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Global Markets React to HK Airport Tragedy, FAA Delays, and Amgen’s Cancer Breakthrough
Stock Market News· 2025-10-19 23:08
Incident at Hong Kong International Airport - A cargo plane operated by Turkish carrier Air ACT skidded off the North Runway at Hong Kong International Airport, resulting in one ground staff fatality and another critically injured [2][3][8] - The North Runway is currently closed for investigation and safety inspections, while other runways remain operational [3][8] FAA Flight Delays - The Federal Aviation Administration reported widespread flight delays at major U.S. airports, including Dallas, Chicago, and Newark, due to air traffic control staffing issues exacerbated by a government shutdown [4][8] - The U.S. Travel Association estimates that the ongoing shutdown could cost the economy $1 billion per week [4] Biopharmaceutical Sector Update - Amgen announced positive topline results from its Phase 3 FORTITUDE-101 clinical trial for bemarituzumab, showing a statistically significant improvement in overall survival for patients with advanced gastric cancer [5][8] - Detailed efficacy and safety data from the trial are expected to be presented at an upcoming medical congress [5] Market Sentiment - S&P 500 E-mini futures rose 0.2% and Nasdaq futures were up 0.3% in early Asian trading, following a higher close on Wall Street [6][8] - Positive market sentiment is attributed to President Trump's actions to ease trade tensions with China and the stabilization of regional bank shares [6][8] - The market is pricing in a 100% chance of a 25 basis point rate cut at the upcoming Federal Open Market Committee meeting [6]
Alkermes plc (NASDAQ: ALKS) Investment Analysis
Financial Modeling Prep· 2025-10-18 15:00
Core Insights - Alkermes plc is a biopharmaceutical company focused on innovative medicines for central nervous system disorders and oncology, with a strong product pipeline and strategic initiatives for future growth [1] - The company operates in a competitive industry alongside major players like Biogen and Amgen, but its unique focus and robust financial health differentiate it [1] Recent Performance - Alkermes has shown a notable monthly gain of approximately 8.89%, indicating a strong upward trend [2][6] - However, the stock experienced a slight decline of about 2.36% in the last 10 days, which may present a strategic entry point for investors [2][6] Growth Potential - The stock has significant growth potential, with an estimated increase of approximately 44.75%, suggesting that it is currently undervalued [3][6] - The target price for Alkermes is set at $43.80, aligning with its growth potential and providing a clear upside for investors [3] Financial Health - Alkermes has a perfect Piotroski Score of 9, indicating robust financial health, efficient operations, and potential for future growth [4] - A score of 9 reflects the company's solid financial foundation, making it an attractive investment option [4] Investment Opportunity - Overall, Alkermes presents a compelling investment opportunity due to its recent stock price dip, strong financial metrics, and growth potential [5] - The significant upside associated with the target price of $43.80 makes it an appealing option for investors [5]
US FDA expands use of Amgen, AstraZeneca's drug for sinus infection
Reuters· 2025-10-17 20:08
Core Insights - The U.S. Food and Drug Administration has approved a new drug developed by Amgen and AstraZeneca for treating a type of chronic sinus infection [1] Company Summary - Amgen and AstraZeneca are the drugmakers behind the newly approved treatment for chronic sinus infections [1]
FDA APPROVES TEZSPIRE® FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS
Prnewswire· 2025-10-17 20:00
Core Insights - The FDA has approved TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older, marking it as the first biologic targeting thymic stromal lymphopoietin (TSLP) for this condition [1][3][6] Group 1: Product Approval and Indication - TEZSPIRE is now indicated for both severe asthma and CRSwNP, expanding its therapeutic applications [6][1] - The approval is based on data from the WAYPOINT Phase III trial, which demonstrated significant efficacy in reducing nasal polyp severity and the need for surgery [3][18] Group 2: Disease Impact and Patient Need - CRSwNP affects approximately 320 million people globally, leading to persistent inflammation and symptoms like airflow obstruction and impaired sense of smell [2][4] - Current treatments often fail to provide lasting relief, highlighting the need for new therapeutic options like TEZSPIRE [2][4] Group 3: Clinical Trial Results - In the WAYPOINT trial, TEZSPIRE showed a statistically significant reduction in nasal polyp size and a near-elimination of surgery necessity compared to placebo [3][19] - Key secondary endpoints included improvements in nasal congestion, loss of smell, and overall quality of life [19][3] Group 4: Safety and Tolerability - The safety profile of TEZSPIRE in the WAYPOINT trial was consistent with its established profile in severe asthma, with common adverse events including COVID-19 and upper respiratory infections [4][7] - Hypersensitivity reactions were noted, emphasizing the importance of monitoring during treatment [7][4] Group 5: Future Prospects - Regulatory applications for TEZSPIRE are under review in Europe, China, Japan, and other countries, indicating potential for broader market access [5][1] - The collaboration between Amgen and AstraZeneca continues to evolve, with both companies sharing costs and profits equally for TEZSPIRE [20][1]
Why Amgen (AMGN) Could Beat Earnings Estimates Again
ZACKS· 2025-10-13 17:11
Core Insights - Amgen (AMGN) has a strong history of beating earnings estimates and is well-positioned for continued success in its upcoming quarterly report [1][2] Earnings Performance - Amgen has consistently exceeded earnings expectations, with an average surprise of 16.12% over the last two quarters [2] - In the most recent quarter, Amgen reported earnings of $6.02 per share, surpassing the expected $5.26 by 14.45% [2] - For the previous quarter, the company reported $4.90 per share against an estimate of $4.16, resulting in a surprise of 17.79% [2] Earnings Estimates and Predictions - Recent estimates for Amgen have been revised upward, indicating positive sentiment among analysts [5] - The Zacks Earnings ESP for Amgen is currently +2.44%, suggesting bullish expectations for near-term earnings [8] - The combination of a positive Earnings ESP and a Zacks Rank of 3 (Hold) indicates a high likelihood of another earnings beat [5][8] Statistical Insights - Stocks with a positive Earnings ESP and a Zacks Rank of 3 or better have a nearly 70% chance of producing a positive surprise [6] - The Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate, reflecting the latest analyst revisions [7] Upcoming Events - Amgen's next earnings report is anticipated to be released on November 4, 2025 [8]
Healthy Returns: Amgen joins a growing list of drugmakers selling directly to consumers
CNBC· 2025-10-07 19:31
Core Insights - Drugmakers are increasingly adopting telehealth platforms for direct-to-consumer sales, aligning with the Trump administration's push for lower drug prices [2][3][5] - Amgen has announced a significant price reduction for its cholesterol-lowering drug Repatha, offering it at a cash price 60% lower than its current list price [2] - The Trump administration is promoting a "most favored nation" policy to tie U.S. drug prices to lower prices abroad, urging companies to implement direct-to-consumer sales models [3] Group 1: Industry Trends - The pharmaceutical industry is moving towards direct-to-consumer sales, allowing patients to purchase medications directly from manufacturers at discounted prices [5] - This shift enables drugmakers to bypass intermediaries like pharmacy benefit managers, potentially increasing their revenue [5] Group 2: Government Initiatives - The Trump administration plans to launch a website, TrumpRx.gov, to facilitate direct online purchases of branded drugs at discounts, with Pfizer agreeing to offer discounts averaging 50% and up to 85% on certain drugs [4] - In July, Trump sent letters to 17 drugmakers, urging them to adopt measures to reduce costs for patients, including direct-to-consumer sales [3]
Amgen Unveils New DTC Program, Cuts Cholesterol Drug Price by 60%
ZACKS· 2025-10-07 18:46
Core Insights - Amgen has launched a direct-to-consumer program called AmgenNow, offering significant discounts on its drugs, starting with Repatha, which is priced at $239 per month, representing a nearly 60% discount from its U.S. list price [1][8] - The direct-to-patient price for Repatha is the lowest among G-7 advanced economies, targeting uninsured patients and those on high-deductible health plans [2] - Amgen has partnered with GoodRx to provide Repatha at the same price across 70,000 pharmacies nationwide [3] Financial Performance - Repatha has shown strong sales growth since its launch in 2015, with $696 million in sales during Q2 2025, a 31% increase year over year [4] - The company anticipates that Repatha will evolve into a multi-billion-dollar franchise by 2030 [4] Strategic Initiatives - The launch of AmgenNow aligns with political pressures for pharmaceutical companies to reduce drug prices and improve domestic operations [3][9] - Amgen has made significant investments in U.S. manufacturing, including a $650 million investment to expand its network, a $600 million science and innovation center in California, a $900 million manufacturing expansion in Ohio, and a $1 billion facility in North Carolina [10] Industry Context - Amgen's actions may reflect a broader industry trend, following Pfizer's recent agreement with the Trump administration to align drug prices with those in other developed nations [11][12] - The developments from both Amgen and Pfizer could signal a turning point in easing regulatory and pricing pressures in the pharmaceutical industry [12] Stock Performance - Year-to-date, Amgen's shares have increased by 13%, outperforming the industry average growth of 8% [6]
Amgen to offer Repatha at 60% discount to U.S. consumers
Seeking Alpha· 2025-10-06 15:12
Core Insights - Amgen has launched its cholesterol medication, Repatha, directly to consumers in the U.S. at a reduced cash price [2] - This initiative is part of a broader response from pharmaceutical companies to political pressure [2] Company Actions - The launch of Repatha directly to consumers indicates a shift in Amgen's marketing strategy [2] - The reduced cash price aims to make the medication more accessible to patients [2] Industry Context - The move reflects a trend among pharmaceutical companies to address public and political concerns regarding drug pricing [2] - This action may influence competitive dynamics within the cholesterol medication market [2]
Amgen Lowers Cholesterol-Medication Price After Trump Call for Price Cuts
WSJ· 2025-10-06 15:09
Group 1 - The biotechnology company has launched a new direct-to-patient program called AmgenNow, which initially focuses on its drug Repatha [1]
Amgen to sell cholesterol drug at 60% discount direct to US consumers
Reuters· 2025-10-06 13:03
Core Insights - Amgen has initiated direct-to-consumer sales of its cholesterol medication Repatha in the U.S. at a discounted cash price, responding to political pressure regarding drug pricing [1] Group 1: Company Actions - The launch of Repatha for direct consumer sales marks a strategic move by Amgen to enhance accessibility and affordability of its medication [1] - The discounted cash price indicates Amgen's effort to align with ongoing discussions about drug pricing reform in the U.S. [1] Group 2: Industry Context - Amgen's decision reflects a broader trend among pharmaceutical companies to adapt to political and public pressure regarding high drug prices [1] - The move may influence competitive dynamics within the cholesterol medication market, as other companies may need to respond similarly to maintain market share [1]