U.S. IPE Market Leadership Sustained; $70M Restructuring OPEX Savings on Pace for Mid-2026; Completed Transition to Fully Partnered Model Across All International MarketsDUBLIN and BRIDGEWATER, N.J., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a company advancing the science of cardiovascular therapeutics worldwide, today announced select preliminary unaudited 2025 financial highlights, provided a summary of key 2025 operational accomplishments, and outlined 2026 priorities in ad ...

Summary of NewAmsterdam Pharma Company FY Conference Call Company Overview - **Company**: NewAmsterdam Pharma Company (NasdaqGM:NAMS) - **Event**: 37th Annual Healthcare Conference - **Date**: December 04, 2025 Key Points Industry and Product Development - **2026 Expectations**: The year is anticipated to be significant for NewAmsterdam, particularly with the PREVAIL CVOT study results expected in the second half of 2026 [3][4][6] - **Study Execution**: 2025 was marked by successful study executions and data releases, including publications in prestigious journals like the New England Journal of Medicine [4][5] Clinical Trial Insights - **Event Rate Tracking**: The company is monitoring event rates closely, with a projected relative risk reduction of 20% based on historical data from similar studies [5][6] - **Quality of Trials**: NewAmsterdam claims to exceed quality benchmarks in their trials, with a focus on maintaining patient retention and adherence [12][39] Regulatory and Commercial Strategy - **Regulatory Filings**: The European Medicines Agency (EMA) has accepted the regulatory filing for obicetrapib, with Menarini as the partner responsible for the launch in Europe [15][17] - **Pricing Strategy**: Menarini is conducting scenario planning for pricing, considering the drug's value in LDL lowering and other health benefits [17][18] Market Positioning and Launch Strategy - **NDA Filing**: The company plans to file a New Drug Application (NDA) in the first half of 2026, aiming to maximize the product label with outcome study data [19][20] - **Combination Studies**: Ongoing studies, such as the Tandem study, are exploring the combination of obicetrapib with PCSK9 inhibitors, which is crucial for positioning against competitors [22][24] Patient Engagement and Market Acceptance - **Patient Motivation**: The drug is expected to resonate well with patients due to its multifaceted benefits, including LDL-C lowering, diabetes prevention, and potential Alzheimer's benefits [27][28] - **Awareness of Lipoprotein(a)**: There is an increasing awareness and understanding of Lipoprotein(a) as a risk factor among patients, which could enhance the market for obicetrapib [30][31] Safety and Efficacy - **Safety Profile**: The safety profile of obicetrapib is emphasized as a significant advantage, especially in a market where patients are increasingly concerned about drug safety [38][39] - **Combination Therapy Potential**: The drug's compatibility with other therapies is highlighted as a key factor for its future success [40] Future Studies and Data - **HORIZON Trial**: The HORIZON trial is expected to read out in the first half of 2026, potentially before the PREVAIL results, which could provide additional insights into the drug's efficacy [33][34] Additional Insights - **Market Dynamics**: The evolving landscape of patient expectations and the increasing focus on personalized medicine are shaping the approach to drug development and marketing strategies [26][27] - **Long-term Vision**: The company is committed to exploring various life cycle management options for obicetrapib, indicating a strategic focus on sustained market presence and adaptability [40]

Merck & Co (NYSE:MRK) FY 2025 Conference December 03, 2025 01:00 PM ET Company ParticipantsChirfi Guindo - CMOEliav Barr - SVP, Head of Global Clinical Development and Chief Medical OfficerConference Call ParticipantsGeoff Meacham - AnalystMary Kate Davis - AnalystGeoff MeachamThe second day of the Citi Global Healthcare Conference. My name is Geoff Meacham. I'm the Senior Biopharma Analyst and Kate Davis. With me as well from my team here on stage. We're thrilled to have Merck in this session. We have Elia ...

Financial Data and Key Metrics Changes - The company anticipates a greater than $5 billion commercial opportunity starting at the end of the decade and escalating into the early 2030s, particularly with the CD388 antiviral treatment for influenza [9] - The company expects modest single-digit growth for Gardasil going forward, despite challenges in the China market, which represents less than 1% of revenue [54] Business Line Data and Key Metrics Changes - CD388 shows 76% efficacy in the chosen dose for phase 3 trials, which is better than existing flu vaccines [6] - Ohtuvayre, acquired from Verona, is expected to significantly scale up the company's respiratory portfolio, with excellent feedback from customers [17][18] - Winrevair in pulmonary arterial hypertension (PAH) is meeting high expectations, with continuous positive feedback from the medical community [28][30] Market Data and Key Metrics Changes - In the U.S., approximately 110 million people are expected to be candidates for CD388 treatment, with about 85 million being high-risk or immunocompromised individuals [7][8] - The company is seeing encouraging uptake in the U.S. for Winrevair, particularly among patients on triple therapy for PAH [31] Company Strategy and Development Direction - The company is focusing on expanding its respiratory portfolio and leveraging its commercial engine to maximize the potential of newly acquired products like Ohtuvayre [17][20] - The strategy includes a strong emphasis on addressing unmet medical needs, particularly in underserved populations such as those with heart failure and pulmonary hypertension [22][24] - The company is also exploring combination therapies in immunology, aiming to broaden the application of its TL1A drug across multiple indications [67][69] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial potential of CD388, highlighting its unique position as an antiviral that provides protection regardless of influenza strain [7][9] - The company is preparing for a challenging influenza season and aims to provide effective protection for high-risk individuals [9] - Management acknowledged the need for ongoing discussions with the FDA regarding the design of phase 3 trials for various products, emphasizing the importance of regulatory guidance [24][26] Other Important Information - The company is committed to driving growth in its vaccine portfolio, with Capvaxive and influenza vaccines expected to perform well in the market [58] - The acquisition of Prometheus is seen as a strategic move to enhance the company's capabilities in treating inflammatory diseases [67] Q&A Session Summary Question: What is the expected market opportunity for CD388? - The company anticipates a greater than $5 billion commercial opportunity starting at the end of the decade, particularly for high-risk populations [9] Question: How is the feedback for Ohtuvayre? - Feedback has been excellent, and the company believes there is a huge opportunity to scale the product [17][18] Question: What are the expectations for Winrevair in PAH? - Winrevair is meeting high expectations, with positive feedback from the medical community and increasing uptake among patients [28][30] Question: How does the company plan to approach the FDA for phase 3 trials? - The company plans to consult with the FDA regarding trial design and aims to ensure that the studies are appropriately sized for critical endpoints [24][26] Question: What is the outlook for Gardasil? - The company expects modest single-digit growth for Gardasil, despite challenges in the China market [54]

Amgen FY Conference Summary Company Overview - **Company**: Amgen (NasdaqGS:AMGN) - **Date of Conference**: December 03, 2025 - **Focus**: Discussion on financial performance, product pipeline, and market dynamics Key Points Financial Performance - Amgen reported a **10% revenue growth** for the first nine months of 2025, with **11% product sales growth** driven by **14% volume growth** [2][3] - **12 products** experienced double-digit growth, and **14 products** are annualizing at over **$1 billion** [3] - The company successfully reduced debt related to the acquisition of Horizon, achieving this a quarter early [4] Growth Drivers - Key growth drivers identified include: - **Repatha**: Grew over **30% year-over-year**, now annualizing at nearly **$3 billion** [6] - **Evenity**: Achieved **30% year-over-year growth**, leading the bone builder segment with over **60% market share** in the U.S. [7] - **Tezspire**: Grew nearly **50% year-over-year**, exceeding **$1 billion** year-to-date [7] - **Rare Disease Portfolio**: Annualizing at almost **$5 billion**, with a **12% year-over-year growth** [8] - **Innovative Oncology Portfolio**: Grew **11% year-over-year**, with Imdeltra becoming a standard of care in small cell lung cancer [9] - **Biosimilars Portfolio**: Grew over **40% year-over-year**, now annualizing at roughly **$3 billion** [10] Pipeline Updates - **Repatha**: Significant cardiovascular outcomes data showing a **25% reduction in MACE** and a **36% reduction in heart attacks** [11] - **MariTide**: Ongoing studies in obesity and type 2 diabetes, with updates expected in the new year [12][63] - **Olpasiran**: In phase 3 development, showing promise in Lp(a) lowering therapy [12] - **Xaluritamig**: Progressing in phase 3 studies for prostate cancer [12] Market Dynamics - The company anticipates competition from oral PCSK9 inhibitors but believes the overall market for LDL-C treatment is underpenetrated, with over **100 million patients** globally not at their LDL-C goal [33][40] - Amgen's access strategies for Repatha include a direct-to-patient program priced at **$239 per month**, with low copays for insured patients [34] Competitive Landscape - The entry of biosimilars for Prolia and Xgeva is expected to impact sales, with a sharper decline anticipated for Xgeva due to consolidated buying power in oncology [20] - Amgen is confident in maintaining market share and growth despite new entrants, citing strong data and physician acceptance [35][39] Future Outlook - Amgen plans to continue investing in innovation, with a research and development budget expected to grow in the mid-20s percentage year-over-year [4] - The company is optimistic about its growth trajectory into 2026, supported by its six identified growth drivers [18][25] Additional Insights - The company is preparing for the launch of Uplizna in generalized myasthenia gravis, with a PDUFA date set for December 14 [18] - The management emphasized the importance of maintaining competitive pricing and access strategies in the evolving market landscape [55] This summary encapsulates the key discussions and insights from the Amgen FY Conference, highlighting the company's strong performance, growth strategies, and future outlook in the biopharmaceutical industry.

Merck & Co (NYSE:MRK) Update / Briefing November 09, 2025 07:01 PM ET Speaker0Welcome to the Merkin Co. Incorporated, Rawlway, New Jersey, USA Investor Event. At this time, all participants are in a listen only mode until the question and answer session of today's conference. This call is being recorded. If you have any objections, you may disconnect at this time.I would now like to turn the call over to Mr. Peter Dannenbaum, Senior Vice President, Investor Relations. Sir, you may begin.Speaker1Thank you, I ...

Core Insights - Amgen's cholesterol drug Repatha has demonstrated a 25% reduction in major cardiovascular events for at-risk patients who have never experienced a heart attack or stroke [1] Group 1 - The addition of Repatha to standard therapy significantly benefits patients at risk for cardiovascular events [1]

Core Insights - Esperion announced acceptance of an oral and a poster presentation at the AHA Scientific Sessions 2025, highlighting ongoing research in cardiovascular health [1][2] Group 1: Presentations - The oral presentation will focus on bempedoic acid monotherapy, LDL cholesterol, and cardiovascular events, based on a secondary analysis of the CLEAR Outcomes trial [2] - A poster presentation will discuss the effects of bempedoic acid on venous thromboembolism, derived from a post-hoc analysis of the CLEAR Outcomes trial [2] Group 2: Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company dedicated to developing new medicines for patients with unmet needs, particularly those at risk for cardiovascular disease [3] - The company has developed the only FDA-approved oral, once-daily, non-statin medications for patients struggling with elevated LDL cholesterol [3] - Esperion's CLEAR Cardiovascular Outcomes Trial involved nearly 14,000 patients, supporting the efficacy of its treatments [3] Group 3: Future Directions - Esperion is advancing its next-generation program focused on developing ATP citrate lyase inhibitors (ACLYi), leveraging new insights for rational drug design [3][4] - The company aims to evolve into a leading global biopharmaceutical entity through commercial execution and international partnerships [4]

Core Viewpoint - The FDA's recent update to fenofibrate drug labeling highlights the lack of cardiovascular benefits and aims to shift clinical practices towards therapies that are clinically proven to reduce cardiovascular events [1][2][3] Company Perspective - Amarin Corporation supports the FDA's decision, emphasizing the need for healthcare practitioners to stop prescribing fibrates for cardiovascular risk reduction, particularly in combination with statins, as this approach is outdated and ineffective [5][6] - The company advocates for the use of FDA-approved therapies like VASCEPA (icosapent ethyl) to reduce cardiovascular risks in patients with elevated triglycerides [6][10] Industry Context - Cardiovascular disease (CVD) is the leading cause of death globally, accounting for over 900,000 deaths annually in the U.S. and nearly 20 million worldwide [2] - Despite evidence from major clinical trials (FIELD, ACCORD Lipid, PROMINENT) showing that fenofibrates do not reduce cardiovascular event risks, over 11 million prescriptions were written in the U.S. in 2023, indicating a significant gap in clinical practice [3][4] - In Europe, fibrates are the third most commonly used lipid management agents, with an estimated two million patients treated with fibrates in Western Europe [4] Clinical Evidence - The FDA's labeling change is based on decades of clinical data demonstrating that fenofibrates do not provide cardiovascular benefits, even when used with statins [3] - The company highlights the importance of aligning treatment decisions with current scientific understanding to improve patient outcomes in cardiovascular health [7]

Core Insights - BridgeBio Pharma's heart-disease drug, Attruby, has shown promising results in reducing the risk of death by nearly 50% in an exploratory study, which could significantly impact treatment approaches for cardiomyopathy [1][2][4] Group 1: Drug Efficacy and Approval - Attruby is approved for treating cardiomyopathy due to transthyretin amyloidosis, with a 49% lower risk of death observed in patients after 30 months of treatment [2][5] - The drug's effects were noticeable within just one month of treatment, suggesting the need for earlier diagnosis and intervention [3][7] - Attruby has been marketed since late 2024, generating $5.9 million in its first quarter, which increased to $71.5 million in subsequent quarters, with a forecast of $94.9 million for the current quarter [5][6] Group 2: Market Potential and Competition - Analysts predict Attruby could become a blockbuster drug by 2027, competing against Pfizer's Vyndaqel, which generated $5.45 billion in sales last year [5][6] - The difference in outcomes between Attruby and placebo was significant, with 53 events prevented per 100 treated patients after 30 months [8] Group 3: Clinical Implications - The cardiologist Dr. Ahmad Masri emphasizes that Attruby could shift the treatment paradigm for TTR-related cardiomyopathy, focusing on preventing serious cardiovascular events [9][10] - Continuous treatment with Attruby is highlighted as crucial for improving patient longevity and quality of life, as recovery from heart failure episodes can be challenging [10]