who do not respond adequately to existing treatments [3] Upcoming Investor Conferences - NewAmsterdam management will participate in the 8th Annual Evercore Healthcare Conference on December 2, 2025, with CFO Ian Somaiya speaking at 3:50 p.m. ET [4] - The company will also be present at Citi's 2025 Global Healthcare Conference on December 3, 2025, where CEO Michael Davidson and CFO Ian Somaiya will speak at 3:15 p.m. ET [4] - Additionally, NewAmsterdam will attend the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025, with CEO Michael Davidson and CFO Ian Somaiya participating at 8:00 a.m. ET [4] Company Overview - NewAmsterdam Pharma is dedicated to improving patient care in populations with metabolic diseases where current therapies are insufficient or poorly tolerated [3] - The company is conducting multiple phase 3 trials for obicetrapib, an oral, low-dose CETP inhibitor, which is being tested alone and in combination with ezetimibe as an adjunct to statin therapy [3]
NewAmsterdam Pharma Provides Corporate Update and Reports Third Quarter Financial Results
Globenewswire· 2025-11-05 13:00
Core Insights - NewAmsterdam Pharma is focused on advancing obicetrapib, a novel oral therapy for lowering LDL-C in patients at risk of cardiovascular disease, with recent regulatory milestones achieved in Europe [2][7][11] Clinical Development Updates - The European Medicines Agency has accepted marketing authorization applications for obicetrapib and its fixed-dose combination with ezetimibe, marking a significant regulatory milestone [2][7] - Ongoing clinical trials include PREVAIL, a cardiovascular outcomes trial with over 9,500 patients enrolled, and REMBRANDT, a Phase 3 imaging trial [9][11] - Recent data from the BROADWAY trial indicates obicetrapib's potential to modify Alzheimer's disease biomarkers, particularly in high-risk patients [5][13] Financial Performance - As of September 30, 2025, NewAmsterdam reported cash, cash equivalents, and marketable securities totaling $756.0 million, a decrease from $834.2 million at the end of 2024 [10][21] - Revenue for the third quarter of 2025 was $0.3 million, down from $29.1 million in the same period in 2024, primarily due to the absence of clinical milestone revenue [10][23] - Research and development expenses decreased to $31.0 million from $35.7 million year-over-year, while selling, general, and administrative expenses increased to $24.5 million from $18.4 million [10][23] Market Context - Cardiovascular disease remains a leading cause of death globally, with a significant unmet need for effective LDL-C lowering therapies, as many patients do not achieve their LDL-C goals despite existing treatments [12][14] - The company aims to address this gap with obicetrapib, which has shown promising results in clinical trials, indicating its potential as a differentiated therapy in a growing market [2][11]
ESPR Stock Drops 17% on Pricing of $75M Common Stock Offering
ZACKS· 2025-10-09 14:01
Core Insights - Esperion Therapeutics (ESPR) is conducting a secondary offering of 30 million shares at $2.50 per share, aiming to raise approximately $75 million in gross proceeds [1][7] - The stock price fell nearly 17% following the announcement due to the discounted pricing, which was 19% below the previous closing price of $3.09 [2][7] - The proceeds from the offering will be used to expand the commercial reach of marketed drugs Nexletol and Nexlizet, support clinical development, and for general corporate purposes [4][7] Financial Details - The secondary offering is expected to close today, with net proceeds estimated at $70.2 million after expenses [1] - The underwriters have an option to purchase an additional 4.5 million shares at the same price [1] Product Information - Nexletol and Nexlizet are marketed for treating elevated LDL-C and cardiovascular risk reduction, with Nexlizet being a combination of bempedoic acid and ezetimibe [5] - The company has settled patent litigation with Dr. Reddy's Laboratories, preventing the launch of generic versions of its drugs until April 19, 2040 [6] Legal Context - Esperion has signed similar agreements with other generic drugmakers, ensuring that they cannot market generics of Nexletol or Nexlizet until 2040 [8] - Ongoing patent litigation remains with other generic challengers, including Sandoz, Aurobindo Pharma, and MSN Pharmaceuticals [8] Market Performance - Year-to-date, ESPR's stock has gained 17%, outperforming the industry average growth of 10% [2]
Esperion Reaches Settlement Agreement with ANDA Filer, Dr. Reddy's Laboratories, Not to Market Generic Versions of NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Prior to April 19, 2040
Globenewswire· 2025-10-03 12:00
Core Insights - Esperion has entered into a settlement agreement with Dr. Reddy's Laboratories, resolving patent litigation regarding generic versions of NEXLETOL and NEXLIZET, preventing Dr. Reddy's from marketing these generics in the U.S. before April 19, 2040, unless specific circumstances arise [1] - The settlement with Dr. Reddy's follows previous agreements with Micro Labs USA, Hetero USA, and Accord Healthcare concerning their generic versions of NEXLETOL, ensuring no remaining challenges to the validity of U.S. Patent No. 7,335,799, which expires in December 2030 [2] - Ongoing patent litigation against other defendants remains, with uncertainty regarding the potential for generic versions of NEXLETOL and NEXLIZET to be marketed before the April 2040 date [3] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing FDA-approved oral medications for patients at risk for cardiovascular disease, specifically targeting elevated low-density lipoprotein cholesterol (LDL-C) [4] - The company is advancing its pre-clinical pipeline and aims to establish itself as a leading global biopharmaceutical entity through commercial execution and international partnerships [5]
NewAmsterdam Pharma to Present at the Stifel 2025 Virtual Cardiometabolic Forum
Globenewswire· 2025-09-24 12:00
Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1][3] Company Overview - NewAmsterdam Pharma aims to address unmet needs in metabolic diseases where current therapies are inadequate or poorly tolerated [3] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, in multiple phase 3 trials [3] - Obicetrapib is being studied as an LDL-C lowering therapy, either alone or in combination with ezetimibe, to be used alongside statin therapy for patients with elevated LDL-C [3] Upcoming Events - John Kastelein and Matthew Philippe will participate in a virtual fireside chat at the Stifel 2025 Virtual Cardiometabolic Forum on September 30, 2025 [1] - A live webcast of the event will be available on the investor relations section of the NewAmsterdam Pharma website, with an archived replay to follow [2]
Esperion’s Bempedoic Acid Receives Level 1a Recommendation in Updated ESC/EAS Guidelines for Management of Dyslipidaemias
Globenewswire· 2025-08-29 12:00
Core Insights - Bempedoic acid has received strong endorsement from the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) guidelines as the only non-statin recommended for lowering LDL-C and reducing cardiovascular risk [1][4] - The guidelines emphasize an early and aggressive approach to combination lipid-lowering therapy, which aligns with the company's strategy to develop oral triple combination therapies in the U.S. [1][5] Company Developments - Esperion's President and CEO highlighted the significance of the guideline recognition for both European and U.S. markets, indicating that it will inform upcoming U.S. cholesterol treatment guidelines [2] - The company is strategically positioned to lead in the development of the first oral lipid-lowering triple combination pill in the U.S., which aims to provide unprecedented LDL-C lowering and improved patient adherence [5][16] Product Information - NEXLIZET and NEXLETOL are indicated for patients unable to take statin therapy, with bempedoic acid recommended for achieving LDL-C goals [6][7] - The guidelines recommend the addition of bempedoic acid to maximally tolerated doses of statins for high-risk patients to achieve LDL-C goals [6] Clinical Evidence - The clinical benefits of bempedoic acid are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial, which validates its role in cardiovascular risk reduction [16]
NewAmsterdam Announces Acceptance of Marketing Authorization Applications for Review by European Medicine Agency for Obicetrapib
GlobeNewswire News Room· 2025-08-18 12:00
Core Viewpoint - NewAmsterdam Pharma has submitted Marketing Authorization Applications (MAAs) for obicetrapib monotherapy and its fixed-dose combination with ezetimibe to the European Medicines Agency (EMA) for treating primary hypercholesterolemia and mixed dyslipidemia, marking a significant step in providing new LDL-C lowering therapies for patients at risk of cardiovascular disease [1][2][3] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients with elevated low-density lipoprotein cholesterol (LDL-C) who are at risk of cardiovascular disease [1][6] - The company aims to address unmet needs in LDL-lowering therapies that are safe, well-tolerated, and convenient for patients [6] Product Development - Obicetrapib is a novel, oral, low-dose cholesteryl ester transfer protein (CETP) inhibitor, which has shown statistically significant LDL-C reductions in multiple Phase 3 trials, including BROADWAY, BROOKLYN, and TANDEM [2][5] - The BROADWAY trial reported a 33% reduction in LDL-C compared to placebo, while the TANDEM trial achieved a 49% reduction, demonstrating the efficacy of obicetrapib both as a monotherapy and in combination with ezetimibe [7] Partnership and Financials - NewAmsterdam has an exclusive licensing agreement with Menarini for the commercialization of obicetrapib in Europe, which includes an upfront payment of €115 million and potential milestone payments totaling up to €863 million [3][4] - The company is entitled to tiered double-digit percentage royalties on net sales in the Menarini territory, ranging from low double-digits to mid-twenties [1][3] Market Context - Cardiovascular disease remains the leading cause of death globally, with an estimated 17.9 million deaths annually, highlighting the need for effective LDL-lowering therapies [3] - Despite the availability of lipid-lowering therapies, many patients do not achieve their LDL-C targets, indicating a significant market opportunity for new treatments like obicetrapib [3][6]