Merck & Co., Inc. operates as a healthcare company worldwide. It operates through two segments, Pharmaceutical and Animal Health. The Pharmaceutical segment offers human health pharmaceutical products in the areas of oncology, hospital acute care, immunology, neuroscience, virology, cardiovascular, and diabetes under the Keytruda, Bridion, Adempas, Lagevrio, Belsomra, Simponi, and Januvia brands, as well as vaccine products consisting of preventive pediatric, adolescent, and adult vaccines under the Gardasil/Gardasil 9, ProQuad, M-M-R II, Varivax, RotaTeq, Live Oral, Vaxneuvance, Pneumovax 23, and Vaqta names. The Animal Health segment discovers, develops, manufactures, and markets veterinary pharmaceuticals, vaccines, and health management solutions and services, as well as digitally connected identification, traceability, and monitoring products. The company serves drug wholesalers and retailers, hospitals, and government agencies; managed health care providers, such as health maintenance organizations, pharmacy benefit managers, and other institutions; and physicians, wholesalers, government entities, veterinarians, distributors, animal producers, farmers, and pet owners. It has development and commercialization agreement for three of Daiichi Sankyo's deruxtecan ADC candidates, which include patritumab deruxtecan, ifinatamab deruxtecan, and raludotatug deruxtecan for the treatment of multiple solid tumors both as monotherapy and/or in combination with other treatments; and AstraZeneca PLC to co-development and co-commercialize AstraZeneca's Lynparza products for multiple cancer types, and Koselugo for multiple indications. The company also has a collaboration agreement with Eisai Co., Ltd., Bayer AG, and Ridgeback Biotherapeutics LP, as well Moderna, Inc. Merck & Co., Inc. was founded in 1891 and is headquartered in Rahway, New Jersey.

Merck’s valuation looks expensive relative to the current quality of its earnings and balance sheet, so the base forecast should be cooled slightly. A P/E of 118.2x and P/B of 6.9x are noticeably above industry medians, while P/S of 5.5x and P/FCF of 22.9x also do not look cheap, especially against weak EPS momentum. At the same time, valuation multiples have generally remained elevated in recent periods, which suggests not a clear undervaluation but rather that the market is already pricing in an improvement that has not yet been fully confirmed by reported results. The company’s strength is still its decent margins: gross margin of about 73.9%, operating margin of 19.7%, and net margin of 13.6% are above or around industry benchmarks. However, margin trends have deteriorated compared with earlier periods, when net and operating margins were significantly higher, which limits rerating potential. ROE and return on tangible equity remain high, but ROA has fallen to 2.4%, indicating less efficient use of assets. The balance sheet looks more strained: debt/equity at 1.22x is above the median, debt has increased, and the current ratio of 1.30 and quick ratio of 1.06 are below comfortable industry levels. This is not critical for a large pharma company, but it does increase valuation sensitivity to a slowdown in cash flow and to the cost of capital. Revenue remains large and broadly stable, but profitability in absolute terms looks uneven: TTM net income and operating income are weak, and EBITDA also does not show convincing acceleration. Dividend yield currently does not support a strong income case, as the latest data show none, while it was moderate previously. Overall, the fundamentals support a moderately cautious view: the business is high quality and profitable, but expensive valuation, rising debt, and weaker short-term earnings momentum limit upside. For an investor, this means the target should be slightly lowered while still acknowledging the company’s strong long-term profile.

Merck & Company, Inc.

Сильный индекс, значительно упал. Оптимистичный взгляд на свои позиции резко сменился на неуверенность.

Strong index, significantly down. An optimistic view of his position suddenly changed to uncertainty.

Сильный индекс, без изменений. Рынок не поддерживает быков.

Strong index, flat. The market does not support the bulls.

Сильный индекс, без изменений. Отток средств из лонгов на высоком уровне.

Strong index, flat. Outflow of funds from longs at a high level.

Merck remains a high-quality pharmaceutical business, but expensive valuation multiples, rising debt, and weakening earnings outweigh strong margins and a high ROE.

Key Points
Johnson & Johnson has a rare and impressive streak of consecutive annual dividend increases.
Merck is facing multiple challenges, but it is demonstrating that it can overcome them.
Dividend investing will never go out of style. It's one of the best ways to take advantage of the magic of compounding (by reinvesting dividends), which can significantly boost long-term returns. And there is evidence that, over the past few decades, dividend-paying stocks have significantly outperformed non-dividend payers. But choosing a random income stock won't do -- they aren't all created equal. Let's consider two dividend-paying companies that look like excellent long-term picks: Johnson & Johnson (NYSE:JNJ) and Merck (NYSE:MRK).
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1. Johnson & Johnson
So far, it has been a good year for Johnson & Johnson, with the stock climbing 28%, compared to the S&P 500's 10% gain. One key reason for the company's performance is its strong financial results. Despite patent cliffs and government drug price negotiations, Johnson & Johnson is growing its revenue and earnings at a good clip. Second-quarter sales came in at $25.3 billion, up 6.6% year over year, while its adjusted earnings per share climbed 4.7% year over year to $2.90. Johnson & Johnson's recent financial results highlight its ability to overcome challenges.
It is doing so partly thanks to a large and diversified product lineup across pharmaceuticals and medical devices. It's difficult to find many healthcare companies more diversified than Johnson & Johnson, and that can help it perform well over the long run. Johnson & Johnson also continues to demonstrate its innovative abilities. The company's recent approvals include ICOTYDE, a medicine for plaque psoriasis, while its Ottava robotic-assisted surgery system, which could become an important growth driver down the road, has received marketing authorization.
Johnson & Johnson's pipeline features several dozen ongoing clinical trials, including some brand-new promising products. Beyond its core business, there has been some good news for Johnson & Johnson on other fronts recently. For instance, the company has moved closer to settling thousands of the talc-based lawsuits that have been a significant risk to the business for years. That's great news for investors.
Now turning to Johnson & Johnson's dividend program, it is also exceptional. The company has increased its payouts for 64 consecutive years, making it a Dividend King -- or a corporation with 50 consecutive years of dividend increases, at a minimum. Expect Johnson & Johnson to maintain healthy dividend growth over the next decade and deliver competitive returns, especially for those who reinvest dividends.
2. Merck
Merck should face increased competition for Keytruda, its biggest growth driver, moving forward. And the cancer drug will lose patent exclusivity by 2028. Meanwhile, the company's vaccine business, led by the HPV vaccines Gardasil and Gardasil 9 (which have sometimes been its most important products after Keytruda), has also faced headwinds in recent years. Can the stock really perform well through 2036? Yes, it can, and here is why.
Merck has already formulated a plan that should help it overcome the massive Keytruda patent cliff. It has earned approval for a subcutaneous formulation of the medicine -- called Keytruda Qlex -- that is much faster to administer and will help it retain patients beyond the original formulation's patent cliff. Merck has also earned approval for several new products that will help smooth out Keytruda-related losses.
Consider the company's second-quarter results. Its revenue increased 5% year over year to $16.6 billion. Sales of Winrevair, a recently approved treatment for pulmonary arterial hypertension, jumped 75% year over year to $588 million. Revenue from Capvaxive, a newer vaccine approved for pneumonia, climbed 42% year over year to $184 million. Further, Merck has several exciting pipeline candidates, including a personalized mRNA-based cancer vaccine it is developing with Moderna (NASDAQ:MRNA) that recently aced a phase 3 clinical trial in patients with melanoma. Merck should successfully navigate the Keytruda patent cliff, even if its sales initially decline, and perform well long after while still rewarding shareholders with regular dividend increases. Merck has increased its payouts by 93.79% over the past 10 years.
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2 Outstanding Dividend Stocks to Buy and Hold for 10 Years

Merck MRK is relying on a growing pipeline and an expanding portfolio of newer medicines, including acquired assets, to offset the eventual impact of the loss of exclusivity (LOE) for its blockbuster cancer drug Keytruda.
Keytruda remains Merck’s biggest revenue driver. The drug generated sales of $16.40 billion in the first half of 2026, up nearly 4.2% year over year. Though Keytruda will lose patent exclusivity in 2028, its sales are expected to remain strong until then. However, once biosimilars enter around 2028-2029, Keytruda’s sales are likely to decline sharply.
As Keytruda approaches its expected loss of exclusivity in 2028, Merck’s expanding drug pipeline and potential new blockbuster drugs are expected to drive the next phase of growth.
Merck’s phase III pipeline has almost tripled since 2021, supported by in-house progress as well as the addition of candidates through ongoing mergers and acquisitions (M&A) deals. Merck expects to launch 20 new drugs by 2030, with many already launched and carrying blockbuster potential.
Some newer products are already emerging as key growth drivers for Merck, including pulmonary arterial hypertension drug Winrevair, the 21-valent pneumococcal conjugate vaccine Capvaxive and cancer drug Welireg.
Winrevair and Capvaxive generated $1.1 billion and $325 million, respectively, in first-half 2026 sales. Welireg sales surged 57% year over year to $470 million. Strong launches position these drugs as potential long-term revenue contributors, especially in the post-Keytruda era.
Merck has also secured approvals for several newer products, including RSV antibody Enflonsia (clesrovimab), HIV treatment Idvynso, a once-daily, single-tablet, two-drug regimen of doravirine and islatravir, and Lipfendra (enlicitide), an oral PCSK9 inhibitor for lowering LDL cholesterol in adults with hypercholesterolemia.
Some key candidates in late-stage development are sacituzumab tirumotecan or sac-TMT, an anti-TROP2 antibody-drug conjugate for multiple tumor types, MK-8591D/islatravir plus lenacapavir, a once-weekly oral treatment for HIV, and alimatravir, a monthly oral HIV PrEP candidate.
Importantly, several of these higher-value programs are now moving from pipeline studies toward commercial validation. Merck expects more than $70 billion of potential non-risk-adjusted commercial opportunity for the current pipeline by the mid-2030s. This estimate is more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028.
The company has also stepped up acquisitions ahead of Keytruda’s 2028 patent expiry. Deals for Verona Pharma, Cidara Therapeutics and Terns Pharmaceuticals have expanded its pipeline across COPD, influenza and oncology, respectively.
Reflecting Merck’s evolving business mix, management expects the Keytruda LOE period to look like a “shallow dip with a fast return back to growth” as faster-than-expected pipeline de-risking, new products and acquired assets help diversify the portfolio and support long-term growth.
PD-L1 Inhibitors Competing With MRK's Keytruda
Keytruda faces competition from other PD-L1 inhibitors, including Bristol Myers’ BMY Opdivo, Roche’s RHHBY Tecentriq and AstraZeneca’s AZN Imfinzi.
BMY’s Opdivo, like Keytruda, is approved across multiple cancer types, including lung, melanoma and kidney cancers. Bristol Myers recorded $4.63 billion in Opdivo sales in the first half of 2026, down 3.9% year over year.
Tecentriq is Roche’s leading immuno-oncology drug approved for multiple cancer indications. RHHBY recorded CHF 1.70 billion in Tecentriq sales in the first half of 2026, up 6% year over year.
AZN’s Imfinzi generated sales of $3.55 billion in the first half of 2026, up 29%, driven by strong demand growth across all regions from established indications and new launches. Imfinzi has strategically expanded its use across multiple cancer indications, strengthening AstraZeneca’s oncology portfolio.
MRK's Price Performance, Valuation and Estimates
Year to date, shares of Merck have rallied 39.5% compared with the industry’s 12.3% rise. The stock has also outperformed the sector and the S&P 500 during the same time frame, as seen in the chart below.
Image Source: Zacks Investment Research
From a valuation standpoint, Merck appears to be trading at a premium compared with the industry. Going by the price/earnings ratio, MRK’s shares currently trade at 18.97 forward earnings, higher than 18.02 for the industry. The stock is also trading above its 5-year mean of 12.91.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 earnings per share has declined from $3.76 to $2.97, while the same for 2027 has decreased from $9.85 to $9.66 over the past 60 days.
Image Source: Zacks Investment Research
MRK's Zacks Rank
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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MRK Banks on Growing Pipeline & New Drugs to Offset Keytruda LOE

Key Points
To brace against market pullbacks, add some defensive stocks or funds to your mix.
Defensive industries include healthcare, utilities, and consumer staples.
Dividend payers can be great to hold in market downturns, too.
Is a stock market crash imminent? Well, no one knows for sure, but roughly 38% of investors surveyed by the American Association of Individual Investors reported expecting the stock market to decline over the coming six months (as of early September). Another worrisome sign is the S&P 500's historically high valuation. The cyclically adjusted price-to-earnings (CAPE) ratio was recently at 41.4, far higher than its long-term average of 17.4 and close to an all-time high of 44 reached in 1999 before the dot-com bubble turned into a crash.
It's generally not smart to jump out of the market fearing a crash -- because that's market timing -- and your timing may well be off. Instead, to calm your jitters, you might just invest in some exchange-traded funds (ETFs) that are built to withstand bear markets better than average investments.
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A market crash or correction will happen one of these days. Here are some ETFs to consider, to brace against that. Each is focused on a "defensive" part of the economy -- on businesses that consumers will generally keep buying from, no matter how the economy is doing.
Vanguard Health Care Index Fund ETF
The Vanguard Health Care Index Fund ETF (NYSEMKT: VHT) is a prime example. In a recession, people will still need healthcare -- they will still buy their medications (to the degree that they're able to) and will still visit doctors. This fund recently held 417 stocks, with top holdings including Eli Lilly, Johnson & Johnson, and UnitedHealth Group. Its annual fee is just 0.09%, costing you $9 annually for every $10,000 you have invested in the fund, and its dividend yield was recently 1.5%.
State Street Utilities Select Sector SPDR ETF
The State Street Utilities Select Sector SPDR ETF (NYSEMKT: XLU) also has a low annual fee -- just 0.08% -- and its dividend yield was recently 2.8%. It's focused on utility-related companies, such as NextEra Energy, Southern Co., and Duke Energy, and it recently held about 31 of them. When the economy flags, people and businesses will still need to keep the lights on.
Vanguard Consumer Staples Index Fund ETF Shares
The Vanguard Consumer Staples Index Fund ETF Shares (NYSEMKT: VDC) specializes in consumer staples companies, recently holding 103 of them, such as Walmart, Procter & Gamble, and Coca-Cola. Its annual fee is 0.09%, and its recent dividend yield 2.1%. Clearly, no matter whether the economy is up or down, gobs of people will want to keep buying shampoo, soda, and items from Walmart.
Schwab U.S. REIT ETF
The Schwab U.S. REIT ETF (NYSEMKT: SCHH) is another defensive ETF, in that it holds many real estate investment trusts (REITs) -- companies that buy properties and lease them out. These are typically multiyear leases, if not multidecade, so that income is likely to keep rolling to the REITS. The ETF's annual fee is just 0.07%, and its recent dividend yield 2.8%. Its recent 117 holdings included Prologis, American Tower, and Realty Income.
Schwab U.S. Dividend Equity ETF
A solid dividend-focused ETF such as the Schwab U.S. Dividend Equity ETF (NYSEMKT: SCHD) is also worth considering. (There are other good dividend ETFs, too, of course.) Why? Because dividend-paying companies tend to be established and profitable, with relatively dependable income. So they're more solid than the average stock. This ETF has an ultra-low annual fee of 0.06% and a recent dividend yield of 3%. Its top holdings (out of 98) recently included Merck, Chevron, and Verizon Communications.
Dividend income is particularly nice during recessions because while some stocks may be stagnating, healthy dividend payers will keep delivering cash to shareholders.
Whether the stock market pulls back this year, next year, or the year after, these ETFs will likely keep growing -- and delivering a little income regularly, too. Take a closer look at any of these funds that intrigue you.
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Selena Maranjian has positions in American Tower, NextEra Energy, Procter & Gamble, Realty Income, Schwab U.S. Dividend Equity ETF, and Verizon Communications. The Motley Fool has positions in and recommends American Tower, Chevron, Eli Lilly, Merck, NextEra Energy, Prologis, Realty Income, and Walmart. The Motley Fool recommends Duke Energy, Johnson & Johnson, UnitedHealth Group, and Verizon Communications. The Motley Fool has a disclosure policy.

These 5 ETFs Are Built for Bear Markets. History Says Now Is a Fantastic Time to Buy.

Looking today at week-over-week shares outstanding changes among the universe of ETFs covered at ETF Channel, one standout is the Vanguard High Dividend Yield ETF (Symbol: VYM) where we have detected an approximate $515.6 million dollar inflow -- that's a 0.6% increase week over week in outstanding units (from 504,185,997 to 507,339,414). Among the largest underlying components of VYM, in trading today UnitedHealth Group Inc (Symbol: UNH) is down about 3.6%, Procter & Gamble Company (Symbol: PG) is down about 1.6%, and Merck & Co Inc (Symbol: MRK) is lower by about 0.6%. For a complete list of holdings, visit the VYM Holdings page » The chart below shows the one year price performance of VYM, versus its 200 day moving average:
Looking at the chart above, VYM's low point in its 52 week range is $137.42 per share, with $167.61 as the 52 week high point — that compares with a last trade of $162.91. Comparing the most recent share price to the 200 day moving average can also be a useful technical analysis technique -- learn more about the 200 day moving average ».
Exchange traded funds (ETFs) trade just like stocks, but instead of ''shares'' investors are actually buying and selling ''units''. These ''units'' can be traded back and forth just like stocks, but can also be created or destroyed to accommodate investor demand. Each week we monitor the week-over-week change in shares outstanding data, to keep a lookout for those ETFs experiencing notable inflows (many new units created) or outflows (many old units destroyed). Creation of new units will mean the underlying holdings of the ETF need to be purchased, while destruction of units involves selling underlying holdings, so large flows can also impact the individual components held within ETFs.
Further VYM Research:

VYM, UNH, PG, MRK: Large Inflows Detected at ETF

Tuesday, September 8, 2026
The Zacks Research Daily presents the best research output of our analyst team. Today's Research Daily features new research reports on 16 major stocks, including Oracle Corp. (ORCL), Merck & Co., Inc. (MRK) and Union Pacific Corp. (UNP), as well as two micro-cap stocks CVD Equipment Corp. (CVV) and Koil Energy Solutions, Inc. (KLNG). The Zacks microcap research is unique as our research content on these small and under-the-radar companies is the only research of its type in the country.
These research reports have been hand-picked from the roughly 70 reports published by our analyst team today.
You can see all of today’s research reports here >>>
Ahead of Wall Street
The daily 'Ahead of Wall Street' article is a must-read for all investors who would like to be ready for that day's trading action. The article comes out before the market opens, attempting to make sense of that morning's economic releases and how they will affect that day's market action. You can read this article for free on our home page and can actually sign up there to get an email notification as this article comes out each morning.
You can read today's AWS here >>> Canadian Tariffs Hit $20B in U.S. Imports
Today's Featured Research Reports
Shares of Oracle have gained +10.8% over the past six months against the Zacks Computer - Software industry’s gain of +16.4%. The company’s cloud infrastructure business demonstrates accelerating revenue growth, supported by strategic partnerships and competitive pricing that attract enterprise workload migrations.
AI-optimized database capabilities provide technological differentiation, while record fiscal 2026 operating cash flow of $32 billion enables sustained infrastructure investments. The integrated solutions strategy strengthens customer retention and drives cross-selling opportunities.
However, competition from hyperscalers remains intense, potentially pressuring margins. The ongoing transition from license revenue to subscription models creates near-term earnings volatility. Q1 fiscal 2027 guidance indicates total revenue growth of 27-29%, but execution risks around data center capacity expansion and funding requirements warrant monitoring.
(You can read the full research report on Oracle here >>>)
Merck’s shares have outperformed the Zacks Large Cap Pharmaceuticals industry over the past six months (+29.1% vs. +14%). The company’s blockbuster drug, Keytruda, and new products have been driving sales. Animal Health is also contributing to growth. Though Keytruda will lose patent exclusivity in 2028, its sales are expected to remain strong until then.
Recent M&A deals have strengthened Merck’s pipeline while its late-stage pipeline and new launches are gaining traction. This progress has increased confidence that Merck can maintain growth even after Keytruda loses exclusivity.
However, it faces several near-term challenges, including persistent challenges for Gardasil, potential competition for Keytruda, and rising competitive and generic pressure on some of its drugs. Also, estimates have declined recently due to costs related to its various M&A deals.
(You can read the full research report on Merck here >>>)
Shares of Union Pacific have outperformed the Zacks Transportation - Rail industry over the past six months (+15.5% vs. +15%). The company remains a high-quality rail franchise with a balanced risk-reward profile. Domestic intermodal growth, reliable service and productivity gains support volume capture across an uneven freight market. Pricing continues to exceed inflation, while cash generation and lower leverage support investment and dividend growth.
Management’s improved earnings outlook reflects continued operating discipline. The proposed Norfolk Southern combination could broaden the network and improve long-term service, with regulatory commitments marking progress.
Still, freight demand remains mixed, coal and some industrial markets are soft, and fuel and labor costs can pressure margins. The merger also brings approval, financing, integration and dilution risks, while buybacks remain paused. These offsets support the Neutral recommendation.
(You can read the full research report on Union Pacific here >>>)
CVD Equipment’s shares have outperformed the Zacks Manufacturing - General Industrial industry over the past six months (+81.9% vs. -5%). This microcap company with a market capitalization of $45.67 million, has an investment case resting on its exposure to opportunities in ceramic matrix composites (CMCs), advanced battery materials, silicon carbide (SiC) applications and industrial and nuclear markets. Its installed equipment base provides scope for recurring aftermarket revenues as customer utilization rises.
Operational restructuring and the SDC divestiture have strengthened financial flexibility and created a leaner platform for future growth. However, the outlook remains tempered by volatile system bookings, customer concentration, weak SiC demand, elevated R&D spending and dependence on successful commercialization of newer products.
The valuation implies that investors continue to discount execution and demand risks. This could provide upside if order momentum and revenue visibility improve, but sustained weakness in bookings may limit rerating potential.
(You can read the full research report on CVD Equipment here >>>)
Shares of Koil Energy Solutions have outperformed the Zacks Alternative Energy - Other industry over the past six months (+37.6% vs. -9.8%). This microcap company with a market capitalization of $42.21 million saw its first-half 2026 results highlight strengthening growth and operating leverage, with revenues up 67% and operating income improving to $1 million from a year-ago loss.
Momentum is being driven by higher fixed-price and service revenues, meaningful contributions from new customers, expanding carousel rental activity and entry into Brazil. Broader exposure across West Africa, the Middle East and Asia Pacific, along with healthy subsea tieback and maintenance demand, further supports the growth outlook.
However, cash conversion remains weak, as higher receivables pushed operating cash flow negative, while rising capital spending and borrowing increase liquidity and financing risks. Results also depend heavily on a few large projects, making revenues vulnerable to execution delays and uneven recognition. Valuation is mixed, with EV/sales below industry levels but EV/EBITDA elevated.
(You can read the full research report on Koil Energy Solutions here >>>)
Other noteworthy reports we are featuring today include Phillips 66 (PSX), Intuit Inc. (INTU) and Flex Ltd. (FLEX).
Mark Vickery
Senior Editor
Note: Sheraz Mian heads the Zacks Equity Research department and is a well-regarded expert of aggregate earnings. He is frequently quoted in the print and electronic media and publishes the weekly Earnings Trends and Earnings Preview reports. If you want an email notification each time Sheraz publishes a new article, please click here>>>
Today's Must Read
Featured Reports
AI, QuickBooks Growth Aids Intuit (INTU), Tax Reset Clouds the Outlook
Per the Zacks analyst, Intuit benefits from QuickBooks, Credit Karma and AI tech that support engagement and monetization. However, slower customer growth, Mailchimp churn and tax pricing reset weigh.
FLEX Gains from Expanding Data Center Platform & Acquisitions
Per the Zacks analyst, Flex continues to deepen its exposure to the data center market through its Cloud and Power Infrastructure segment. Also, synergies from acquisitions bode well.
Rising Total Loss Frequency Aids Copart (CPRT) Amid High Opex
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Shipbuilding Leadership, Rising Backlog Aid Huntington Ingalls (HII)
Per the Zacks analyst, Huntington Ingalls should benefit from strong shipbuilding demand, rising backlog and a supportive defense budget. Autonomous systems, program wins support long-term growth.
Power Growth & Teledata Strength Aid Argan (AGX), Project Risks Ail
Per the Zacks analyst, Argan benefits from higher Power activity, Teledata growth and a strong backlog. However, project concentration and execution risks remain concerns.
DENTSPLY SIRONA (XRAY) Balances Digital Growth With Turnaround Risks
As per the Zacks analyst, digital dentistry, SureSmile and restructuring offer upside, while weak equipment demand, orthodontics pressure and tariffs could limit DENTSPLY SIRONA's turnaround.
Spectrum Brands (SPB) Gains From Growth, Innovation and Discipline
Per the Zacks analyst, Spectrum Brands has been benefiting from brand investment, pricing, productivity and strong liquidity, supporting growth despite ongoing demand and cost pressures.
New Upgrades
Phillips 66's (PSX) Diversified Business Model Drives Resilience
Per the Zacks analyst, Phillips 66's diversified business platform supports earnings resilience. Its focus on shareholder returns and balance-sheet strength is also a key positive.
AI-Enabled PCs to Aid HP (HPQ) Personal Systems Revenues
Per the Zacks analyst, growing interest in artificial intelligence-enabled PCs will give a fresh boost to HP's Personal Systems segment revenue growth.
Popular (BPOP) Financial Rides on Loan Growth & Solid Liquidity
Per the Zacks analyst, Popular's steady rise in loan balances underscores its solid organic growth momentum. Further, its robust liquidity profile aids consistent capital distribution activities.
New Downgrades
TG Therapeutics' (TGTX) Briumvi Dependence for Sales Raises Concerns
Per the Zacks analyst, TG Therapeutics' sole dependence on multiple sclerosis drug, Briumvi, for revenues is concerning. Competition in the target market also remains a woe.
Asphalt Customer Shift, High Interest Costs Weigh on Astec (ASTE)
The Zacks analyst is concerned that macro uncertainty is delaying deliveries for some asphalt customers and elevated interest expenses will continue to hurt Astec Industries' results.
Western Union (WU) Faces Retail Weakness and Margin Pressure
Per the Zacks analyst, Western Union's retail weakness, margin pressure and elevated leverage remain concerns despite growth in Digital and Consumer Services.
Zacks' Research Chief Names "Stock Most Likely to Double"
Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.
This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%.
Free: See Our Top Stock And 4 Runners Up
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This article originally published on Zacks Investment Research (zacks.com).

Top Stock Reports for Oracle, Merck & Union Pacific

The NASDAQ 100 After Hours Indicator is down -4.9 to 29,502.8. The total After hours volume is currently 204,756,119 shares traded.
The following are the most active stocks for the after hours session:
AtaiBeckley Inc. (ATAI) is +0.05 at $7.33, with 25,358,660 shares traded. ATAI's current last sale is 93.08% of the target price of $7.875.
Nu Holdings Ltd. (NU) is +0.0015 at $15.33, with 10,419,054 shares traded. NU's current last sale is 82.65% of the target price of $18.55.
Transocean Ltd. (RIG) is +0.02 at $5.78, with 7,728,392 shares traded. RIG's current last sale is 96.33% of the target price of $6.
NVIDIA Corporation (NVDA) is -0.0617 at $225.67, with 6,274,218 shares traded. Over the last four weeks they have had 10 up revisions for the earnings forecast, for the fiscal quarter ending Oct 2026. The consensus EPS forecast is $2.47. As reported by Zacks, the current mean recommendation for NVDA is in the "buy range".
Coca-Cola Company (The) (KO) is +0.05 at $88.41, with 5,954,136 shares traded. As reported by Zacks, the current mean recommendation for KO is in the "buy range".
AT&T Inc. (T) is -0.01 at $25.59, with 4,754,636 shares traded. As reported by Zacks, the current mean recommendation for T is in the "buy range".
Amer Sports, Inc. (AS) is +0.11 at $28.80, with 4,530,897 shares traded. As reported by Zacks, the current mean recommendation for AS is in the "buy range".
Walmart Inc. (WMT) is unchanged at $106.05, with 4,203,325 shares traded. Over the last four weeks they have had 3 up revisions for the earnings forecast, for the fiscal quarter ending Jul 2027. The consensus EPS forecast is $0.84. As reported by Zacks, the current mean recommendation for WMT is in the "buy range".
Merck & Company, Inc. (MRK) is unchanged at $148.46, with 3,866,958 shares traded. As reported by Zacks, the current mean recommendation for MRK is in the "buy range".
Huntington Bancshares Incorporated (HBAN) is unchanged at $16.76, with 3,624,129 shares traded. As reported by Zacks, the current mean recommendation for HBAN is in the "buy range".
ON Semiconductor Corporation (ON) is +0.17 at $71.25, with 3,585,929 shares traded. ON's current last sale is 71.97% of the target price of $99.
Apple Inc. (AAPL) is +0.13 at $316.35, with 3,432,821 shares traded. AAPL's current last sale is 94.43% of the target price of $335.

After Hours Most Active for Sep 8, 2026 : ATAI, NU, RIG, NVDA, KO, T, AS, WMT, MRK, HBAN, ON, AAPL

Moderna MRNA shares have surged 143% in the past month, driven largely by recently announced positive late-stage results for a personalized mRNA-based cancer therapy being developed in partnership with Merck MRK.
Oncology Win Highlights Moderna’s Potential Beyond Vaccines
The latest results give investors a stronger reason to view the company’s mRNA platform as having potential beyond vaccines targeting infectious disease. The personalized mRNA-based therapy, called intismeran autogene (V940/mRNA-4157), delivered positive results in high-risk melanoma patients whose tumors had been removed through surgery. When combined with Merck’s blockbuster oncology drug Keytruda, the therapy met the study’s primary endpoint of recurrence-free survival, or the length of time patients remain free of cancer recurrence. The combination also achieved a key secondary endpoint of distant metastasis-free survival, indicating that patients remained free of cancer spread for longer.
The significance of these results extends beyond melanoma. Moderna and Merck are studying intismeran in several other cancer types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma. Positive results across these programs could substantially expand the therapy’s commercial opportunity and give Moderna an important growth avenue outside its vaccine portfolio.
While the recent development represents a potentially significant new growth driver for Moderna and strengthens the long-term value of its mRNA platform, investors need to weigh the company’s broader fundamentals before determining how to play the stock.
Moderna Continues Expanding Respiratory Portfolio
Moderna continues to expand its respiratory portfolio as it works to build growth opportunities beyond its COVID-19 vaccine business. The company has broadened its presence into RSV with mResvia and seasonal influenza with mFlusiva. In the meantime, Moderna’s pipeline includes additional respiratory programs, such as a combination influenza and COVID-19 vaccine, as well as candidates targeting diseases including bird flu and norovirus.
The company also remains committed to the COVID-19 market. MRNA recently secured FDA approval for updated 2026/2027 formulations of Spikevax and mNexspike, demonstrating that it is continuing to compete in the COVID-19 segment even as demand has normalized. Maintaining a presence in the market while expanding into other respiratory categories could help Moderna diversify its vaccine business and reduce its reliance on COVID-19 sales over the longer term.
Moderna Has a Clear Roadmap for Future Growth
The success of intismeran is particularly significant in light of Moderna’s three-horizon strategy outlined at an investor event earlier this year. The company places intismeran in Horizon 1 alongside its established infectious-disease vaccines and rare-disease therapeutics. These programs represent the company’s near-term opportunities as Moderna works to build multiple growth engines beyond its COVID-19 franchise.
Moderna’s longer-term ambitions become more evident in the later horizons. Horizon 2 includes additional mRNA-based therapeutic approaches already moving through development, including cancer antigen therapies, T-cell engagers, cell-therapy enhancers and an investigational therapy for multiple sclerosis. Horizon 3 comprises earlier-stage technologies, including in-vivo CAR-T and CAR-M cell therapies, which could become future growth platforms for the company.
Taken together, the three horizons show that Moderna is looking to evolve from a vaccine-maker into a diversified pharmaceutical company. The success with intismeran therefore represents not only an important milestone for one oncology program but also a meaningful proof point for Moderna’s strategy to apply its technology across multiple therapeutic areas.
Competition Poses a Concern
Moderna faces established competitors across the respiratory markets it is targeting. In RSV, mResvia competes with Pfizer’s PFE Abrysvo and GSK’s Arexvy.
The company recently entered the seasonal influenza market, which is dominated by large players such as Sanofi, CSL Seqirus and GSK. The competitive landscape could become even more challenging as GSK advances its own mRNA-based flu vaccine into late-stage development, following positive phase II results.
The competitive pressure also extends to COVID-19 vaccines, where Moderna faces Pfizer/BioNTech BNTX and Sanofi/Novavax. Competition could intensify further in combination vaccines as these companies develop candidates that target both influenza and COVID-19, potentially increasing the pressure on pricing and market share.
In oncology, the challenge is broader than competing for market share in a single indication. BioNTech is also developing an individualized mRNA-based cancer immunotherapy in collaboration with Roche, putting the two companies on a path to compete in the emerging personalized oncology market. As Moderna seeks to expand intismeran across multiple tumor types, its ability to differentiate the therapy, secure regulatory approvals and execute a successful commercial launch will be critical to realizing its potential.
MRNA Stock Performance, Valuation & Estimates
Year to date, MRNA stock has skyrocketed nearly 400% compared with the industry’s 10% growth, as seen in the chart below. During this timeframe, the stock also outdid the broader Medical sector and the S&P 500 Index.
MRNA Stock Outperforms Industry, Sector & S&P 500
From a valuation standpoint, Moderna appears to be trading at a premium compared to the industry. Based on the price/sales (P/S) ratio, the company’s shares currently trade at 26 times trailing 12-month sales, higher than 2.58 for the industry.
The Zacks Consensus Estimate for Moderna’s 2026 loss per share have improved from $8.57 to $8.50 in the past 30 days. However, the consensus mark for 2027 has narrowed from $4.67 to $4.52 during the same period.
How to Play MRNA Stock?
Moderna’s outlook is improving as the company develops growth opportunities across oncology while expanding into other therapeutic areas. However, the turnaround is likely to take time. Products such as mFlusiva are still in the early stages of building commercial momentum, while the larger potential from oncology remains dependent on additional clinical, regulatory and commercial milestones.
Although estimates for Moderna’s losses have improved, a meaningful recovery in financial performance is likely to develop gradually as newer products gain traction and pipeline opportunities move closer to commercialization. Investors should therefore focus less on a rapid recovery in financial performance and more on whether Moderna can steadily establish new sources of growth.
Therefore, we advise investors with a long-term horizon to stay invested in this Zacks Rank #3 (Hold). The improving earnings outlook and expanding pipeline strengthen Moderna’s long-term growth prospects, but investors should remain patient as the company works to translate its pipeline investments into sustainable commercial growth.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Research Chief Names "Stock Most Likely to Double"
Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.
This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%.
Free: See Our Top Stock And 4 Runners Up
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
This article originally published on Zacks Investment Research (zacks.com).

MRNA Stock Soars 143% in a Month: Time to Buy, Hold or Sell?

Merck’s MRK stock is trading near its 52-week high range for some days now. On Sept. 4, MRK closed at $150.33 versus its 52-week high of $156.92 reached on Aug. 25, leaving it only about 4% below the peak.
Last month, Merck and Moderna MRNA announced positive top-line data from a phase III study, which evaluated their personalized cancer therapy combo as an adjuvant treatment for patients with completely resected stage IIB-IV melanoma. The phase III INTerpath-001 study evaluated Moderna’s investigational mRNA-based individualized neoantigen therapy (“INT”), intismeran autogene, in combination with Merck’s blockbuster PD-L1 inhibitor, Keytruda. The study met its primary endpoint of recurrence-free survival (“RFS”) and key secondary endpoint of distant metastasis-free survival (“DMFS”).
In addition to this positive development, Merck’s improving fundamentals and increasing confidence in its post-Keytruda growth strategy helped the stock reach a new 52-week high last month.
Let’s understand the company’s strengths and weaknesses to understand how to play the stock in such a scenario.
Keytruda Powers Merck’s Growth
Merck boasts more than six blockbuster drugs in its portfolio, with Keytruda being the key top-line driver. Keytruda, approved for several types of cancer, alone accounts for more than 55% of the company’s pharmaceutical sales. In the United States, Keytruda is approved for 44 indications spanning 19 tumor types as well as for many of these indications worldwide.
The drug has played an instrumental role in driving Merck’s steady revenue growth over the past few years. Keytruda sales are gaining from continued strong momentum in metastatic indications and rapid uptake across earlier-stage launches. The company expects the growth to continue till it loses patent exclusivity in 2028. More than 2,800 clinical studies are currently evaluating Keytruda across multiple cancer types and treatment settings.
Merck is working on different strategies to drive Keytruda's long-term growth. These include innovative immuno-oncology combinations, including Keytruda with LAG3 and CTLA-4 inhibitors. As discussed previously, in partnership with Moderna, Merck is developing intismeran autogene in combination with Keytruda in nine phase II and phase III studies across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.
Merck’s subcutaneous formulation of Keytruda, known as Keytruda Qlex, was approved in the United States and EU in 2025 and generated sales of $590 million in the first half of 2026. Keytruda Qlex can offer substantially quicker administration time than the intravenous infusion of Keytruda.
The company expects Keytruda to achieve peak sales of $35 billion by 2028. Merck’s other oncology drugs, Welireg, AstraZeneca AZN-partnered Lynparza and Eisai-partnered Lenvima, are also contributing to top-line growth.
Merck’s Animal Health business is also a key contributor to its top-line growth, with sales expected to more than double by the mid-2030s.
MRK’s Pipeline Offers a Path Beyond Keytruda
Merck’s expanding drug pipeline and potential new blockbuster drugs beyond Keytruda look encouraging.
Its phase III pipeline has almost tripled since 2021, supported by in-house progress as well as the addition of candidates through M&A deals. Merck expects to launch 20 new drugs by 2030, with many already launched.
Its new products, pulmonary arterial hypertension drug Winrevair, cancer drug Welireg and 21-valent pneumococcal conjugate vaccine Capvaxive, have begun to contribute significantly to top-line growth.
Some new products approved/launched recently are RSV antibody, Enflonsia (clesrovimab), Idvynso, a once-daily, single-tablet two-drug regimen of doravirine and islatravir, and Lipfendra (enlicitide), an oral PCSK9 inhibitor to help reduce LDL cholesterol in adults with hypercholesterolemia.
Some key candidates in late-stage development are sacituzumab tirumotecan or sac-TMT, an anti-TROP2 antibody-drug conjugate for multiple tumor types, MK-8591D/islatravir plus lenacapavir, a once-weekly oral treatment for HIV, and alimatravir, a monthly oral HIV PrEP candidate.
Merck is actively pursuing acquisitions to prepare for Keytruda’s 2028 patent expiration. Recent deals added Ohtuvayre through Verona Pharma, influenza candidate MK-1406 through Cidara, and potential blockbuster cancer drug MK-4208 through Terns Pharmaceuticals.
Declining Sales of MRK’s Gardasil & Other Vaccines
Merck’s Gardasil/Gardasil 9 franchise is facing a significant slowdown, with sales declining 9% in the first half of 2026 due to weaker demand in China, Japan and the United States. China remains the biggest challenge, as economic weakness has dampened demand and led to elevated channel inventories at partner Zhifei, prompting Merck to temporarily halt shipments.
Although limited shipments resumed in China in the second quarter under a revised agreement, the growing availability of lower-cost domestic HPV vaccines could further put pressure on Gardasil, an imported premium-priced vaccine, with China revenues expected to remain immaterial in 2026. In the United States, demand is also being hurt by changes in vaccination recommendations, including greater use of single-dose schedules.
Sales of some other Merck vaccines, like Proquad, M-M-R II, Varivax, Rotateq and Vaxneuvance, also declined in the first half of 2026.
MRK Faces a Looming Keytruda Patent Cliff
Merck is heavily reliant on Keytruda. Though Keytruda may be Merck’s biggest strength and a solid reason to own the stock, the company is excessively dependent on the drug. Keytruda’s core U.S. patent is expected to expire around 2028, with additional patents expiring slightly after that. Keytruda is expected to face significant biosimilar competition around 2028-2029. Once biosimilars enter, Keytruda’s sales are likely to decline sharply.
Also, competitive pressure might increase for Keytruda in the near future from dual PD-1/VEGF inhibitors that inhibit both the PD-1 pathway and the VEGF pathway at once. They are designed to overcome the limitations of single-target therapies like Keytruda.
Generic Headwinds for MRK in 2026
MRK is seeing declining demand for its diabetes products (Januvia/Janumet) and the generic erosion of some drugs like Isentress/Isentress HD and Bridion in the European Union and Dificid in the United States. Bridion lost market exclusivity in the United States in July 2026 and sales are expected to decline further in future quarters. Januvia and Janumet lost market exclusivity in the United States in May 2026 and Janumet XR in July 2026. Sales of Januvia/Janumet are expected to decline steeply in future quarters due to the government price setting in 2026 and 2027, the patent expiry in 2026 and ongoing competitive pressure.
MRK Share Price, Valuation & Estimates
Merck’s shares have risen 42.8% so far this year compared with an increase of 14.5% for the industry. The stock has also outperformed the sector as well as the S&P 500 index, as seen in the chart below.
Merck Stock Outperforms Industry, Sector & S&P 500
Image Source: Zacks Investment Research
From a valuation standpoint, Merck is slightly expensive. Going by the price/earnings ratio, the company’s shares currently trade at 19.85 forward earnings, higher than 18.70 for the industry. The stock is trading above its 5-year mean of 12.90.
MRK Stock Valuation
Image Source: Zacks Investment Research
Estimates for MRK’s 2026 earnings have declined from $4.31 per share to $2.97 per share over the past 60 days, while those for 2027 have declined from $9.85 per share to $9.66 per share.
MRK Estimate Movement
Image Source: Zacks Investment Research
Stay Invested in MRK Stock
Merck has one of the world’s best-selling drugs in its portfolio, generating billions of dollars in revenues. Though Keytruda will lose patent exclusivity in 2028, its sales are expected to remain strong until then.
It expects more than $70 billion of potential non-risk-adjusted commercial opportunity for the current pipeline by the mid-2030s. This estimate is more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028.
Merck faces several near-term challenges, including persistent challenges for Gardasil, potential competition for Keytruda, and rising competitive and generic pressure on some of its drugs. Near-term profitability remains affected by costs related to Merck’s various acquisitions. However, these acquisitions eventually benefit the company.
Meanwhile, its new products, strong progress in its pipeline, and business development and acquisitions have increased confidence that Merck may be able to maintain growth even after Keytruda loses exclusivity. Investors can continue to retain this Zacks Rank #3 (Hold) stock as its long-term prospects remain intact. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Research Chief Names "Stock Most Likely to Double"
Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.
This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%.
Free: See Our Top Stock And 4 Runners Up
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
This article originally published on Zacks Investment Research (zacks.com).

Merck Trading Near 52-Week High: Is the Stock a Buy, Hold or Sell?

Key Points
Moderna's shares have pulled back since their most recent highs.
The biotech's latest clinical milestone makes its prospects far more attractive.
It's not too late to invest in the stock.
Moderna (NASDAQ: MRNA) has been one of the better-performing large-cap biotechs this year. The company's shares are up 404% to date and have soared 515% over the trailing-12-month period (as of writing). The company's shares are changing hands for about $148 apiece. Notice that's down meaningfully from the $176.66 highs the stock reached earlier this year after a major clinical milestone. Does this pullback signal that Moderna has little to no upside left, or can the stock still deliver outstanding returns?
Moderna scores a major victory
Moderna's performance looks very different once we zoom out. Over the past five years, the company has lost a little more than 60% of its value. That's because Moderna failed to replicate the success it achieved during the early pandemic years. The company developed one of the leading coronavirus vaccines, but as the pandemic waned and demand for vaccines declined, Moderna's financial results worsened. The market also wasn't convinced that Moderna's mRNA platform could lead to massive commercial success beyond the coronavirus market and infectious diseases more broadly.
Missed Nvidia in 2009? This Rare Signal Is Flashing Again. In 2009, a "Double Down" signal flashed for a little-known chipmaker called Nvidia. For the first time in years, that same "Total Conviction" signal is flashing for a company 1/100th the size of Nvidia. Continue »
But Moderna seems to have put these fears to rest. The company recently posted phase 3 clinical trial results for intismeran autogene, an investigational personalized mRNA-based cancer vaccine. It was being tested in patients with melanoma as a combination therapy with Merck's Keytruda (Moderna is developing intismeran autogene in collaboration with Merck) versus Keytruda monotherapy. Intismeran autogene was associated with significant improvements in recurrence-free survival compared to Keytruda alone.
This clinical win sets up intismeran autogene to earn approval, but that's only part of the story. The vaccine is also being investigated for several other cancers, including lung, bladder, and kidney cancers. There are important implications for Moderna even beyond intismeran autogene. Since no mRNA-based cancer vaccines have ever received approval -- and none had produced such impressive results in a phase 3 clinical trial -- the company's entire pipeline now looks far more valuable than it was before this clinical win.
Moderna has several other mRNA cancer vaccines in various stages of clinical development. We can't guarantee they will all eventually earn approval. In fact, at least some of them will fail. But intismeran autogene's phase 3 success significantly improved the probability of approval of several of Moderna's early stage assets, which explains why the stock soared by more than 100% on the news.
What's next for Moderna?
Moderna had another important milestone this year. The company's mFLUSIVA, a flu vaccine, earned approval. mFLUSIVA performed better than some approved influenza vaccines in phase 3 studies, so it may grab a decent slice of the $8.9 billion flu vaccine market (as of last year, according to some estimates). Further, some analysts estimate that intismeran autogene could generate $5.6 billion in peak revenue, which Moderna will split on a 50/50 basis with Merck.
Moderna should also make more clinical progress over the next five years. Even if some investigational products don't generate much -- or any -- revenue in this period, Moderna's shares could rise on important clinical wins. Still, the bears will point out that the stock is now worth $59.4 billion and has a price-to-sales ratio of 27.5, both of which make it look expensive for a company that currently generates little revenue and is not profitable. Even with that caveat, my view is that Moderna remains an attractive long-term bet.
The company's pipeline is full of highly promising mRNA-based candidates across various therapeutic areas, including fairly challenging targets, that should make progress in the next few years. In the meantime, we should see the company's revenue stabilize over the medium term. Its COVID-19 portfolio will play a smaller role, while new products drive consistent top-line increases. Within five years, Moderna could be a well-established mRNA leader with several approved products under its belt and a rich pipeline of candidates. It may reward patient biotech investors with attractive returns along the way.
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Wall Street Has Cooled on Moderna After Its Stock Jumped Over 5X. But Does the mRNA Leader Have More Room to Run?

Summit Therapeutics SMMT stock climbed 17.3% on Thursday after its Chinese partner Akeso reported positive overall survival (OS) results for ivonescimab in a head-to-head phase III study against Merck’s MRK blockbuster oncology drug, Keytruda (pembrolizumab), in certain patients with non-small cell lung cancer (NSCLC). The data provided fresh clinical validation for SMMT’s lead oncology candidate and increased investor focus on the drug’s potential in the United States and other licensed markets.
Summit Therapeutics is developing ivonescimab in collaboration with Akeso. The company acquired an exclusive license from Akeso in 2022 to develop and market the drug in the United States, Canada, Europe and Japan. SMMT later amended this collaboration agreement in June 2024, expanding its licensing deal to cover Latin America (including Mexico and all countries in Central America, South America and the Caribbean), the Middle East and Africa. Akeso retains the rights to market the drug in China, where the drug is approved for three NSCLC indications. Ivonescimab remains investigational in Summit’s licensed territories.
Akeso’s phase III HARMONi-2 study evaluated ivonescimab monotherapy against MRK’s Keytruda monotherapy in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. In the latest preplanned analysis, Akeso reported that ivonescimab monotherapy achieved a statistically significant improvement in OS versus Keytruda monotherapy, meeting a key secondary endpoint of the HARMONi-2 study. The China-based study had previously demonstrated a statistically significant progression-free survival (PFS) benefit, with an HR of 0.51, across multiple clinical subgroups. Additional details are expected at an upcoming medical conference.
The HARMONi-2 result is particularly relevant because Summit Therapeutics is conducting the global Phase III HARMONi-7 study, including sites in the United States, to evaluate ivonescimab monotherapy versus Merck’s Keytruda monotherapy in patients with previously untreated metastatic NSCLC and high PD-L1 expression. The study is designed to assess both PFS and OS and is currently enrolling patients.
Year to date, SMMT shares have lost 2% compared with the industry’s 0.9% decline.
SMMT’s Progress With Ivonescimab
Summit Therapeutics is currently pursuing U.S. regulatory approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed after treatment with an EGFR-TKI. The submission is based on positive results from the phase III HARMONi study, which evaluated the combination for this indication. The study met one of its two primary endpoints — PFS. Although the study did not meet the OS endpoint, which the FDA had previously identified as a key requirement for filing, the data showed a favorable trend toward OS. The agency is expected to make a decision by Nov. 14, 2026, potentially providing SMMT with an additional regulatory milestone for the candidate in the United States.
Summit Therapeutics is also advancing ivonescimab across other NSCLC indications while expanding the candidate’s development into additional cancer types. The company is conducting HARMONi-3, a global phase III study evaluating ivonescimab plus chemotherapy against MRK’s Keytruda plus chemotherapy as a first-line treatment for metastatic NSCLC. The study comprises separate squamous and non-squamous patient cohorts. Enrollment in the squamous cohort has been completed, with data expected in the second half of 2026, while results from the non-squamous cohort are anticipated in the first half of 2027.
Summit Therapeutics is also evaluating ivonescimab in HARMONi-GI3, a global phase III study for first-line unresectable metastatic colorectal cancer. The study is comparing ivonescimab plus chemotherapy with bevacizumab plus chemotherapy and represents the company’s first clinical development program for ivonescimab outside NSCLC, broadening the candidate’s potential commercial opportunity.
Summit Therapeutics is further expanding ivonescimab into genitourinary oncology through the phase II/III HARMONi-GU1 study, which was initiated in August 2026. The study is evaluating ivonescimab plus enfortumab vedotin against Merck’s Keytruda plus enfortumab vedotin as a first-line treatment for previously untreated locally advanced or metastatic urothelial carcinoma.
Summit Therapeutics PLC Price and Consensus
SMMT’s Zacks Rank and Stocks to Consider
Summit currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are AC Immune ACIU and Aldeyra Therapeutics ALDX, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 6.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 30 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 71.5% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report