intismeran autogene
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This Stock Is Already Up 58% This Year. Is It a Buy?
Yahoo Finance· 2026-01-29 02:05
Core Viewpoint - Moderna has faced challenges in maintaining revenue growth from its coronavirus vaccine but has shown a strong start in 2026 with a 58% increase in stock price, raising questions about a potential sustained bull run for the company [1]. Group 1: Recent Developments - Moderna's recent data from a five-year follow-up study on intismeran autogene, in combination with Merck's Keytruda, demonstrated a 49% reduction in disease recurrence or death for advanced melanoma patients compared to Keytruda alone [3]. - Intismeran autogene is currently in a phase 3 study and is being investigated across multiple cancer types, with a total of eight phase 2 or phase 3 studies ongoing [4]. Group 2: Market Position and Opportunities - Moderna has established itself as a leader in mRNA-based therapies and the coronavirus vaccine market, with recent clinical progress and the launch of mRESVIA, a vaccine for respiratory syncytial virus [5]. - The partnership with Merck for intismeran autogene presents a significant commercial opportunity, potentially leading to blockbuster status, despite profit-sharing with Merck [6]. Group 3: Future Prospects - Moderna is expected to make sustained clinical and regulatory progress with several candidates in mid or late-stage clinical trials, which could diversify its lineup of approved products in the next three years [7].
Stock Market Today: S&P 500, Dow Jones Futures Rise As Trump Scales Down EU Tariff Threats—Microsoft, Moderna, Intel In Focus
Benzinga· 2026-01-22 10:19
U.S. stock futures rose on Thursday following Wednesday’s gains. Futures of major benchmark indices were higher.The indices settled higher on Wednesday, gaining more than 1% during the session after President Donald Trump abruptly withdrew his latest round of tariff threats. He stated that planned tariffs on European Union countries will no longer take effect following what he described as a “very productive” meeting with NATO Secretary General Mark Rutte. Meanwhile, the 10-year Treasury bond yielded 4.24%, ...
Intel, Moderna, TMC, Microsoft And Lucid: Why These 5 Stocks Are On Investors' Radars Today - Intel (NASDAQ:INTC)
Benzinga· 2026-01-22 01:23
Market Overview - The stock market experienced a significant rally due to positive developments in international trade, particularly the suspension of planned tariffs on EU countries by President Trump [1] - Major U.S. stock indexes saw notable gains, with the Dow Jones Industrial Average increasing by 1.2% to 49,077.23, the S&P 500 rising by 1.16% to 6,875.62, and the Nasdaq adding 1.18% to 23,224.82 [1] Company Highlights - **Intel Corporation (NASDAQ:INTC)**: - Intel's stock rose by 11.72% to close at $54.25, nearing its 52-week high of $54.41, with an after-hours gain of 1.2% to $54.92 [2] - Anticipation builds for Intel's fourth-quarter earnings report, expected to show earnings per share of 8 cents and revenue of $13.38 billion, following a previous quarter where revenue was $13.65 billion and earnings per share were 23 cents [3] - **Moderna Inc (NASDAQ:MRNA)**: - Moderna shares surged by 15.84% to $49.81, reaching a 52-week high of $50, with an after-hours increase of 4.4% to $52 [4] - Investor enthusiasm is driven by a recent update on a cancer therapy study in collaboration with Merck & Co, which showed significant improvements in recurrence-free survival for melanoma patients [5] - **The Metals Company Inc (NASDAQ:TMC)**: - TMC's stock climbed by 13.31% to $8.17, with an after-hours increase of 9.4% to $8.94 [6] - The company welcomed a new rule from the National Oceanic and Atmospheric Administration that modernizes regulations for deep seabed mining permits, aligning with TMC's strategy for transitioning to commercial production [7] - **Microsoft Corporation (NASDAQ:MSFT)**: - Microsoft's stock fell by 2.29% to $444.11, remaining below its 52-week high of $555.45 [8] - CEO Satya Nadella emphasized the need for artificial intelligence to deliver tangible benefits to maintain public trust, particularly in sectors like healthcare and education [8] - **Lucid Group Inc (NASDAQ:LCID)**: - Lucid's stock jumped by 17.88% to $11.47, with an expansion of its manufacturing partnership in Saudi Arabia enhancing its growth outlook [9] - The collaboration with Rockwell Automation aims to implement advanced manufacturing systems at Lucid's plant, providing real-time visibility and control over production lines [10]
Why Moderna Stock Surged Today
Yahoo Finance· 2026-01-22 00:11
Key Points Moderna's and Merck's partnership could help to advance cancer care. A promising skin cancer trial might have broader implications for other types of tumor treatments. 10 stocks we like better than Moderna › Shares of Moderna (NASDAQ: MRNA) popped on Wednesday after the biotech leader announced positive clinical trial results for its experimental skin cancer vaccine, developed with healthcare giant Merck. By the close of trading, Moderna's stock price was up more than 15%. Image source ...
Moderna Stock on the Move: What Sparked the 13% Jump in the Past Week?
ZACKS· 2026-01-15 14:57
Core Insights - Moderna's shares increased by 13% following the announcement of preliminary sales for 2025 and business outlook for 2026 and beyond [2] - The company reported unaudited total revenues of $1.9 billion for 2025, exceeding the previous guidance range of $1.6-$2.0 billion [3] - Moderna expects operating expenses for 2025 to be between $5.0 billion and $5.2 billion, lower than the prior guidance of $5.2-$5.4 billion [3] Financial Performance - Moderna anticipates ending 2025 with cash and cash equivalents of $8.1 billion, an increase from the previous forecast of $6.5-$7.0 billion [4] - The company projects up to 10% revenue growth for 2026, with targeted operating expenses of approximately $4.9 billion [4] - For 2027, while no revenue guidance was provided, operating expenses are expected to be in the range of $4.2-$4.7 billion [5] Stock Performance - Year-to-date, Moderna's shares have risen by 20%, compared to the industry's growth of 19% [6] Pipeline and Milestones - Moderna has over 30 mRNA-based investigational candidates in various clinical stages, targeting multiple indications including cancer [9] - The company submitted regulatory filings for its seasonal influenza vaccine mRNA-1010 in several regions, with expectations for approval this year but a commercial launch anticipated next year [10] - Data readouts from late-stage studies on RSV and norovirus vaccines are expected before the end of this year [12] Oncology Focus - A key candidate in Moderna's pipeline is intismeran autogene, a personalized cancer therapy developed in collaboration with Merck, with a commercial launch targeted for next year [13] - Moderna is expanding its oncology pipeline, prioritizing the development of mRNA-4359, with a data readout expected before the end of 2026 [14]
Moderna Analyst Day Highlights Pipeline Progress and Business Strategy Updates
Accessnewswire· 2025-11-20 12:00
Core Insights - The company announced a three-year business strategy aiming for up to 10% revenue growth by 2026 [1] - The seasonal vaccine franchise is expected to expand from three to up to six approved products by 2028 [1] - The company targets readouts from nine ongoing Phase 2 and Phase 3 clinical studies in its oncology pipeline, including three Phase 3 programs for intismeran autogene [1] - Expected GAAP operating expenses for 2026 and 2027 are improved by approximately $0.5 billion each year, with a path to targeted cash breakeven in 2028 [1]
Moderna Q3 Earnings Beat, Stock Up on Revised '25 Spending Plans
ZACKS· 2025-11-06 18:01
Core Insights - Moderna reported a loss of $0.51 per share in Q3 2025, which was better than the Zacks Consensus Estimate of a loss of $2.15, compared to an EPS of $0.03 in the same period last year [1][10] - Total revenues for the quarter were $1.02 billion, exceeding the Zacks Consensus Estimate of $860 million, but representing a 45% decline year over year due to lower net product sales [1][10] Revenue Breakdown - Moderna has three marketed vaccines: Spikevax, mNexspike, and mResvia. Product sales fell nearly 47% year over year to $973 million [2] - Sales from COVID-19 vaccines amounted to $971 million, down 46% year over year, attributed to lower vaccination rates and the transition of COVID-19 to a seasonal market [2] - mResvia sales were only $2 million, significantly below the estimated $30 million, and down 80% year over year due to competition from GSK's Arexvy and Pfizer's Abrysvo [3] Operating Costs and Efficiency - SG&A expenses decreased by 5% year over year to $268 million, primarily due to cuts in consulting and external services [5] - R&D expenses were reduced by 30% to $801 million, reflecting a focus on efficiency and prioritization of clinical development [5] Guidance and Outlook - Moderna revised its total revenue guidance for 2025 to a range of $1.6-$2.0 billion, down from $1.5-$2.2 billion [6] - The company also lowered its R&D expense guidance to $3.3-$3.4 billion, from a previous estimate of $3.6-$3.8 billion, while maintaining SG&A and capital expenditure guidance at approximately $1.1 billion and $0.3 billion, respectively [7] Market Reaction - Shares of Moderna rose by 10% in pre-market trading, likely due to the company's cost-cutting measures and improved liquidity outlook, now projected to be between $6.5-$7.0 billion by year-end 2025 [8] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, including a personalized cancer therapy in collaboration with Merck [12][16] - The company discontinued development of mRNA-1647 for CMV prevention after failing to meet primary efficacy endpoints but continues to study it in mid-stage trials for bone marrow transplant patients [13] - Positive results from a phase III study for mRNA-1010, a standalone influenza vaccine, have led to plans for regulatory submissions in early 2026 [14] - The company is also working on mRNA-1083, a combination vaccine for COVID-19 and influenza, and is awaiting further guidance from the FDA [15]
Should You Buy Moderna Stock Ahead of Q3 Earnings Report?
ZACKS· 2025-11-04 14:41
Core Insights - Moderna (MRNA) is expected to report Q3 2025 earnings on November 6, with sales estimated at $860 million and a loss of $2.15 per share, indicating a significant decline from the previous year [1] - The consensus estimate for loss per share has widened from $9.50 to $9.74 over the past month [1] Earnings Performance - Moderna has beaten earnings estimates in the last four quarters, with an average surprise of 37.78%, including a 28.76% surprise in the last reported quarter [2][3] Revenue Expectations - The majority of Q3 revenues are anticipated to come from COVID-19 vaccines, with combined sales estimated at $762 million, reflecting a significant decline due to reduced demand for boosters [5][6] - Minimal sales of the RSV vaccine, mResvia, are expected at $30 million, significantly lower than competitors GSK's Arexvy and Pfizer's Abrysvo [7] Pipeline Developments - Moderna is developing over 40 mRNA-based candidates across various clinical stages, with a focus on updates following the recent setback in the CMV vaccine program [8] - The pivotal Phase III study for mRNA-1647 failed to meet primary efficacy endpoints, leading to its discontinuation, although it continues to be studied in mid-stage trials [9] - Investors are also focused on mRNA-1083, a COVID-19/influenza combination vaccine, which is on track for FDA resubmission [10] - Intismeran autogene, a personalized cancer therapy developed with Merck, is undergoing pivotal studies, and updates on its progress are anticipated [11] Stock Performance and Valuation - Year-to-date, Moderna's shares have decreased by 40%, underperforming the industry and the S&P 500 [13][14] - The stock is trading at a premium valuation, with a price/sales ratio of 3.14 compared to the industry average of 2.33 [16] Investment Outlook - Despite significant declines in revenue, Moderna's cash position of approximately $7.5 billion allows for continued investment in pipeline development [18] - The recent CMV vaccine setback has raised concerns about the company's growth trajectory and reliance on other late-stage assets [19][20] - Plans to launch 10 new marketed products by 2028 targeting a market exceeding $30 billion are now clouded by the CMV failure and underwhelming sales of mResvia [21] - Current premium valuation and downward revisions to earnings estimates suggest caution for investors considering building positions in Moderna stock [22]
Could MRNA's Upcoming Product Launches Reduce COVID Sales Dependency?
ZACKS· 2025-10-02 15:36
Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]
Will the FDA's Nod for Subcutaneous Keytruda Ease Merck's Headwinds?
ZACKS· 2025-09-22 15:26
Core Insights - Merck's Keytruda (pembrolizumab) has received FDA approval for a subcutaneous formulation, Keytruda Qlex, which is expected to launch commercially later this month [1][2] - The subcutaneous version offers improved patient convenience, reducing administration time from at least 30 minutes for the IV version to as little as one minute [2] - The approval is backed by pivotal studies showing that Keytruda Qlex is at least as effective as the IV formulation, with a regulatory filing for the SC version also under review in Europe [3] Group 1: Keytruda Qlex Approval and Market Impact - The approval of Keytruda Qlex is timely as Merck faces the potential loss of exclusivity for Keytruda IV in 2028, which currently accounts for over 48% of the company's revenue [4] - Keytruda IV generated over $15 billion in sales during the first half of 2025, reflecting an 8% year-over-year increase [4] - The new SC version comes with its own patents that extend protection beyond 2028, allowing Merck to manage Keytruda's lifecycle effectively [5] Group 2: Challenges and Competitive Landscape - Merck is experiencing a decline in sales of its second-largest product, Gardasil, which has dropped 48% year over year due to weak demand in China [6] - Competitive pressure for Keytruda may increase from dual PD-1/VEGF inhibitors like Summit Therapeutics' ivonescimab, which has shown potential to outperform Keytruda [9][10] - Merck is actively pursuing innovative combinations and partnerships, including a collaboration with Moderna to develop a personalized mRNA therapeutic cancer vaccine [8] Group 3: Financial Performance and Valuation - Merck's shares have underperformed the industry year to date, with a current price/earnings (P/E) ratio of 8.67, lower than the industry average of 14.88 and its 5-year mean of 12.70 [11][13] - Movements in EPS estimates for 2025 and 2026 have been mixed over the past 60 days, indicating uncertainty in future earnings [15] - Merck currently holds a Zacks Rank 3 (Hold), reflecting a cautious outlook [16]