NewAmsterdam Pharma pany N.V.(NAMS)

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NewAmsterdam Pharma Company (NAMS) 2025 Conference Transcript
2025-06-04 15:30
Summary of NewAmsterdam Pharma Company (NAMS) Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NAMS) - **Event**: Jefferies Healthcare Conference - **Date**: June 04, 2025 Key Points Industry and Market Context - The focus is on redefining the treatment of Atherosclerotic Cardiovascular Disease (ASCVD) beyond just LDL reduction to include other risk factors such as LpLA and diabetes [3][6][24] - There are approximately **70 million patients in the U.S.** with elevated LDL under treatment, indicating a vast market opportunity for NAMS's drug, obisetropib [10] Drug Development and Clinical Trials - NAMS has had **three positive Phase III trial readouts** last year, boosting confidence in regulatory approval and market entry [3] - The company is targeting additional conferences to present data that differentiates obisetropib from existing and developing drugs [4] - Obisetropib has shown an **average of 45% reduction in LpLA** in Phase III studies, addressing a significant patient population that does not qualify for existing LpLA-targeted therapies [13] Competitive Advantages - Obisetropib aims to address multiple cardiometabolic risk factors, including LDL, LpLA, and diabetes, making it a comprehensive treatment option [6][29] - The drug is positioned to potentially outperform existing therapies by significantly reducing small LDL particles, which are not effectively targeted by current treatments [37][38] Regulatory and Commercial Strategy - NAMS plans to engage with regulatory agencies to include LpLA in clinical trial sections, which could enhance the drug's marketability [15][16] - The company has raised approximately **$700 million** in financing, providing a strong balance sheet of about **$810 million** to support clinical trials and a planned U.S. launch around **2027** [52][53][54] Future Outlook - The ASCVD market is expected to evolve towards combination therapies and fixed-dose approaches, with obisetropib positioned as a preferred option due to its comprehensive risk factor management [24][28] - The company anticipates a **21% MACE benefit** based on recent data, which could significantly enhance its competitive position in the market [34][49] Additional Insights - NAMS is conducting a Phase II trial (Vinson study) to evaluate the combination of obisetropib with Amgen's Repatha, focusing on both LDL and LpLA reduction [14][19] - The company emphasizes the importance of safety and convenience in treatment options, aiming to provide a low-dose, once-daily pill for patients [32] Conclusion NewAmsterdam Pharma is strategically positioned to redefine ASCVD treatment with obisetropib, leveraging positive clinical trial results and a robust financial foundation to capture a significant share of the market. The focus on comprehensive risk factor management and engagement with regulatory bodies will be crucial for its future success.
NewAmsterdam Pharma Company (NAMS) FY Conference Transcript
2025-06-03 21:20
NewAmsterdam Pharma Company (NAMS) FY Conference June 03, 2025 04:20 PM ET Speaker0 Hi, everyone. Thanks for coming. My name is Matt Phipps, biotechnology analyst here at William Blair. I'm glad to announce happy to announce the next company at our Growth Stock Conference. It's New Amsterdam Pharma with Michael Davidson, one of the CEO and and cofounders. It's a, you know, company that's had a lot of success over the past, you know, really couple years, but really demonstrating some great clinical data with ...
NewAmsterdam Pharma to Participate at Upcoming Investor Conferences in June
GlobeNewswire· 2025-05-27 12:00
NAARDEN, the Netherlands and MIAMI, May 27, 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 company management will participate in the following upco ...
Wall Street Analysts Predict a 132.5% Upside in NewAmsterdam Pharma Company N.V. (NAMS): Here's What You Should Know
ZACKS· 2025-05-12 15:00
NewAmsterdam Pharma Company N.V. (NAMS) closed the last trading session at $18.37, gaining 21.5% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $42.71 indicates a 132.5% upside potential.The average comprises seven short-term price targets ranging from a low of $37 to a high of $52, with a standard deviation of $5.28. While the lowest estimate indicates an increase of 101.4% from ...
NewAmsterdam Pharma Company N.V. (NAMS) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-08 14:30
NewAmsterdam Pharma Company N.V. (NAMS) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to loss of $0.62 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8.89%. A quarter ago, it was expected that this company would post a loss of $0.48 per share when it actually produced a loss of $0.95, delivering a surprise of -97.92%.Over the last four quarters, the co ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2025 Q1 - Quarterly Report
2025-05-08 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41562 NewAmsterdam Pharma Company N.V. (Exact Name of Registrant as Specified in its Charter) | The Netherlands | N/A | | --- | - ...
NewAmsterdam Pharma pany N.V.(NAMS) - 2025 Q1 - Quarterly Results
2025-05-08 12:00
NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results – EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively -- -- Company to host R&D day on June 11 th , 2025 in New York City -- –$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 – Naarden, the Nethe ...
NewAmsterdam Pharma Provides Corporate Update and Reports First Quarter Financial Results
GlobeNewswire· 2025-05-08 12:00
– EMA submission expected in 2H25 by partner Menarini – – PREVAIL Phase 3 CVOT remains on track – -- BROADWAY and TANDEM results presented at EAS with simultaneous publications in the New England Journal of Medicine and The Lancet, respectively -- -- Company to host R&D day on June 11th, 2025 in New York City -- –$808.5 million in cash, cash equivalents and marketable securities at March 31, 2025 – NAARDEN, The Netherlands and MIAMI, May 08, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasda ...
NewAmsterdam Pharma Announces Late-Breaking Data from BROADWAY and TANDEM Pivotal Studies Published in Leading Medical Journals and Presented at the European Atherosclerosis Society (EAS) Congress 2025
GlobeNewswire· 2025-05-07 11:15
Core Insights - NewAmsterdam Pharma has presented compelling clinical data from the BROADWAY and TANDEM Phase 3 trials, demonstrating significant reductions in LDL-C and Lp(a) levels, which are critical for patients at risk of cardiovascular disease [1][2][6] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medications for patients with elevated LDL-C who are at risk of cardiovascular disease [1][13] - The company is investigating obicetrapib, a low-dose CETP inhibitor, as a potential adjunct therapy to statins for improving LDL-C levels [8][13] Clinical Trial Findings - The BROADWAY trial showed that obicetrapib reduced LDL-C by 50% when used with statins and by 35% as monotherapy, with a notable 21% reduction in major adverse cardiovascular events [4][5] - The TANDEM trial demonstrated that the fixed-dose combination of obicetrapib and ezetimibe achieved a statistically significant LDL-C reduction of 48.6% compared to placebo [3][4] - Pooled data from the BROADWAY, TANDEM, and BROOKLYN trials indicated a median placebo-adjusted reduction of 45% in Lp(a) levels after 12 weeks of treatment [6][7] Market Context - Cardiovascular disease remains the leading cause of death globally, with a significant number of patients unable to reach their LDL-C goals despite the availability of lipid-lowering therapies [9][12] - Approximately 30 million under-treated adults in the U.S. are not at their risk-based LDL-C goal, highlighting a substantial clinical need for effective therapies [12] Future Prospects - The data presented at EAS 2025 is expected to support global regulatory filings for obicetrapib, reinforcing its potential as a foundational therapy in cardiovascular disease management [2][7] - The company has completed enrollment for the Phase 3 PREVAIL trial, which aims to assess the impact of obicetrapib on major adverse cardiovascular events [8]
NewAmsterdam Pharma to Present New Clinical and Preclinical Data at 93rd EAS Congress
GlobeNewswire· 2025-04-30 12:00
Presentations include new data from BROADWAY and TANDEM Phase 3 clinical trials, demonstrating obicetrapib’s impact on key lipid and lipoprotein biomarkersNAARDEN, the Netherlands and MIAMI, April 30, 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”), ...