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AMGEN'S LANDMARK PHASE 3 REPATHA DATA TO BE PRESENTED AS LATE BREAKER AT THE AMERICAN HEART ASSOCIATION SCIENTIFIC SESSIONS 2025
Prnewswire· 2025-10-31 13:00
Core Insights - Amgen announced that the Phase 3 VESALIUS-CV clinical trial of Repatha met its dual primary endpoints, demonstrating significant reduction in major adverse cardiovascular events (MACE) in high-risk patients without prior heart attack or stroke [2][3] - The results will be presented at the American Heart Association Scientific Sessions in November 2025, highlighting Repatha's position as a leading LDL-C lowering therapy [1][2] Group 1: Clinical Trial Results - The VESALIUS-CV trial is the first to show that Repatha significantly reduces the risk of MACE in individuals without a history of heart attack or stroke [2] - The trial's findings emphasize the importance of early intervention and maintaining low LDL-C levels to prevent cardiovascular events [2][3] Group 2: Real-World Evidence - Data from the VESALIUS-REAL global observational study, covering over 1.1 million patients across 11 countries, will provide insights into lipid management and MACE incidence in high-risk populations [3] - The REPATHA-CE trial, the largest real-world study of patients with established atherosclerotic cardiovascular disease (ASCVD), demonstrates Repatha's effectiveness in reducing MACE in clinical practice [4] Group 3: Company Commitment - Amgen is committed to advancing cardiovascular care through innovative treatments and extensive research, as evidenced by its ongoing clinical trials and real-world studies [2][7] - The company aims to address multiple interrelated risk factors associated with cardiovascular disease, reflecting a comprehensive approach to prevention and care [7]
Marjorie Taylor Greene Buys Netflix Stock After Downbeat Q3 Earnings, Expands Big Tech Bet - Netflix (NASDAQ:NFLX)
Benzinga· 2025-10-31 07:08
Core Insights - Rep. Marjorie Taylor Greene purchased shares of Netflix Inc. on October 24, following a significant drop in the stock price after a disappointing third-quarter earnings report [1][2] Investment Activity - The purchase of Netflix was valued between $1,001 and $15,000 and was part of 14 new investments disclosed in a Periodic Transaction Report filed on October 28 [2][5] - Greene's investment strategy appears to align with a "buy the dip" approach, as she made the purchase shortly after the stock's decline [2] - This transaction adds to her existing position in Netflix, which she had previously purchased in June and May [3] Broader Investment Strategy - Greene's investment in Netflix is part of a larger trend of increasing her holdings in the technology sector, including purchases in Microsoft Corp., Amazon.com Inc., and MercadoLibre Inc. [3] - She has also continued to build her position in the iShares Bitcoin Trust ETF, indicating a consistent strategy of adding to existing holdings [4] - Other notable purchases in October included investments in finance (Berkshire Hathaway Inc., Blackstone Inc.), healthcare (Amgen Inc., Cardinal Health Inc.), and energy (Chevron Corp.) [5][6] Summary of Transactions - A total of 14 transactions were reported, all of which were purchases valued between $1,001 and $15,000, with no sales reported [5][6]
Amgen (AMGN) Q3 Earnings Preview: What You Should Know Beyond the Headline Estimates
ZACKS· 2025-10-30 14:16
Core Insights - Analysts project Amgen (AMGN) will report quarterly earnings of $5.00 per share, reflecting a 10.4% decline year over year, with revenues expected to reach $8.94 billion, a 5.2% increase from the same quarter last year [1] Earnings Estimates - The consensus EPS estimate has been adjusted downward by 0.9% over the past 30 days, indicating a reassessment by covering analysts [1][2] - Revisions to earnings estimates are significant indicators for predicting investor actions regarding the stock [2] Revenue Projections - Analysts estimate 'Revenue- Other revenues' at $373.34 million, indicating a year-over-year change of +6.1% [4] - 'Revenue- Product sales' is projected to be $8.55 billion, reflecting a +4.8% change from the prior-year quarter [4] Product Sales Forecasts - 'Product Sales- BLINCYTO- Total' is expected to reach $412.70 million, showing a +26.2% change year over year [4] - 'Product Sales- Otezla- Total' is forecasted at $582.08 million, indicating a +3.2% change [5] - 'Product Sales- Neulasta- U.S.' is expected to be $60.90 million, reflecting a -27.5% change [5] - 'Product Sales- Repatha- U.S.' is projected at $367.86 million, indicating a +30.9% change [6] - 'Product Sales- BLINCYTO- U.S.' is expected to reach $298.45 million, reflecting a +25.9% change [7] Market Performance - Amgen shares have shown a return of -2.3% over the past month, compared to a +3.6% change in the Zacks S&P 500 composite [8]
U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo)
The Manila Times· 2025-10-30 07:53
Core Viewpoint - Celltrion, Inc. has received FDA designation for its biosimilars STOBOCLO® and OSENVELT® as interchangeable with the reference products PROLIA® and XGEVA®, respectively, for all approved indications, enhancing patient access and treatment options in the U.S. market [1][5]. Group 1: Product Information - STOBOCLO® (denosumab-bmwo) is indicated for treating postmenopausal women with osteoporosis at high risk for fracture, increasing bone mass in men with osteoporosis, and treating glucocorticoid-induced osteoporosis [4][6]. - OSENVELT® (denosumab-bmwo) is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases, treating unresectable giant cell tumor of bone, and managing hypercalcemia of malignancy [17][21]. Group 2: Regulatory Designation - The FDA's interchangeability designation allows STOBOCLO and OSENVELT to be substituted for their reference products at pharmacies without consulting the prescriber, subject to state laws [3][5]. - The designations were based on comprehensive clinical data, including Phase III trial results demonstrating efficacy, safety, and pharmacokinetics in postmenopausal women with osteoporosis [3][5]. Group 3: Market Impact - The interchangeability designations are expected to reinforce confidence among healthcare providers, facilitating a smoother transition to these biosimilars and potentially leading to cost savings for patients and the U.S. healthcare system [3][5]. - STOBOCLO and OSENVELT were introduced to the U.S. market in July 2025, with STOBOCLO available in a 60 mg/mL injection and OSENVELT in a 120 mg/1.7 mL (70 mg/mL) injection [3][4].
AMGEN ANNOUNCES WEBCAST OF 2025 THIRD QUARTER FINANCIAL RESULTS
Prnewswire· 2025-10-29 20:01
Core Viewpoint - Amgen is set to report its third quarter 2025 financial results on November 4, 2025, followed by a conference call with senior management to discuss the results and engage with the investment community [1]. Financial Results Announcement - The financial results will be announced after the close of U.S. financial markets on November 4, 2025 [1]. - A conference call will take place at 4:30 p.m. ET, featuring Robert A. Bradway, chairman and CEO, along with other senior management members [1]. Conference Call Details - The conference call will be broadcast live over the internet, accessible to media, investors, and the general public [2]. - The webcast will be archived and available for replay for at least 90 days post-event [3]. Company Overview - Amgen is a biotechnology company focused on discovering, developing, manufacturing, and delivering innovative medicines for serious diseases [4]. - The company has a strong pipeline aimed at treating various conditions, including cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases [4]. Recognition and Market Position - In 2024, Amgen was recognized as one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes [5]. - Amgen is part of the Dow Jones Industrial Average and the Nasdaq-100 Index, highlighting its significant market presence [5].
Amgen's Q3 Earnings in the Cards: Here's What to Expect
ZACKS· 2025-10-29 16:31
Core Insights - Amgen (AMGN) is set to report its third-quarter 2025 results on November 4, with earnings expected to be $5.00 per share and sales at $8.94 billion, reflecting a 14.5% earnings surprise in the last quarter [1][9] Sales Performance - Strong volume growth from products like Evenity, Repatha, and Blincyto is anticipated to drive sales, with consensus estimates for these products at $519 million, $720 million, and $413 million respectively [2] - The company's own estimates for Evenity, Repatha, and Blincyto are slightly lower at $463.9 million, $672.2 million, and $395.5 million respectively [3] - Sales of RANKL antibodies, Prolia, and Xgeva are expected to decline significantly due to patent expirations and the launch of three biosimilars in the U.S. market [4] New Product Contributions - Newer drugs such as Imdelltra, Tavneos, and Tezspire are projected to contribute positively to top-line growth, with consensus estimates for Tezspire and Tavneos at $364 million and $119 million respectively [5] - The company's estimates for Tezspire and Tavneos are $270.6 million and $120.7 million respectively [5] Competitive Pressures - Kyprolis is expected to face continued competitive pressure, with consensus sales estimates at $374 million and the company's estimate at $372.6 million [6] - Enbrel sales are likely to decline due to price reductions, while Otezla is expected to benefit from volume growth, with consensus estimates for Otezla at $582 million and Enbrel at $645 million [6] Recent Acquisitions - Sales of rare disease drugs Tepezza, Krystexxa, and Uplizna, acquired from Horizon in October 2023, showed improvement in the second quarter and are expected to continue this trend [7] Biosimilar Market Impact - Lower revenues from oncology biosimilars and legacy products are anticipated, although newer biosimilars like Wezlana and Pavblu may contribute to sales growth [8][10] Financial Outlook - Higher R&D costs are likely to impact operating margins negatively in the third quarter [11] - Amgen's earnings surprise history shows a strong performance, with an average surprise of 11.75% over the last four quarters [12] Earnings Prediction - The current Earnings ESP for Amgen is -1.25%, indicating uncertainty regarding an earnings beat this quarter [14]
Agilent Names Adam S. Elinoff as Chief Financial Officer
Businesswire· 2025-10-27 20:15
Core Insights - Agilent Technologies Inc. has appointed Adam S. Elinoff as the new Chief Financial Officer, effective November 17 [1] - Elinoff brings over 20 years of financial experience, including roles in corporate finance, investor relations, and business transformation [2] - He previously worked at Amgen for 19 years, where he held various finance and strategy leadership positions, most recently as Vice President of Finance and Treasurer [3] Company Leadership - Agilent's President and CEO, Padraig McDonnell, expressed enthusiasm about Elinoff's appointment, highlighting his expertise in strategic planning and M&A as crucial for Agilent's growth [4] - Elinoff will work closely with the executive team to enhance Agilent's financial operations and innovation [4] - Rodney Gonsalves, the interim CFO, will continue as corporate controller and principal accounting officer [4] Financial Background - At Amgen, Elinoff managed a $6 billion P&L and oversaw finance and analytics across 67 markets, achieving significant revenue and profitability growth [3] - His career includes leadership roles in corporate financial planning, global business services, and R&D finance [3] Educational Background - Elinoff holds a Bachelor of Arts in Economics from Hamilton College and an MBA from Arizona State University [5] Company Overview - Agilent Technologies is a global leader in analytical and clinical laboratory technologies, generating $6.51 billion in revenue for fiscal year 2024 and employing approximately 18,000 people [8]
Halper Sadeh LLC Encourages Amgen Inc. Shareholders to Contact the Firm to Discuss Their Rights
Businesswire· 2025-10-22 23:22
Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of Amgen Inc. [1] Group 1 - The investigation pertains to whether Amgen's leadership acted in the best interests of shareholders [1] - Shareholders who acquired Amgen stock on or before July 29, 2020, may seek various forms of corporate governance reforms and financial relief [1]
CytomX Therapeutics Appoints Rachael Lester as Chief Business Officer
Globenewswire· 2025-10-20 20:05
Core Insights - CytomX Therapeutics has appointed Rachael Lester as Senior Vice President and Chief Business Officer to enhance its strategic long-term value creation and partnering strategy [1][2] - The company is well-positioned to advance its clinical assets, particularly CX-2051 and CX-801, which target high unmet medical needs in cancer treatment [2][4] Company Overview - CytomX Therapeutics is a clinical-stage biopharmaceutical company focused on developing conditionally activated, masked biologics aimed at localized tumor treatment [4] - The company's PROBODY therapeutic platform enables the creation of safer and more effective cancer therapies, with a pipeline that includes antibody-drug conjugates, T-cell engagers, and immune modulators [4] Leadership Experience - Rachael Lester brings over 20 years of experience in corporate strategy and business development within the biopharmaceutical industry [3] - Prior to joining CytomX, she held significant roles at Replicate Bioscience and Harpoon Therapeutics, where she was instrumental in securing financing and establishing major partnerships [3] Clinical Pipeline - CytomX's lead clinical assets include CX-2051, a masked ADC targeting EpCAM, and CX-801, a masked interferon alpha-2b PROBODY cytokine, both of which have broad potential across various cancer types [4] - CX-2051 is designed to treat multiple EpCAM-expressing epithelial cancers, including colorectal cancer, while CX-801 has applications in both immuno-oncology sensitive and insensitive tumors [4] Strategic Collaborations - The company has established strategic partnerships with leading oncology firms such as Amgen, Astellas, Bristol Myers Squibb, Regeneron, and Moderna to enhance its research and development efforts [4]
3 Dividend-Paying ETFs to Double Down On Even if the S&P 500 Sells Off in October
Yahoo Finance· 2025-10-20 12:21
Core Insights - The article emphasizes the benefits of investing in dividend-focused ETFs, particularly for generating income and potential price appreciation over time [1][5]. Dividend Income and Growth - Dividend-paying stocks can provide significant annual income; for instance, a portfolio of $400,000 with a 3% yield can generate approximately $12,000 annually, which is expected to grow over time [2]. - Healthy and growing dividend stocks typically increase their payouts, helping investors keep pace with inflation [3]. Investment Strategy - Investing in dividend-paying stocks can be a strategic move, especially during market downturns, as these stocks tend to provide regular income regardless of market conditions [4]. - The article suggests that market timing is ineffective, and investors should consider adding to their positions even during uncertain market periods [5]. Recommended ETFs - Three recommended ETFs include: 1. **iShares Preferred and Income Securities ETF (PFF)**: Offers a high yield of 6.46% but with slower growth potential [6][8]. 2. **Schwab U.S. Dividend Equity ETF (SCHD)**: Tracks high-quality companies with a yield of 3.79% and a strong performance record [6][10]. 3. **Vanguard Dividend Appreciation ETF (VIG)**: Focuses on companies with a history of increasing dividends, yielding 1.64% [6][11]. Performance Metrics - The article provides performance metrics for the recommended ETFs, highlighting their average annual returns over 5 and 10 years, indicating a trade-off between yield and growth potential [6][7].