Category: 3. Business

  • A Fresh Look at Kellanova (K) Valuation as Investors Weigh Recent Momentum and Growth Potential

    A Fresh Look at Kellanova (K) Valuation as Investors Weigh Recent Momentum and Growth Potential

    Kellanova (K) stock has been catching some attention lately, as investors look beyond day-to-day moves to assess its strategic direction and broader performance. With steady revenue and net income growth reported, the company is maintaining momentum in a competitive market.

    See our latest analysis for Kellanova.

    Kellanova’s share price has climbed 5.2% in the past three months, reflecting renewed optimism as the company continues to post steady results amid industry competition. With a 5.8% total shareholder return over the past year and a cumulative five-year total return of 68.3%, momentum appears to be building as investors focus on its long-term story.

    If you’re on the lookout for what else might offer solid upside, now could be a great time to broaden your search and discover fast growing stocks with high insider ownership

    With the stock posting consistent gains yet trading right around analyst targets, the big question now is whether Kellanova is undervalued with room to run, or if the market is already pricing in its future growth.

    With Kellanova’s share price closing at $83.64 and the widely followed narrative fair value target set at $83.39, investors are seeing a close alignment between current market sentiment and projected earnings potential. This minimal difference signals that the latest company outlook is largely priced in, but it is worth examining what is driving this consensus.

    The company’s focus on differentiated geographic footprint, particularly in emerging markets, should lead to sequential volume improvement and organic growth in net sales, positively impacting revenue. A heavy calendar of innovation, including product launches in snacks and away-from-home channels, is projected to increase net sales contribution from innovation, driving revenue growth.

    Read the complete narrative.

    Curious what kind of earnings growth and profit margins are backing this fair value? The narrative relies on a blueprint of aggressive innovation, bold new launches, and ambitious performance metrics. Want to see which numbers the valuation hinges on? Uncover the details that the market is watching closely.

    Result: Fair Value of $83.39 (ABOUT RIGHT)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, shifts in consumer spending in Europe or innovation setbacks in major product launches could challenge Kellanova’s steady growth outlook.

    Find out about the key risks to this Kellanova narrative.

    While the consensus price target suggests Kellanova is fairly valued, our DCF model estimates the company’s fair value at $95.81. This is 12.7% above the current share price. This method implies the market might be overlooking potential upside. Could the real value be higher than expected?

    Look into how the SWS DCF model arrives at its fair value.

    K Discounted Cash Flow as at Nov 2025

    Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Kellanova for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 920 undervalued stocks based on their cash flows. If you save a screener we even alert you when new companies match – so you never miss a potential opportunity.

    If you think the story could unfold differently or want to review the numbers firsthand, you can craft your own perspective in just minutes. Do it your way

    A great starting point for your Kellanova research is our analysis highlighting 3 key rewards and 2 important warning signs that could impact your investment decision.

    Don’t let opportunity slip away. Expand your horizons now and take advantage of exclusive stock ideas the market hasn’t fully noticed yet with the Simply Wall Street Screener.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include K.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • How Recent Developments Are Shaping the Investment Story for Privia Health

    How Recent Developments Are Shaping the Investment Story for Privia Health

    Privia Health Group has seen its Fair Value Estimate increase slightly to $31.11 from $30.89. This signals modest analyst optimism based on recent company updates. Revenue growth projections have also edged higher, now expected to reach 12.04%. Stay tuned to discover how investors and followers can monitor future shifts in Privia Health Group’s evolving story.

    Analyst Price Targets don’t always capture the full story. Head over to our Company Report to find new ways to value Privia Health Group.

    🐂 Bullish Takeaways

    • At this time, there is limited specific analyst commentary available to support strongly bullish sentiment for Privia Health Group.

    • Analysts are generally positive on factors such as the company’s solid execution, consistent revenue growth, and ongoing transparency in reporting.

    • Near-term growth momentum continues to be viewed as a favorable aspect, and there is ongoing attention to cost control and scalability.

    🐻 Bearish Takeaways

    • Some cautious perspectives remain around valuation concerns and whether the recent upside is already priced in.

    • Mixed analyst sentiment includes reservations about near-term risks that could impact future performance. However, no substantial price target changes from major firms have been highlighted in recent commentary.

    Overall, while the coverage is modest at present, analysts appear to be weighing Privia Health Group’s solid growth against its current valuation and market expectations. This leaves room for both optimism and caution as the story continues to unfold.

    Do your thoughts align with the Bull or Bear Analysts? Perhaps you think there’s more to the story. Head to the Simply Wall St Community to discover more perspectives or begin writing your own Narrative!

    NasdaqGS:PRVA Community Fair Values as at Nov 2025
    • Privia Health Group, Inc. has raised its full-year 2025 earnings guidance and now expects GAAP revenue to be between $2,050 million and $2,100 million. This is an increase from the previous estimate of $1,800 million to $1,900 million.

    • The latest financial update reflects increased confidence in the company’s ability to deliver robust revenue growth in the coming year.

    • This updated guidance highlights the company’s recent operational and strategic momentum, providing investors with improved visibility into Privia Health Group’s future prospects.

    • The Fair Value Estimate has risen slightly to $31.11 from $30.89, reflecting modest analyst optimism.

    • The Discount Rate remains effectively unchanged at 6.96%.

    • Revenue Growth has improved marginally and is now projected at 12.04%, up from 11.99%.

    • The Net Profit Margin has fallen significantly to 2.84%, compared to the previous estimate of 3.48%.

    • The Future P/E Ratio has increased notably to 60.57x from 50.02x, indicating higher expected valuations relative to earnings projections.

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  • Airlines With A Heart – Commercial Aviation

    Luxair, the flag carrier of Luxembourg, has welcomed the E195-E2 into its fleet – marking the start of an exciting new chapter as the airline pursues its ambition to modernize and grow sustainably.

    Connecting Luxembourg with Europe and beyond, Luxair ensures mobility and accessibility at the heart of Europe. Deeply rooted in local communities, the airline is now set to elevate its customers’ travel experience. Passengers can look forward to spacious 2+2 seating, a generous pitch, a quiet cabin, as well as advanced in-flight entertainment.


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  • With EPS Growth And More, Xylem (NYSE:XYL) Makes An Interesting Case

    With EPS Growth And More, Xylem (NYSE:XYL) Makes An Interesting Case

    Investors are often guided by the idea of discovering ‘the next big thing’, even if that means buying ‘story stocks’ without any revenue, let alone profit. But as Peter Lynch said in One Up On Wall Street, ‘Long shots almost never pay off.’ A loss-making company is yet to prove itself with profit, and eventually the inflow of external capital may dry up.

    If this kind of company isn’t your style, you like companies that generate revenue, and even earn profits, then you may well be interested in Xylem (NYSE:XYL). Now this is not to say that the company presents the best investment opportunity around, but profitability is a key component to success in business.

    This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality.

    The market is a voting machine in the short term, but a weighing machine in the long term, so you’d expect share price to follow earnings per share (EPS) outcomes eventually. Therefore, there are plenty of investors who like to buy shares in companies that are growing EPS. It certainly is nice to see that Xylem has managed to grow EPS by 30% per year over three years. As a general rule, we’d say that if a company can keep up that sort of growth, shareholders will be beaming.

    One way to double-check a company’s growth is to look at how its revenue, and earnings before interest and tax (EBIT) margins are changing. While we note Xylem achieved similar EBIT margins to last year, revenue grew by a solid 5.6% to US$8.9b. That’s encouraging news for the company!

    You can take a look at the company’s revenue and earnings growth trend, in the chart below. Click on the chart to see the exact numbers.

    NYSE:XYL Earnings and Revenue History November 29th 2025

    View our latest analysis for Xylem

    The trick, as an investor, is to find companies that are going to perform well in the future, not just in the past. While crystal balls don’t exist, you can check our visualization of consensus analyst forecasts for Xylem’s future EPS 100% free.

    We would not expect to see insiders owning a large percentage of a US$34b company like Xylem. But we are reassured by the fact they have invested in the company. We note that their impressive stake in the company is worth US$194m. This comes in at 0.6% of shares in the company, which is a fair amount of a business of this size. This still shows shareholders there is a degree of alignment between management and themselves.

    While it’s always good to see some strong conviction in the company from insiders through heavy investment, it’s also important for shareholders to ask if management compensation policies are reasonable. Well, based on the CEO pay, you’d argue that they are indeed. Our analysis has discovered that the median total compensation for the CEOs of companies like Xylem, with market caps over US$8.0b, is about US$13m.

    The Xylem CEO received US$11m in compensation for the year ending December 2024. That is actually below the median for CEO’s of similarly sized companies. CEO compensation is hardly the most important aspect of a company to consider, but when it’s reasonable, that gives a little more confidence that leadership are looking out for shareholder interests. It can also be a sign of good governance, more generally.

    If you believe that share price follows earnings per share you should definitely be delving further into Xylem’s strong EPS growth. If you still have your doubts, remember too that company insiders have a considerable investment aligning themselves with the shareholders and CEO pay is quite modest compared to similarly sized companiess. Everyone has their own preferences when it comes to investing but it definitely makes Xylem look rather interesting indeed. It is worth noting though that we have found 1 warning sign for Xylem that you need to take into consideration.

    Although Xylem certainly looks good, it may appeal to more investors if insiders were buying up shares. If you like to see companies with more skin in the game, then check out this handpicked selection of companies that not only boast of strong growth but have strong insider backing.

    Please note the insider transactions discussed in this article refer to reportable transactions in the relevant jurisdiction.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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  • December will begin with investors owning little stock. Is a year-end rally at play?

    December will begin with investors owning little stock. Is a year-end rally at play?

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  • Examining Eni’s Valuation After a 19.8% Share Price Surge in 2025

    Examining Eni’s Valuation After a 19.8% Share Price Surge in 2025

    • Wondering if Eni’s recent run puts the stock at a discount or if the best value days are already behind it? You’re not alone, as investors everywhere are asking the same question right now.

    • Eni’s share price has climbed 19.8% so far this year and 29.1% over the past 12 months, indicating renewed optimism and possible growth ahead.

    • Much of this excitement has been fueled by recent positive developments in the energy sector, including moves toward cleaner production and new international projects. News highlighting Eni’s investment in low-carbon initiatives and overseas exploration has caught investors’ attention and contributed to the stock’s upward momentum.

    • On the valuation front, Eni scores a 3 out of 6 based on our undervaluation checks. Next, we will explore the methods behind that score and provide insights to help better understand Eni’s real value.

    Eni delivered 29.1% returns over the last year. See how this stacks up to the rest of the Oil and Gas industry.

    The Discounted Cash Flow (DCF) model estimates a company’s value by projecting its future cash flows and discounting them back to today’s value. This approach helps investors gauge the present worth of all expected future cash the business will generate, using current financial data and reasonable growth assumptions.

    For Eni, the most recent Free Cash Flow stands at approximately €4.40 billion. According to analyst consensus and Simply Wall St extrapolations, these cash flows are forecast to grow moderately, with projections reaching roughly €5.19 billion by 2028 and continuing upwards through 2035. Early estimates rely on analyst forecasts, while later years use logical estimates based on prevailing growth trends in the sector.

    Using these inputs, the DCF analysis values Eni at an intrinsic fair value of €22.02 per share. This suggests that the current market price is about 26.7 percent below what the company’s future cash flows are worth today, indicating the stock is significantly undervalued according to this model. For investors seeking growth and value, this assessment may indicate a promising entry point.

    Result: UNDERVALUED

    Our Discounted Cash Flow (DCF) analysis suggests Eni is undervalued by 26.7%. Track this in your watchlist or portfolio, or discover 920 more undervalued stocks based on cash flows.

    ENI Discounted Cash Flow as at Nov 2025

    Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for Eni.

    The Price-to-Earnings (PE) ratio is a well-known method used to value profitable companies like Eni, as it connects the market price to the company’s actual earnings. This metric is especially relevant for established businesses with positive earnings, offering a straightforward way to compare value across the sector.

    It’s important to remember that what counts as a “normal” or “fair” PE ratio can change depending on growth prospects and perceived risk. Companies expected to grow rapidly or those considered safer investments typically command higher PE ratios, while riskier or slower-growing firms usually see lower multiples.

    Currently, Eni trades at a PE ratio of 18.7x, which is higher than both the industry average of 13.3x and the peer group average of 13.1x. At first glance, this might suggest Eni is more expensive than its rivals. However, simply comparing these averages does not tell the whole story. This is where Simply Wall St’s “Fair Ratio” comes in. The Fair Ratio, calculated at 21.5x for Eni, incorporates not just earnings but also factors like Eni’s growth outlook, profitability, risk profile, industry position, and its size in the market.

    The Fair Ratio is a more holistic metric than industry or peer comparisons because it is tuned to Eni’s specific fundamentals, rather than being based on broader or less relevant companies. In this case, Eni’s actual PE ratio is about 2.8x below its Fair Ratio, indicating that, on this measure, the stock could be considered undervalued.

    Result: UNDERVALUED

    BIT:ENI PE Ratio as at Nov 2025
    BIT:ENI PE Ratio as at Nov 2025

    PE ratios tell one story, but what if the real opportunity lies elsewhere? Discover 1443 companies where insiders are betting big on explosive growth.

    Earlier we mentioned that there is an even better way to understand valuation, so let’s introduce you to Narratives. A Narrative is your own story about a company that connects what you believe about its business, industry changes, and trends with the actual numbers, such as fair value, future revenue, earnings, and profit margins.

    Rather than simply relying on historic data or a single metric, Narratives let you link what is happening in the real world to a financial forecast and, ultimately, to what you believe is a fair price for the stock. This approach is accessible and easy to use for investors of all experience levels on Simply Wall St, right from the Community page used by millions.

    Narratives empower you to decide when to buy or sell, making it simple to see at a glance how your fair value compares to the current price. Because they update automatically with new information, such as news, earnings reports, or industry developments, your view is always relevant and up to date.

    For example, when it comes to Eni, some investors are optimistic and see a fair value as high as €17.5, while others, more cautious, estimate just €13.5. This illustrates how Narratives capture the range of real investor perspectives and make stock decisions more intuitive and personal.

    Do you think there’s more to the story for Eni? Head over to our Community to see what others are saying!

    BIT:ENI Community Fair Values as at Nov 2025
    BIT:ENI Community Fair Values as at Nov 2025

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include ENI.MI.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • What Catalysts Could Shift the Story for TI Amid Margin Pressures and Tariff Uncertainty

    What Catalysts Could Shift the Story for TI Amid Margin Pressures and Tariff Uncertainty

    Texas Instruments’ price target remains steady, reflecting confidence in the company’s long-term fundamentals despite shifting economic conditions. Analyst sentiment incorporates a mix of optimism around disciplined inventory management as well as cautiousness due to margin pressures and muted growth visibility. Stay tuned to see how you can monitor ongoing updates to the Texas Instruments investment narrative.

    Analyst Price Targets don’t always capture the full story. Head over to our Company Report to find new ways to value Texas Instruments.

    Recent analyst commentary on Texas Instruments reflects a diverse range of perspectives on the company’s current positioning and outlook. Below, we synthesize the main themes from the latest research updates.

    🐂 Bullish Takeaways

    • Rosenblatt maintains a Buy rating for Texas Instruments, noting disciplined management even in the face of operational headwinds. Despite lowering the price target to $200 from $245, the firm points to inline results and confident handling of inventory and manufacturing assets as strengths.

    • JPMorgan keeps an Overweight rating and adjusted its price target to $210 from $225, citing solid September quarter revenue and a continued belief in Texas Instruments’ long-term positioning. The “conservative” forward outlook is seen as a prudent response to macro uncertainty rather than a signal of execution issues.

    • Wolfe Research remains constructive, reiterating an Outperform rating with a $230 price target. The firm recognizes that recoveries are underway in most major end markets, with the exception of automotive, and sees prudent inventory and wafer start management as indicative of operational discipline.

    • Morgan Stanley suggests potential upside if low customer inventories drive replenishment, even as it takes a more reserved view overall. The firm acknowledges the flat recovery slope but points to eventual positive momentum as order trends improve.

    🐻 Bearish Takeaways

    • Mizuho downgraded Texas Instruments to Underperform, dropping the price target significantly to $150 from $200. The analyst raises concerns about the lack of near-term catalysts, premium valuation, slowing auto sales, ongoing competition in China, and tariff headwinds. Additionally, the company’s smaller footprint in high-growth segments like AI data centers is seen as a limitation.

    • Truist lowered its price target to $175 from $196 while maintaining a Hold rating, citing mixed quarterly results and fading margins. The analyst notes that while inventory levels have normalized, demand has not rebounded, and customers are not actively restocking, which limits prospects for near-term recovery.

    • Rosenblatt, while positive overall, highlights that margin pressures linked to reduced fab utilization are likely to persist in the short term as management seeks to balance inventory levels.

    • Morgan Stanley keeps an Underweight rating with a reduced target of $192 from $197, expressing caution over the underwhelming outlook for the September quarter and the challenging recovery trajectory presently facing the analog semiconductor sector, of which Texas Instruments is a key part.

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  • Why Analysts See Lundin Gold’s Story Shifting With Higher Price Targets and Gold Forecasts

    Why Analysts See Lundin Gold’s Story Shifting With Higher Price Targets and Gold Forecasts

    The consensus analyst price target for Lundin Gold has risen slightly from CA$92.17 to CA$93.42, highlighting modestly increased expectations for the company’s fair value. This change comes amid more optimistic forecasts for gold and silver prices, and it reflects recent analyst reassessments of the sector. Stay tuned to find out how investors and analysts can keep informed about the evolving outlook for Lundin Gold.

    Analyst Price Targets don’t always capture the full story. Head over to our Company Report to find new ways to value Lundin Gold.

    🐂 Bullish Takeaways

    • BMO Capital increased its price target for Lundin Gold to C$104 from C$93 and maintained a Market Perform rating. This price target revision signals recognition of recent operational execution and market performance.

    • CIBC made a more substantial adjustment by raising its price target to C$116 from C$85. This reflects higher future gold and silver price forecasts, with CIBC now projecting gold at $4,500 per ounce and silver at $55 per ounce in 2026 and 2027.

    • These target increases are largely attributed to industry-wide updates in commodity price outlooks, rewarding Lundin Gold’s year-to-date stock outperformance and ongoing resilience in cost management.

    🐻 Bearish Takeaways

    • Despite the revised, more aggressive price targets, both CIBC and BMO Capital have maintained neutral stances (Neutral and Market Perform ratings, respectively). This indicates that some analysts believe current valuation already reflects much of the near-term upside.

    • CIBC notes that recent recommended price changes are in part a “catch-up” to reflect recent gold price movements, rather than a fundamental shift in expectations for the company’s execution or intrinsic value.

    Do your thoughts align with the Bull or Bear Analysts? Perhaps you think there’s more to the story. Head to the Simply Wall St Community to discover more perspectives or begin writing your own Narrative!

    TSX:LUG Community Fair Values as at Nov 2025
    • Lundin Gold reported strong results from exploration drilling at Fruta del Norte, making progress toward an initial Mineral Reserve estimate expected in early 2026. The company also achieved Reserve replacement in both 2023 and 2024, highlighting ongoing resource growth.

    • Positive drilling outcomes were announced at the Sandia, Trancaloma, and Castillo targets, with the discovery of new high-grade mineralized zones and further expansion potential in all directions.

    • For the third quarter and year-to-date 2025, Lundin Gold posted higher ore processing and gold recovery rates. Despite these improvements, the average head grade and doré output were slightly lower compared to the previous year.

    • A leadership change was announced. Ron Hochstein will step down as President, CEO and Director, with Jamie Beck appointed as new CEO effective November 7, 2025.

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  • Does Deutsche Bank’s 95% Stock Surge Signal More Room to Grow in 2025?

    Does Deutsche Bank’s 95% Stock Surge Signal More Room to Grow in 2025?

    • Curious whether Deutsche Bank’s stock is still good value after its recent rally? Let’s break down what seasoned investors need to know.

    • The stock has soared an eye-catching 95.7% over the last year and is up 82.1% year-to-date, though it dipped slightly by 1.5% over the past month.

    • Much of this momentum has been fueled by renewed optimism around the banking sector, as well as Deutsche Bank’s ongoing restructuring efforts. These efforts have garnered positive media attention and investor confidence worldwide.

    • For those focused on fundamentals, Deutsche Bank scores a 4 out of 6 on our valuation checks. This is a solid signal, but let’s dig deeper into traditional valuation approaches before revealing an even more insightful way to assess whether the stock is a bargain.

    Deutsche Bank delivered 95.7% returns over the last year. See how this stacks up to the rest of the Capital Markets industry.

    The Excess Returns valuation model helps investors assess whether a company is creating value above its cost of capital by comparing its return on equity to the required return. This approach focuses on both the efficiency of Deutsche Bank’s investments and its future growth prospects, rather than just current earnings or cash flows.

    Deutsche Bank’s Book Value stands at €40.49 per share, while its Stable EPS is projected at €3.61 per share, based on weighted return on equity estimates from 11 analysts. The bank’s Cost of Equity is €3.78 per share, resulting in a small negative Excess Return of €-0.17 per share. With an average return on equity of 9.52%, the company’s ability to generate returns just trails the required rate, and the Stable Book Value is forecast to be €37.88 per share according to 7 analyst projections.

    Using the Excess Returns method, Deutsche Bank’s intrinsic value implies the stock is currently 14.6% undervalued compared to its market price. This suggests the market may not yet be fully appreciating Deutsche Bank’s efforts to improve its earnings and capital efficiency.

    Result: UNDERVALUED

    Our Excess Returns analysis suggests Deutsche Bank is undervalued by 14.6%. Track this in your watchlist or portfolio, or discover 920 more undervalued stocks based on cash flows.

    DBK Discounted Cash Flow as at Nov 2025

    Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for Deutsche Bank.

    The Price-to-Earnings (P/E) ratio is widely considered a key tool for valuing profitable companies like Deutsche Bank, as it directly reflects how much investors are willing to pay for each euro of earnings. For established banks with steady profits, the P/E ratio can quickly indicate whether the stock price is in line with its financial performance.

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  • The OncFive: Top Oncology Articles for the Week of 11/23

    The OncFive: Top Oncology Articles for the Week of 11/23

    Welcome to OncLive®’s OncFive!

    Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

    Here’s what you may have missed this week:

    The FDA approved durvalumab (Imfinzi) for use in combination with FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) as neoadjuvant and adjuvant treatment, followed by single-agent durvalumab, for adult patients with resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma.1

    The regulatory decision was supported by findings from the phase 3 MATTERHORN trial (NCT04592913), which showed durvalumab plus FLOT reduced the risk of disease progression, recurrence, or death by 29% compared with FLOT alone; The median event-free survival (EFS) was not reached (95% CI, 40.7-not estimable [NE]) with durvalumab vs 32.8 months (95% CI, 27.9-NE) with FLOT alone. (HR, 0.71; 95% CI, 0.58-0.86; P < .001). The pathological complete response rate was 19.2% (95% CI, 15.7%-23.0%) in the durvalumab arm vs 7.2% (95% CI, 5.0%-9.9%) in the FLOT alone arm (P < .001).

    The FDA has granted priority review to a new drug application (NDA) seeking the approval of sonrotoclax (BGB-11417) for the treatment of adult patients with relapsed or refractory MCL who have received prior treatment with a BTK inhibitor.2

    The NDA is supported by findings from the phase 1/2 BGB-11417-201 trial (NCT05471843), which met its primary end point of overall response rate (ORR) per independent review committee (IRC) and showed clinically meaningful responses among 125 adult patients with relapsed/refractory disease previously treated with a BTK inhibitor. Full data from the study that support the NDA will be presented at the 2025 ASH Annual Meeting.

    Treatment with Sacituzumab tirumotecan (sac-TMT; SKB264/MK-2870) in combination with pembrolizumab (Keytruda) yielded a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs pembrolizumab alone in patients with PD-L1–positive advanced non–small cell lung cancer (NSCLC), meeting the primary end point of the phase 3 OptiTROP-Lung05 trial (NCT06448312).3

    Overall survival also trended in favor of the sac-TMT regimen, per independent data monitoring committee assessment. Based on these findings, an NDA could be submitted to the Center for Drug Evaluation of the National Medical Products Administration in China seeking the approval of sac-TMT in this indication.

    Treatment with subcutaneous toripalimab (JS001sc) in combination with chemotherapy generated comparable pharmacokinetics (PK) compared with intravenous (IV) toripalimab (Loqtorzi) plus chemotherapy in patients with recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC), meeting the primary end points of the phase 3 JS001sc-002-III-NSCLC trial (NCT06505837).4

    The study met both its primary end points: observed serum Ctrough concentration at cycle 1 and model-predicted area under the concentration time curve from 0 to 21 days at cycle 1. Findings also demonstrated that subcutaneous toripalimab produced comparable efficacy and safety outcomes compared with the IV formulation. Full trial data will be presented at an upcoming international medical conference.

    The European Commission approved lisocabtagene maraleucel (Breyanzi; liso-cel) for the treatment of adult patients with relapsed or refractory MCL following at least 2 prior lines of systemic therapy, including a BTK inhibitor.5

    This regulatory decision is supported by data from the MCL cohort of the phase 1 TRANSCEND NHL 001 trial (NCT02631044), which showed that liso-cel generated an ORR of 82.7% (95% CI, 72.7%-90.2%) and a complete response rate of 71.6% (95% CI, 60.5%-81.1%). The median time to first response was 0.95 months, and 41.2% (95% CI, 29.2%-52.9%) of patients remained in response at 24 months.

    References

    1. FDA approves durvalumab for resectable gastric or gastroesophageal junction adenocarcinoma. FDA. November 25, 2025. Accessed November 26, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma
    2. U.S. FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma. News release. BeOne Medicines. November 26, 2025. Accessed November 26, 2025. https://ir.beonemedicines.com/news/us-fda-grants-priority-review-to-sonrotoclax-for-the-treatment-of-relapsed-or-refractory-mantle/786f1dad-0c9f-492e-9fce-f9ceadd24989
    3. Kelun-Biotech announces phase 3 trial of sac-TMT in combination with Keytruda (pembrolizumab) as first-line treatment for PD-L1–positive NSCLC met primary endpoint. News Release. PR Newswire. November 24, 2025. Accessed November 26, 2025. https://www.prnewswire.com/news-releases/kelun-biotech-announces-phase-iii-trial-of-sac-tmt-in-combination-with-keytruda-pembrolizumab-as-first-line-treatment-for-pd-l1-positive-nsclc-met-primary-endpoint-302624279.html
    4. Junshi Biosciences announces primary endpoints met in JS001sc’s phase 3 study for the 1st-line treatment of NSQ-NSCLC. News release. Shanghai Junshi Biosciences. November 24, 2025. Accessed November 26, 2025. https://www.globenewswire.com/news-release/2025/11/25/3193998/0/en/Junshi-Biosciences-Announces-Primary-Endpoints-Met-in-JS001sc-s-Phase-3-Study-for-the-1ST-line-Treatment-of-NSQ-NSCLC.html
    5. Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory mantle cell lymphoma. News release. Bristol Meyers Squibb. November 24, 2025. Accessed November 26, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Receives-Approval-from-the-European-Commission-to-Expand-Use-of-CAR-T-Cell-Therapy-Breyanzi-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx

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