"All there is to investing is picking good stocks at good times and staying with them as long as they remain good companies", said Warren Buffet, reminding us that patience and discipline are key to successful investing. Stocks quietly climbing to new 52-week highs could be a sign that the market is recognizing consistent performance, strong fundamentals, or upcoming catalysts.The following are some of the stocks that hit new 52-week highs yesterday. Do you already own any of them? Are any on your watchlis ...

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.

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]

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]

Core Insights - The Citi Back-to-school Biopharma Conference is being held for the 20th annual time, indicating its significance in the biopharma industry [1] - The conference features key executives from NewAmsterdam, including the CEO and CFO, highlighting the company's involvement and progress in the sector [1][2] Company Highlights - NewAmsterdam has made significant advancements in Phase III clinical trials, showcasing its commitment to research and development in biopharma [2]

Summary of NewAmsterdam Pharma Company (NAMS) Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Event**: Citi Back to School Biopharma Conference - **Date**: September 03, 2025 Key Points Industry and Product Development - NewAmsterdam Pharma has made significant progress in Phase III trials, particularly with obicetropib, demonstrating a 21% reduction in major adverse cardiovascular events (MACE) and showing safety comparable to placebo [3][5] - The company has published multiple studies in prestigious journals, including the New England Journal of Medicine and Lancet, highlighting the efficacy of their drug in lowering LDL and other cardiovascular risk factors [4][5] - The PREVAIL trial is fully enrolled and on track to finish late next year, with positive recommendations from Data Safety Monitoring Board (DSMB) meetings [5][34] Clinical Data and Efficacy - The drug not only lowers LDL but also shows benefits in lowering LpLA, small particles, and diabetes risk, with additional promising results in Alzheimer's biomarkers for APOE4 patients [6][20] - The company is optimistic about the drug's potential to provide significant benefits in Alzheimer's treatment, particularly for high-risk patients [22][50] - The totality of data suggests that the drug could be positioned as a foundational therapy in cardiometabolic health, with potential for combination therapies [55][64] Market Position and Strategy - NewAmsterdam Pharma aims to address skepticism in the cardiology community regarding CTP inhibitors by emphasizing clinical data and outcomes from ongoing trials [12][14] - The company is actively engaging with payers to ensure favorable reimbursement and access for their drug upon launch [16][17] - The strategy includes a focus on the LDL-lowering benefits as the cornerstone of the drug's value proposition, while also promoting its additional benefits [76] Future Development and Partnerships - The company plans to pursue partnerships in Asia (Japan and China) while maintaining control over the U.S. market to maximize shareholder value [89][90] - NewAmsterdam Pharma is looking for partners with a strong cardiovascular presence, particularly in primary care, to help commercialize their product effectively [92][95] - The company is also exploring the potential for combination therapies with other drugs, such as GLP-1 and SGLT-2 inhibitors, to enhance diabetes prevention and cardiovascular outcomes [72][74] Regulatory and Market Considerations - The company has filed for EMA approval in Europe, which was accepted, and is preparing for potential FDA discussions regarding accelerated approval based on their clinical data [5][88] - NewAmsterdam Pharma is aware of the regulatory environment and is strategizing to navigate challenges, including the potential impact of the pill penalty on oral medications [81][84] Conclusion - NewAmsterdam Pharma is positioned to make a significant impact in the biopharma industry with its innovative drug, obicetropib, which addresses both cardiovascular and potential Alzheimer's disease pathways. The company is focused on leveraging clinical data, engaging with stakeholders, and exploring strategic partnerships to maximize the drug's market potential and patient access [3][19][88]

Core Insights - NewAmsterdam Pharma is set to present additional pooled safety and efficacy data from the pivotal Phase 3 BROADWAY and BROOKLYN trials at the European Society of Cardiology Congress (ESC) from August 29 to September 1, 2025 [1] - The company is focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1][5] Presentation Details - The first presentation titled "Efficacy of obicetrapib across the spectrum of background lipid lowering therapies-pooled analyses of the Broadway and Brooklyn randomized trials" will take place on August 29, 2025, at 10:10 am CEST [2] - A second presentation titled "Obicetrapib and cardiovascular events" is scheduled for September 1, 2025, at 9:00 am CEST [3] Upcoming Investor Conferences - NewAmsterdam management will participate in several investor conferences, including: - Citi's 2025 Biopharma Back to School Summit on September 3, 2025, at 2:30 pm ET in Boston, MA [4] - Cantor Global Healthcare Conference on September 4, 2025, at 2:45 pm ET in New York, NY [4] - Wells Fargo Healthcare Conference on September 5, 2025, at 10:15 am ET in Boston, MA [4] - Live webcasts of these presentations will be available on the company's investor relations website [4]