Core Insights - NewAmsterdam Pharma Company N.V. (NAMS) shares increased by 5.9% to $32.48, with a notable trading volume, reflecting a 13.6% gain over the past four weeks [1][2] Company Overview - The rise in NAMS stock price is linked to investor optimism surrounding its investigational candidate, obicetrapib, which is being evaluated for lowering LDL-C in patients with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia across three pivotal late-stage studies [2] Financial Expectations - The company is projected to report a quarterly loss of $0.41 per share, marking a year-over-year decline of 127.8%, with expected revenues of $2.35 million, down 91.9% from the previous year [3] - The consensus EPS estimate for NAMS has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - NAMS operates within the Zacks Medical - Drugs industry, where another company, Stevanato Group (STVN), experienced a 5.6% decline in stock price, closing at $24.53, despite a 7.6% return over the past month [4] - Stevanato's consensus EPS estimate has remained stable at $0.15, reflecting a year-over-year increase of 15.4%, and it holds a Zacks Rank of 2 (Buy) [5]

Summary of NewAmsterdam Pharma Conference Call Company Overview - **Company**: NewAmsterdam Pharma (NasdaqGM:NAMS) - **Key Personnel**: Founder and Chief Scientific Officer John Kastelein, Head of Investor Relations and Executive Vice President Matthew Philippe - **Focus**: Development of lipid-lowering therapies, particularly obicetrapib Core Points and Arguments - **Clinical Trials**: - Completed pivotal lipid-lowering registration studies: BROADWAY, BROOKLYN, and TANDEM, all published in reputable journals [2][3] - Current focus on PREVAIL trial, which is fully enrolled and aims to translate findings from BROADWAY, showing a 21% reduction in major adverse cardiovascular events (MACE) [2][3] - PREVAIL has four times the number of patients and a longer duration than BROADWAY, enhancing confidence in MACE reduction outcomes [3] - **Regulatory Filings**: - Applications filed in Europe for both monotherapy and fixed-dose combination, with expected approvals in the second half of next year [6] - U.S. filing timelines are contingent on PREVAIL outcomes data, with hopes for data availability by early 2026 [7][8] - **Efficacy Data**: - The 21% MACE reduction observed in BROADWAY is supported by Kaplan-Meier curves, indicating biological plausibility [10][11] - Analysis of previous trials suggests that MACE reductions in phase three trials typically translate to outcomes in larger trials [12] - **Lipid Dynamics**: - Focus on small LDL particles and lipoprotein(a) as significant contributors to cardiovascular risk, with obicetrapib showing a 90% reduction in small LDL particles [16][18] - Ongoing studies to establish the predictive value of LDL particles over traditional LDL cholesterol measurements [17] - **Lipoprotein(a) Insights**: - Anticipation of positive outcomes from the HORIZON trial, which will assess the impact of lipoprotein(a) lowering on MACE [20][21] - The relationship between lipoprotein(a) reduction and MACE is expected to be established, aiding in the understanding of obicetrapib's effects [21][22] - **Competitive Landscape**: - NewAmsterdam Pharma positions obicetrapib as the only CETP inhibitor, differentiating it from existing PCSK9 inhibitors [36][37] - Emphasis on the safety profile of obicetrapib as a key factor for broad market access [38] Other Important Content - **Alzheimer's Disease Biomarker Study**: Recent findings suggest obicetrapib may also impact Alzheimer's disease biomarkers, presenting a unique selling point [4][41] - **Patient Compliance and Trial Integrity**: The company has established robust tracking mechanisms for patient compliance in the PREVAIL trial, ensuring data integrity [31][34] - **Market Potential**: The lipid management market is expected to accommodate multiple successful therapies, with NewAmsterdam Pharma aiming for a significant share due to its differentiated product profile [36][38] This summary encapsulates the key discussions and insights from the NewAmsterdam Pharma conference call, highlighting the company's strategic direction, clinical trial progress, and competitive positioning in the lipid-lowering market.

NAARDEN, The Netherlands and MIAMI, Sept. 24, 2025 (GLOBE NEWSWIRE) -- 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 that John Kastelein, Chief Scientific Officer, and Matthew P ...

Core Insights - Several healthcare and biotech stocks saw significant price movements in after-hours trading on September 12, with notable gains in companies like Penumbra, Check-Cap, Adaptimmune Therapeutics, and NewAmsterdam Pharma, indicating a volatile session for the sector [1] Company Summaries Penumbra Inc. (PEN) - Penumbra's stock closed at $272.73 during regular trading, down by $3.67 or 1.33%, but rebounded to $289.86 in after-hours, gaining 6.28% [2] - The trading range for the day was $271.83 to $280.14, with a volume of 454,478 shares, slightly below its average of 472,087 [3] - The company has a market capitalization of approximately $10.64 billion and a trailing price-to-earnings ratio of 71.96 based on earnings per share of $3.79 [3] - Penumbra raised its full-year 2025 revenue guidance to $1.355 billion - $1.370 billion, reflecting a growth of 13% - 15% over 2024 revenue of $1.195 billion, and projects a 20% - 21% growth in its U.S. thrombectomy segment [5] - The company appointed Shruthi Narayan as its new president, indicating potential strategic shifts [6] Check-Cap Ltd. (CHEK) - Check-Cap's stock surged from $0.7459 to $2.1600 in after-hours trading, marking a gain of 191.22%, driven by a strategic merger announcement [6] - During regular trading, the stock gained 8.09%, closing at $0.7459, with a trading range of $0.6860 to $0.7602 and a volume of 67,178 shares [7] - The merger with MBody AI aims to enhance Check-Cap's colorectal cancer screening capabilities through AI integration [8] Adaptimmune Therapeutics plc (ADAP) - Adaptimmune's stock rose from $0.0560 to $0.0651 in after-hours trading, a gain of 16.25%, following a 10.89% increase during regular hours [8] - For Q2 2025, the company reported a net loss of $30.3 million, or $0.02 per share, with total revenue of $13.7 million, primarily from product sales of TECELRA [9] - Adaptimmune entered a definitive agreement to sell certain cell therapies for $55 million upfront, with potential future milestone payments of up to $30 million, allowing it to repay debt and restructure for value maximization [10] NewAmsterdam Pharma Company N.V. (NAMS) - NewAmsterdam's shares rose from $24.19 to $26.18 in after-hours trading, an 8.23% gain, following a 9.06% decline during the day [11] - The stock's recovery is attributed to optimism surrounding its lead candidate, obicetrapib, which has received regulatory review acceptance from the EMA [11] - The company reported Q2 2025 revenue of $16.45 million and a net loss of $14.92 million, improving from a $0.41 loss per share in the same quarter of 2024 [13]

Financial Data and Key Metrics Changes - The company has achieved significant milestones in its LDL studies, with positive data released last year supporting its European filing accepted by the EMA [3][4] - The expected approval in Europe is anticipated within the next 12 months, with a projected 33% to 36% reduction in LDL-C for monotherapy and approximately 49% for the fixed-dose combination [8][10] Business Line Data and Key Metrics Changes - The company is focusing on redefining hyperlipidemia treatment through its drug obicetrapib, which not only reduces LDL but also Lp(a) by 40% to 50% in targeted patient populations [4][5] - The BROADWAY trial demonstrated a 21% MACE benefit at one year, indicating the drug's potential effectiveness [34] Market Data and Key Metrics Changes - The global opportunity for the drug is projected to exceed $8 billion, with potential revenue splits favoring the U.S. market [16][17] - The company expects a slower launch pace in Europe compared to the U.S. due to country-by-country approval processes [18] Company Strategy and Development Direction - The company aims to leverage its unique drug profile to gain a competitive edge in the lipid-lowering market, particularly against PCSK9 inhibitors and other therapies [44][45] - The strategy includes a focus on broad access and pricing negotiations in Europe, with a collaborative relationship with its partner Menarini [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's potential to address residual risks associated with small LDL particles, which are not effectively targeted by existing therapies [5][46] - The company is optimistic about the upcoming PREVAIL study results, which are expected to support its U.S. filing strategy [25][34] Other Important Information - The company has secured a new composition of matter patent valid until 2043, enhancing its intellectual property position [60] - The management highlighted the importance of outcomes data in shaping the drug's market access and pricing strategies [20][23] Q&A Session Summary Question: Can you provide an overview of the company and upcoming investor focus areas? - The company was founded to redefine hyperlipidemia treatment, with significant progress in LDL studies and an upcoming outcome study [3][4] Question: What are the expectations for the European regulatory submission? - The submission is based on the BROADWAY and BROOKLYN studies, with expected LDL-C reductions of 33% to 36% for monotherapy [8][10] Question: How does the company plan to approach U.S. filing strategies? - The company aims to launch with the broadest possible label, leveraging outcomes data to enhance market access [20][21] Question: What is the competitive landscape for obicetrapib? - The drug is positioned to outperform existing therapies by addressing both LDL and Lp(a) levels effectively [44][45] Question: What is the company's confidence in its intellectual property position? - The company has a strong IP estate, including a new patent valid until 2043, which supports its market position [60]

Financial Data and Key Metrics Changes - The company expects approval in Europe within the next 12 months, with a projected 33% to 36% reduction in LDL-C for monotherapy and approximately 49% for the fixed-dose combination [8][10] - The global market opportunity for the drug is estimated to exceed $8 billion, with potential revenue splits favoring the U.S. [17][18] Business Line Data and Key Metrics Changes - The company has initiated three LDL studies, with positive data released last year supporting the European filing accepted by the EMA [3][4] - The drug shows a unique ability to reduce Lp(a) by 40% to 50%, which is significantly higher than existing therapies [4][47] Market Data and Key Metrics Changes - The pricing strategy in Europe will be determined by the partner Menarini, with a focus on broad access to lipid-lowering therapies [12][16] - The company anticipates a slower launch pace in Europe compared to the U.S. due to country-by-country approval processes [19][20] Company Strategy and Development Direction - The company aims to redefine hyperlipidemia treatment with its drug, focusing on both LDL and Lp(a) reduction [3][4] - The strategy includes leveraging outcomes data to enhance market access and pricing negotiations in the U.S. [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's unique characteristics and its potential to resonate with both clinicians and patients [5][48] - The company is optimistic about the PREVAIL study's outcomes, expecting to report a MACE benefit of over 20% [35][36] Other Important Information - The company has a strong intellectual property position, with patents extending to 2043 in the U.S. [60] - The collaboration with Menarini is seen as beneficial due to their established presence in the cardiovascular space [17] Q&A Session Summary Question: What is the expected timeline for EU approval? - The company expects approval in the next 12 months, with the outcome study not being a gating factor for the approval process [10][11] Question: How does the pricing strategy work in Europe? - The pricing will be determined by Menarini, with a focus on broad access within established price bands for lipid-lowering therapies [12][16] Question: What is the rationale behind the U.S. filing strategy? - The company aims to launch with the broadest possible label, leveraging outcomes data to enhance market access [22][24] Question: How does the company differentiate its drug from existing therapies? - The drug offers significant reductions in both LDL and Lp(a), addressing residual risks that current therapies do not [47][48] Question: What is the confidence level in the intellectual property position? - The company is confident in its IP estate, with patents in place until 2043 [60]

NAARDEN, The Netherlands and MIAMI, Aug. 25, 2025 (GLOBE NEWSWIRE) -- 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 that it will present additional pooled safety and efficacy da ...

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]

Core Insights - NewAmsterdam Pharma is advancing its oral, low-dose CETP inhibitor obicetrapib, targeting cardiovascular disease and Alzheimer's pathology, with significant clinical data supporting its efficacy [3][4][10] - The company reported a substantial increase in revenue for Q2 2025, recognizing $19.1 million compared to $2.3 million in Q2 2024, primarily due to development cost contributions from Menarini [7][19] - NewAmsterdam's cash position as of June 30, 2025, was $783.3 million, down from $834.2 million at the end of 2024, reflecting ongoing operating expenditures [7][19] Clinical Development Updates - The PREVAIL Phase 3 cardiovascular outcomes trial has completed enrollment of over 9,500 patients, focusing on those with a history of ASCVD [9][10] - Positive topline data from the BROADWAY trial indicated a statistically significant reduction in p-tau217 levels, a key Alzheimer's biomarker, in patients treated with obicetrapib [4][12] - The company plans to launch the Phase 3 RUBENS trial later in 2025, evaluating obicetrapib in combination with ezetimibe for patients with type 2 diabetes and metabolic syndrome [3][4] Financial Performance - NewAmsterdam reported a net loss of $17.4 million for Q2 2025, an improvement from a net loss of $39.0 million in Q2 2024 [7][19] - Research and development expenses decreased to $27.5 million in Q2 2025 from $38.4 million in the same period in 2024, attributed to reduced clinical expenses [7][19] - Selling, general, and administrative expenses rose to $27.3 million in Q2 2025, up from $16.5 million in Q2 2024, driven by increased personnel costs and marketing investments [7][19] Market Context - Cardiovascular disease remains a leading global health issue, with a projected increase in affected U.S. adults to over 184 million by 2050, highlighting the need for effective LDL-C lowering therapies [11] - Despite the availability of lipid-lowering therapies, many patients remain undertreated, with only 10% of very high-risk ASCVD patients achieving LDL-C goals below 55 mg/dL [11] - The company aims to address this unmet need with obicetrapib, which has shown promising LDL-C reduction and a favorable safety profile in clinical trials [10][11]

Core Insights - NewAmsterdam Pharma's obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's disease biomarker, in both the full analysis set and in ApoE4 carriers, indicating its potential as a novel approach to Alzheimer's prevention [1][3][13] - In ApoE4/E4 carriers, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo [1][4][5] - The results support obicetrapib's cardiometabolic profile, showing reductions in LDL-C and other cardiovascular risk factors [1][2][15] Company Overview - 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 [1][16] - The company aims to address unmet needs in populations where current therapies are inadequate or poorly tolerated [16] - Obicetrapib is being evaluated in multiple clinical trials, including the pivotal Phase 3 BROADWAY trial, which assesses its efficacy and safety in patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia [2][10][15] Clinical Trial Insights - The BROADWAY trial included 2,530 patients and was designed to evaluate the LDL-C lowering efficacy of obicetrapib [2][10] - A prespecified analysis of the trial assessed the effects of obicetrapib on plasma biomarkers of Alzheimer's disease in 1,515 patients, including 367 ApoE4 carriers [2][13] - The primary outcome measure was the absolute and percent change in p-tau217 over 12 months, with significant reductions observed [3][13] Biomarker Analysis - Statistically significant reductions in p-tau217 levels were observed in both the full analysis set and ApoE4 carriers, with p-values of 0.0019 and 0.0215, respectively [1][3][13] - Additional favorable trends were noted across other biomarkers, including NFL, GFAP, and p-tau181 [3][4][6] - The analysis highlights the potential of obicetrapib to influence Alzheimer's disease risk through lipid modulation, particularly in high-risk ApoE4 carriers [7][13] Future Directions - NewAmsterdam plans to discuss the results with regulatory authorities to determine potential next steps for obicetrapib [7][18] - The company is also exploring the commercialization rights of obicetrapib in Europe, which have been granted to the Menarini Group [15][16]