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Merck Takes On Amgen, Regeneron, Lowering Stubbornly High Cholesterol By 60%
Investors· 2025-11-08 19:30
Core Insights - Merck's new oral cholesterol-lowering pill, enlicitide, has shown a nearly 60% reduction in LDL cholesterol, positioning it as a potential competitor in the $47 billion cholesterol treatment market by 2033 [2][4]. Group 1: Product Development and Efficacy - Enlicitide works by blocking the PCSK9 protein, which is linked to elevated LDL cholesterol levels and cardiovascular issues [2]. - In a study involving 2,912 patients who could not achieve LDL goals with traditional treatments, enlicitide demonstrated a 55.8% greater reduction in LDL cholesterol compared to placebo, with a placebo-adjusted reduction of 59.7% after excluding an outlier [4]. - Other cardiovascular risk factors, including total cholesterol and markers like ApoB and Lp(a), also decreased, and enlicitide's safety profile was comparable to that of the placebo [5]. Group 2: Market Position and Competition - Merck plans to seek FDA approval for enlicitide in early 2026, aiming to compete with injectable PCSK9 inhibitors like Repatha and Praluent, which have historically faced challenges in market adoption [5]. - Repatha's sales increased by 40% year-over-year to $794 million, while Praluent's sales rose nearly 13% to $215.7 million in the third quarter, indicating a strong market presence for these injectable treatments [6]. Group 3: Patient Accessibility and Usage - Enlicitide is designed to be more accessible, requiring patients to fast for 30 minutes before taking the pill, with 97% of patients able to comply with this requirement [7]. - The ease of use and safety profile of enlicitide could significantly impact public health by providing a viable treatment option for a broader range of patients [8].
AMGEN'S REPATHA® CUTS RISK OF FIRST MAJOR ADVERSE CARDIOVASCULAR EVENTS BY 25% IN LANDMARK PHASE 3 VESALIUS-CV TRIAL
Prnewswire· 2025-11-08 15:15
Core Insights - Amgen's Repatha (evolocumab) has shown significant reductions in major adverse cardiovascular events (MACE) in high-risk adults without prior heart attacks or strokes, marking it as the first PCSK9 inhibitor to achieve this [1][2][6] Clinical Trial Results - The Phase 3 VESALIUS-CV trial involved over 12,000 patients with atherosclerosis or diabetes, demonstrating a 25% relative reduction in the risk of coronary heart disease death, heart attack, or ischemic stroke (3-P MACE) and a 19% reduction in a broader composite including ischemia-driven revascularization (4-P MACE) [1][6] - Repatha reduced the risk of heart attack by 36% and achieved a median LDL-C level of 45 mg/dL compared to 109 mg/dL in the placebo group [1][6] Importance of LDL-C Management - The results emphasize the critical need for intensive LDL-C lowering to reduce cardiovascular risk, particularly in patients with diabetes who are often undertreated [2][3] - The American Diabetes Association highlights the importance of managing LDL-C in primary care settings to address cardiovascular disease, which is a leading cause of mortality among diabetic patients [3] Market and Accessibility - Repatha has been used by over 6.7 million patients globally since its approval in 2015, with recent FDA approvals expanding its use to adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C [5][6] - AmgenNow, a direct-to-patient program, offers Repatha at a monthly price of $239, significantly lower than the previous U.S. list price [5] Commitment to Cardiovascular Innovation - Amgen is dedicated to advancing cardiovascular care through innovative treatments targeting various risk factors associated with cardiovascular disease [6][10] - The company has a robust pipeline of investigational treatments aimed at improving patient outcomes in cardiovascular health [6][10]
Amgen cholesterol drug cuts risk of first cardiac event by 25%
Reuters· 2025-11-08 15:11
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]
Amgen Stock: Buy This Cheap Biotech Leader (NASDAQ:AMGN)
Seeking Alpha· 2025-11-08 05:11
Core Insights - Amgen, Inc. is one of the largest biotechnology companies in America and globally [1] Company Performance - The stock performance of Amgen has been quite volatile over the past 52 weeks [1]
Amgen: Buy This Cheap Biotech Leader
Seeking Alpha· 2025-11-08 05:11
Core Insights - Amgen, Inc. is one of the largest biotechnology companies in America and globally [1] Company Performance - The stock performance of Amgen has been quite volatile over the past 52 weeks [1]
Worldwide Exchange: ETF Flows Week of November 3
CNBC Television· 2025-11-07 12:29
Welcome to CBC. com. I'm Frank Colin, anchor of Worldwide Exchange.We are taking a look at the ETF market, which as of today has $1.13% trillion in net inflows, just a tick below the record set last year. And we are on pace for another record year this year. With that, I want to bring in my guest for today.It's Anaket Ulfra, head of their ETF business. Anakette, thanks for joining us. >> Thanks for having me, Frank.Um, first off, let me talk to you about the fact that ETF inflows are going to hit a record f ...
AstraZeneca Bounds Into A Chase Zone As Cancer Drugs Drive Sales Beat
Investors· 2025-11-06 17:12
Core Insights - AstraZeneca reported earnings of $2.38 per share and $15.19 billion in third-quarter sales, exceeding analyst expectations of $2.29 per share and $14.78 billion in sales [1][2] - Revenue from cancer drugs increased by 19% to $6.64 billion, making up 44% of total sales for the quarter [1] - The company reiterated its guidance, expecting core earnings to rise by a low double-digit percentage and sales to increase by a high single-digit percentage [2] Financial Performance - In the same period last year, AstraZeneca earned $2.08 per share with $13.57 billion in sales [2] - The stock rose by 3.1% to $83.63 in premarket trading following the earnings report [2] Market Position - Analysts project AstraZeneca's earnings for the year to be $9.14 per share with total sales of $58.17 billion [2]
Amgen's Q3 Earnings & Sales Beat, 2025 Outlook Raised, Stock Up
ZACKS· 2025-11-05 17:41
Core Insights - Amgen reported third-quarter 2025 adjusted earnings of $5.64 per share, exceeding the Zacks Consensus Estimate of $5.00 per share, with a year-over-year earnings increase of 1% driven by higher revenues despite increased operating costs and taxes [1] - Total revenues reached $9.6 billion, surpassing the Zacks Consensus Estimate of $8.9 billion, marking a 12% year-over-year increase [1] Revenue Breakdown - Total product revenues increased by 12% year-over-year to $9.17 billion, with volume growth of 14% offset by a 4% negative impact from pricing [2] - Other revenues amounted to $420 million, reflecting a 19.3% year-over-year increase [2] Key Drug Performance - Evenity sales reached $541 million, up 36% year-over-year, exceeding both the Zacks Consensus Estimate of $519 million and the model estimate of $463.9 million [3] - Repatha generated revenues of $794 million, a 40% year-over-year increase, beating the Zacks Consensus Estimate of $720 million and the model estimate of $672.2 million [3] - Prolia revenues were $1.14 billion, up 9% year-over-year, significantly surpassing the Zacks Consensus Estimate of $911 million and the model estimate of $812.8 million [4] - Xgeva delivered revenues of $539 million, flat year-over-year, but exceeded the Zacks Consensus Estimate of $428 million and the model estimate of $408.6 million [5] - Blincyto sales were $392 million, a 20% increase year-over-year, but missed the Zacks Consensus Estimate of $413 million [7] - Otezla sales were $585 million, up 4% year-over-year, beating the Zacks Consensus Estimate of $582 million but missing the model estimate of $648.2 million [8] - Enbrel revenues declined by 30% year-over-year to $580 million, missing the Zacks Consensus Estimate of $645 million but beating the model estimate of $530.4 million [9] - Tezspire recorded sales of $377 million, a 40% year-over-year increase, exceeding both the Zacks Consensus Estimate of $364 million and the model estimate of $270.6 million [10] Cost and Margin Analysis - Adjusted operating margin decreased by 2.5 percentage points to 47.1%, with adjusted operating expenses rising by 18% to $5.25 billion [14] - R&D expenses increased by 31% year-over-year to $1.89 billion, reflecting ongoing investment in the late-stage pipeline [14] Future Outlook - Amgen raised its 2025 revenue and earnings guidance, expecting total revenues between $35.8 billion and $36.6 billion, and adjusted earnings per share in the range of $20.60 to $21.40 [15] - The company anticipates continued growth from key drugs like Repatha, Evenity, Tezspire, and its biosimilar portfolio, although erosion from biosimilars of Prolia and Xgeva may offset some growth [21] Pipeline Developments - Amgen is advancing its obesity drug MariTide, which has shown strong efficacy in clinical studies, with six global phase III studies currently underway [16][17] - Enrollment has been completed in two phase III studies for MariTide, with ongoing studies for cardiovascular disease and heart failure [18]
Amgen: Q3 Earnings Indicate Strong Emphasis On R&D (NASDAQ:AMGN)
Seeking Alpha· 2025-11-05 17:40
Core Viewpoint - The healthcare sector has underperformed compared to the broader market in recent years, yet Amgen Inc. (AMGN) presents attractive growth opportunities for long-term investors [1] Group 1: Company Analysis - Amgen Inc. is highlighted as a company with strong growth prospects despite the overall sector's lagging performance [1] - The investment strategy includes a mix of classic dividend growth stocks, Business Development Companies, REITs, and Closed End Funds to enhance investment income while achieving total returns comparable to traditional index funds [1] Group 2: Investment Strategy - A hybrid investment approach combining growth and income is suggested as an effective method to achieve returns on par with the S&P [1]
Amgen: Q3 Earnings Indicate Strong Emphasis On R&D
Seeking Alpha· 2025-11-05 17:40
Although the healthcare sector has lagged behind the rest of the market over the last few years, I believe that Amgen Inc. ( AMGN ) still offers attractive growth prospects to long-term investors. TheFinancial analyst by day and a seasoned investor by passion, I've been involved in the world of investing for over 15 years and honed my skills in analyzing lucrative opportunities within the market.I specialize in uncovering high quality dividend stocks and other assets that offer potential for long term-growt ...