Track market-moving stories before they get noisy

 | Source: Wintrust Financial Corporation

ROSEMONT, Ill., Oct. 22, 2026 (GLOBE NEWSWIRE) -- The Board of Directors of Wintrust Financial Corporation (“Wintrust” or the “Company”) (Nasdaq: WTFC) has approved a quarterly cash dividend of $0.55 per share of outstanding common stock. The dividend is payable on November 19, 2026, to shareholders of record as of November 5, 2026.

Additionally, the Company’s Board of Directors approved a cash dividend on outstanding shares of the Company’s 7.875% Fixed-Rate Reset Non-Cumulative Perpetual Preferred Stock, Series F. The dividend is payable on January 15, 2027, to shareholders of record as of January 1, 2027.

About Wintrust

Wintrust is a financial holding company with $76.0 billion in assets whose common stock is traded on the Nasdaq Global Select Market. Guided by its “Different Approach, Better Results®” philosophy, Wintrust offers the sophisticated resources of a large bank while providing a community banking experience to each customer. Wintrust operates more than 200 retail banking locations through 16 community bank subsidiaries in the greater Chicago, southern Wisconsin, west Michigan, northwest Indiana, and southwest Florida market areas. In addition, Wintrust operates various non-bank business units, providing residential mortgage origination, wealth management, commercial and life insurance premium financing, short-term accounts receivable financing/outsourced administrative services to the temporary staffing services industry, and qualified intermediary services for tax-deferred exchanges. For more information, please visit wintrust.com.

Forward-Looking Information

This press release contains forward-looking statements within the meaning of the federal securities laws. Investors are cautioned that such statements are predictions and that actual events or results may differ materially. Wintrust's expected financial results or other plans are subject to a number of risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" and the forward-looking statement disclosure contained in Wintrust's Annual Report on Form 10-K for the most recently ended fiscal year and in Wintrust’s subsequent Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date made and Wintrust undertakes no duty to update the information.

FOR MORE INFORMATION CONTACT:
David A. Dykstra, Vice Chairman & Chief Operating Officer
(847) 939-9000
Amy Yuhn, Executive Vice President, Communications
(847) 939-9591
Website address: www.wintrust.com

 | Source: Highwoods Properties, Inc.

RALEIGH, N.C., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Highwoods Properties, Inc. (NYSE:HIW) announces its Board of Directors has declared a cash dividend of $0.50 per share of common stock for the quarter ended September 30, 2026, which equates to an annualized dividend of $2.00 per share. This quarterly dividend is payable on December 8, 2026 to all holders of record as of November 16, 2026.

The Board also declared a cash dividend of $21.5625 per share of the Company’s 8 5/8% Series A Cumulative Redeemable Preferred Stock. The dividend is payable on November 30, 2026 which is the next regularly scheduled dividend payment date, to all holders of record as of November 16, 2026.

About Highwoods
Highwoods Properties, Inc., headquartered in Raleigh, is a publicly-traded (NYSE:HIW), fully-integrated office real estate investment trust (“REIT”) that owns, develops, acquires, leases and manages properties primarily in the best business districts (BBDs) of Atlanta, Charlotte, Dallas, Nashville, Orlando, Raleigh and Tampa. Our vision is to be a leader in the evolution of commercial real estate for the benefit of our customers, our communities and those who invest with us. Our mission is to create environments and experiences that inspire our teammates and our customers to achieve more together. We are in the work-placemaking business and believe that by creating exceptional environments and experiences, we can deliver greater value to our customers, their teammates and, in turn, our shareholders. For more information about Highwoods, please visit our website at www.highwoods.com.

Contact:Brendan Maiorana Executive Vice President and Chief Financial Officer [email protected] 919-872-4924

, /PRNewswire/ -- Shareholder rights law firm Robbins LLP is investigating Six Flags Entertainment Corporation (NYSE: FUN) to determine whether certain Six Flag's officers and directors violated securities laws and breached fiduciary duties to shareholders. Six Flags operates amusement parks and resort properties in North America.

Why Are We Investigating Six Flags?

On October 13, 2026, the Wall Street Journal published an article, 'Six Flags Closes Several Rides After Georgia Roller-Coaster Death," which stated that the Company "was shutting down similar attractions across its parks after several people were injured." Specifically, police found Hassan Jihad Ibn Kariem, 42 years old, under the Goliath roller coaster at Six Flags Over Georgia just before 4 p.m. Monday. He was unresponsive and not breathing, according to the Cobb County Police Department. Investigators believe Kariem was ejected from the ride and struck other passengers before falling to his death, based on interviews with witnesses and theme-park employees.

Six Flags has recently faced scrutiny over the safety record associated with another of its attractions: the X2 coaster at its Magic Mountain park in Southern California. Multiple lawsuits alleged that the coaster caused serious brain injuries. Six Flags permanently closed that ride last month.

Shares in Six Flags fell approximately 14.4% on October 13, 2026.

What Can FUN Shareholders Do Now?

If you lost money investing in Six Flags Entertainment Corporation, contact Robbins LLP for more information by submitting an inquiry, emailing attorney Aaron Dumas, Jr., or calling (800) 350-6003.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.

Why Robbins LLP?

A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002.  Since our inception, we have obtained over $2 billion for shareholders.

To be notified if a class action against Six Flags Entertainment Corporation settles or to receive free alerts when corporate executives engage in wrongdoing, sign up for Stock Watch today.

Attorney Advertising.  Past results do not guarantee a similar outcome.  

SOURCE Robbins LLP

, /PRNewswire/ -- F.N.B. Corporation (NYSE: FNB) announced its Board of Directors declared a quarterly cash dividend of $0.13 per share on its common stock. The dividend is payable on December 15, 2026, to shareholders of record as of the close of business on December 1, 2026.

About F.N.B. Corporation
F.N.B. Corporation (NYSE: FNB), headquartered in Pittsburgh, Pennsylvania, is a diversified financial services company operating in seven states and the District of Columbia. FNB's market coverage spans several major metropolitan areas including: Pittsburgh, Pennsylvania; Baltimore, Maryland; Cleveland, Ohio; Washington, D.C.; Charlotte, Raleigh, Durham and the Piedmont Triad (Winston-Salem, Greensboro and High Point) in North Carolina; and Charleston, South Carolina. The Company has total assets of $52 billion and more than 355 banking offices throughout Pennsylvania, Ohio, Maryland, West Virginia, North Carolina, South Carolina, Washington, D.C. and Virginia.

FNB provides a full range of commercial banking, consumer banking and wealth management solutions through its subsidiary network which is led by its largest affiliate, First National Bank of Pennsylvania, founded in 1864. Commercial banking solutions include corporate banking, small business banking, investment real estate financing, government banking, business credit, capital markets and equipment financing. The consumer banking segment provides a full line of consumer banking products and services, including deposit products, mortgage lending, consumer lending and a complete suite of mobile and online banking services. FNB's wealth management and advisory services include asset management, private banking and insurance.

The common stock of F.N.B. Corporation trades on the New York Stock Exchange under the symbol "FNB" and is included in Standard & Poor's MidCap 400 Index with the Global Industry Classification Standard (GICS) Regional Banks Sub-Industry Index. Customers, shareholders and investors can learn more about this regional financial institution by visiting the F.N.B. Corporation website at www.fnbcorporation.com. 

SOURCE F.N.B. Corporation

-

Joint research effort seeks to improve abuse potential assessment tools to support drug development and public health decision-making

WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) and Labcorp for developing sensitive screening tools to quantify and rank the abuse potential of new drugs, including abuse-deterrent formulations (ADFs) and emerging drugs of abuse. The agreement establishes a joint research framework to enhance objective, standardized metrics for quantifying abuse potential in preclinical models which may inform regulatory assessments of abuse potential under the Controlled Substances Act (CSA).

Abuse potential assessments are vital components of the safety evaluation of central nervous system-active compounds and are relied upon by FDA and the Drug Enforcement Administration for scheduling control measures.

Share “Assessing abuse potential is essential for identifying risks and ensuring the safety of new drugs,” said Dr. Namandjé N. Bumpus, Chief Science and Innovation Officer, Charles River. “This collaboration will improve public health safeguards and ultimately amplify our shared efforts to protect patients and communities.”

Evaluating Abuse Potential
Abuse potential assessments are vital components of the safety evaluation of central nervous system-active compounds and are relied upon by FDA and the Drug Enforcement Administration for scheduling control measures.

Enhancing objective, reproducible methods to assess abuse potential is important for advancing regulatory science and supporting evidence-based decision-making. This collaboration will help evaluate approaches that could improve the consistency and sensitivity of abuse potential assessments, ultimately contributing to efforts to protect public health.

Charles River has extensive expertise in assessing abuse potential, having conducted over 100 abuse potential studies and contributed to assessments of the abuse potential of 15 FDA-approved products. As part of its participation in the collaboration, Charles River will leverage behavioral economic models of supply and demand to analyze self-administration data. These models assess the relative reinforcing properties of substances, helping researchers evaluate abuse potential and compare it with that of known drugs of abuse. A recent behavioral economics pilot conducted at Charles River’s Mattawan site provided preliminary proof-of-concept data that demonstrated the promise of this approach.

The collaboration aims to improve sensitivity, accuracy, and consistency across laboratories, ultimately enhancing public health by more reliably and effectively assessing the abuse potential of new drugs.

About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

More News From Charles River Laboratories International, Inc.

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San Francisco, California--(Newsfile Corp. - October 22, 2026) - Hims & Hers Health, Inc. (NYSE: HIMS) and certain company executives now face a securities class action lawsuit stemming from the FTC's sweeping federal complaint against the company in which the Commission accuses Hims of serious business misconduct.

Hagens Berman, which is actively investigating the alleged claims, encourages HIMS investors who suffered substantial losses to submit your losses now.

Class Period: Aug. 4, 2025 - July 29, 2026
Lead Plaintiff Deadline: Nov. 2, 2026
Visit Hims Investigation Page: www.hbsslaw.com/hims
Direct Contact Email: [email protected]
Firm Telephone: 844-916-0895
Video:

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Hims & Hers Health ($HIMS) Securities Class Action

The lawsuit is focused on the propriety of Hims' repeated assurances that "[w]e have developed and maintain policies and procedures with respect to health information and personal information that we use or disclose in connection with our operations, including the adoption of administrative, physical, and technical safeguards to protect such information."

The complaint alleges that Hims: (1) shared consumers' health information with third-party advertising platforms; (2) charges consumers for prescriptions almost immediately after they submit intake forms, despite telling them that they will be able to consult with a medical provider to find a treatment that is "right for them[;]" and (3) as a result, would be subject to heightened regulatory scrutiny and likely to incur fees and penalties.

What Drove the $HIMS July 29, 2026 Stock Crash? The FTC and State Lawsuit Breakdown

The securities class action cites the July 29, 2026 federal complaint filed against Hims by the FTC-alongside co-plaintiffs the State of Utah and the County of Los Angeles (representing California).

After an extensive investigation by the Commission, it contends that Hims engaged in:

Deceptive Health Data Sharing: Despite extensive marketing campaigns emphasizing strict privacy, discreet telehealth consultations, and data protection, the complaint alleges that Hims surreptitiously shared sensitive user medical conditions and personal health data with third-party advertising giants, including Meta Platforms (Facebook) and Snap, via embedded tracking pixels and customer list matching. Subscription Billing & Cancellation Barriers (ROSCA Violations): The lawsuit accuses Hims of violating the Restore Online Shoppers' Confidence Act (ROSCA) by enrolling consumers in recurring subscription models without informed consent. According to regulators, consumers were billed for prescriptions almost immediately upon completing an intake form-long before receiving any consultation with a medical provider-while facing dark patterns and hidden cancellation options designed to prevent subscription termination.The market swiftly reacted, sending the price of Hims shares down $4.32 (-14.7%) and erasing over $970 million from the company's market capitalization in a single day.

"We're focused on whether Hims may have intentionally misled investors about its business practices, including the adequacy of its internal controls, and financial ramifications of the alleged misconduct," said Reed Kathrein, the Hagens Berman partner leading the firm's investigation.

If you invested in HIMS and have substantial losses, or have knowledge that will assist the firm's investigation, submit your losses now »

Whistleblowers: Persons with non-public information regarding HIMS should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].

# # #

About Hagens Berman
Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.

Attorney Advertising. Prior results do not guarantee a similar outcome in any future case.

Contact: Hagens Berman, Reed Kathrein, 715 Hearst Avenue, Suite 300, Berkeley, CA 94710, 844-916-0895, [email protected]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/320488

Source: Hagens Berman Sobol Shapiro LLP

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Minneapolis, MN, Oct. 22, 2026 (GLOBE NEWSWIRE) -- Sezzle Inc. (NASDAQ: SEZL) (Sezzle or Company) today announced that it has filed an application with the Office of the Comptroller of the Currency (OCC) to charter a national bank, Sezzle Bank, N.A. and applied to the Federal Deposit Insurance Corporation (FDIC) for deposit insurance.

If approved, Sezzle Bank would offer a broad range of banking products and services, including FDIC-insured deposit accounts, checking and savings accounts, and credit products. Sezzle Bank would focus on digitally native consumers, including those new to credit, and who tend to avoid using more traditional credit products such as credit cards, to provide a choice of lending options.

As a national bank, Sezzle Bank would be subject to ongoing supervision and examination by the OCC, including for safety and soundness, consumer compliance, Bank Secrecy Act/anti-money laundering, and fair lending. Sezzle will apply to become a bank holding company subject to consolidated supervision by the Board of Governors of the Federal Reserve System.

"Applying for a national bank charter reflects our commitment to operating under the highest standards of federal oversight," said Charlie Youakim, Chief Executive Officer and Executive Chairman of Sezzle. "A charter would allow us to offer a broader set of banking products to people who prefer BNPL and digitally native banking products, with the same federal supervision that applies to every national bank."

The filing begins Sezzle's formal charter application process. There is no change for Sezzle customers at this time, and Sezzle will continue working with its existing lending partners. Regulatory approvals are not guaranteed, and Sezzle will provide updates as appropriate.

To learn more about Sezzle, visit sezzle.com. 

About Sezzle Inc.

Sezzle is a forward-thinking fintech company committed to financially empowering the next generation. Designed to support users throughout every stage of their financial journey, Sezzle’s all-in-one app enables users to shop, earn, and learn in a seamless experience. By offering point-of-sale financing and digital payment services, Sezzle enhances purchasing power while connecting millions of consumers with its global network of merchants. Centered on transparency, inclusivity, and ease of use, Sezzle empowers consumers to manage spending responsibly and build lasting financial independence.

For additional assets and news on Sezzle please visit https://sezzle.com/news/.

Follow Sezzle on social media: LinkedIn | Instagram | X 

Sezzle Media Contact:

Erin Foran

Tel: (651) 403-2184

Email: [email protected]

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, are forward-looking statements, including statements regarding the timing and the ability of Sezzle to obtain approval for a national bank charter, Sezzle's plans and strategic initiatives, including planned business activities and target market of Sezzle Bank, Sezzle's intention to submit the applications discussed in this release and the timing and success thereof, and the ability of Sezzle to realize the anticipated benefits of these activities. 

Forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," "will," "believe," "estimate," "forecast," "goal," "project," and other words of similar meaning. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the possibility that the national bank charter application, or other expected applications discussed in the release may not be approved timely, if at all; the uncertain nature of the impact that a national bank charter may have on Sezzle's business; impact of the “buy-now, pay-later” (“BNPL”) industry becoming subject to increased regulatory scrutiny; impact of operating in a highly competitive industry; impact of macro-economic conditions on consumer spending; our ability to increase our merchant network, our base of consumers and underlying merchant sales (UMS); our ability to effectively manage growth, sustain our growth rate and maintain our market share; our ability to meet additional capital requirements; impact of exposure to consumer bad debts and insolvency of merchants; impact of the integration, support and prominent presentation of our platform by our merchants; impact of any data security breaches, cyberattacks, employee or other internal misconduct, malware, phishing or ransomware, physical security breaches, natural disasters, or similar disruptions; impact of key vendors or merchants failing to comply with legal or regulatory requirements or to provide various services that are important to our operations; impact of the loss of key partners and merchant relationships; our ability to retain employees and recruit additional employees; and impact of the costs of complying with various laws and regulations applicable to the BNPL industry and financial institutions in the United States. The Company cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read the Company's filings with the Securities and Exchange Commission, available at www.sec.gov, for a discussion of these and other risks and uncertainties, including but not limited to those risks described in “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on February 26, 2026. The forward-looking statements in this press release speak only as of the date of this document, and the Company undertakes no obligation to update or revise any of these statements. The Company's business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

SpaceX Corp (NASDAQ:SPCX) is moving closer to its next major growth milestone, with an ambitious revenue outlook and a crucial Starship recovery test ahead prompting Bank of America to raise its price target to $275 following a third-quarter beat. 

The bank said management’s growth ambitions are becoming more achievable than previously expected, prompting it to bring forward revenue estimates for the coming years, including as early as 2027. 

Bank of America also drew a comparison with the 19th-century railroad industry, arguing that both businesses are built around dramatically reducing transportation costs. 

SpaceX remains on track to reach $100 billion in annualized revenue by the end of 2026, a target established last quarter. 

Management now expects first-quarter 2027 revenue of $33 billion to $37 billion, well above the roughly $22 billion anticipated by analysts. 

The company also forecast annual recurring revenue of $500 billion to $1 trillion by the end of 2027, bringing forward its previous target of $1 trillion from 2030. 

Compute spending set to accelerate  Capital spending on orbital and terrestrial computing infrastructure is expected to increase faster than analysts had anticipated. 

Bank of America expects capital expenditure to reach $35 billion to $40 billion in the fourth quarter, up from $19 billion in the third quarter. 

The bank said SpaceX has sufficient liquidity to fund its investment program for the next few quarters, but expects the company to tap debt markets as spending increases. 

It added that rising value per watt of computing capacity could support rapid payback periods, potentially beginning next year. 

Starship launches offer next catalyst  SpaceX completed 35 launches in the third quarter, while Starship continued to progress towards full reusability and expanded satellite deployment capacity. 

Flight 14 marked Starship’s first revenue-generating mission, demonstrating orbital insertion and deploying 26 operational Starlink V3 satellites. 

Flight 15 is expected next month and will target the recovery of both the booster and the spacecraft, a milestone Bank of America considers the program’s next major catalyst. 

Successful execution could pave the way for weekly Starship launches in the first half of 2027, with launch frequency expected to accelerate in the second half. 

Bank of America said progress towards that schedule would reduce execution risks and expand SpaceX’s capacity to deploy Starlink satellites. 

For nearly two decades Apple (AAPL.O) has made only small changes to the iPhone, its money machine. That changes ​on Friday when Apple starts selling its first folding phone, iPhone Duo, betting that the device can do for the small ‌foldables market what the iPhone did for smartphones.

Its reception could prove an early test for new Apple CEO John Ternus, the former hardware chief who unveiled iPhone Duo barely a week after taking charge in September.

It could also have large implications for a niche category in which rivals such as Samsung Electronics (005930.KS) and Huawei Technologies have sold premium offerings ​for years.

Within minutes of pre-orders opening last Friday, Apple's estimated delivery dates for the Duo had slipped to late January as demand outpaced ​supply. The company called the response from customers "nothing short of extraordinary."

MIXED REVIEWS
Early reviews have praised the $1,999 Duo's premium design ⁠as well as its sturdy and barely visible hinge, a major feat for the phones whose prominent creased screen has long been a major drawback ​and potential deterrent to buyers.

But reviewers have also said that camera compromises including the absence of a telephoto lens and third-party apps that still need to ​be reworked for the new display size could disappoint some buyers. They have noted that iPhone Duo in its smaller, folded state is less handy for the litany of quick tasks that most users carry out each day on standard iPhones, leading several prominent reviewers to recommend against the Duo for many Apple customers.

"It's been a lot of fun ​trying the Duo out for a week, but it feels like I've gotten to use an extraordinarily polished prototype — not a finished product that I'd want ​to buy and carry," longtime Apple commentator John Gruber, the author of the blog Daring Fireball, wrote in a review.

Tech commentator Marques Brownlee, popularly known as MKBHD, said ‌in a ⁠YouTube review that "if you're just a regular person who doesn't do much more than texting, social media and browsing here and there, then it is probably a no. But if the $2,000 doesn't mean much to you, and you like the idea, after the learning curve and getting used to not having facial identification, it is a really fun phone."

TOUGH TO FIND
The limited supplies could disappoint Apple fans lining up in front of stores to buy the Duo. Apple ​told Reuters that walk-in availability would vary ​by country, with limited stocks ⁠in the US, Australia, Canada, Mexico and much of Britain and Europe. In China, France, Hong Kong, India and Japan, units would be available only for customers who had ordered online.

In the China-governed territory of Macau, where the iPhone ​Duo will be available for walk-in customers only, fans already started lining up hours in advance, social media ​posts and media reports ⁠showed.

"Foldables have been an established category for years, but adoption has remained relatively limited compared with conventional smartphones. Apple's entry could bring the format to a much broader audience," said Francisco Jeronimo, vice president at market research firm IDC.

IDC expects Apple will take 44% of the foldable value in 2026 on 31% of foldable ⁠units. By ​2027, it will become the market leader in the category both in value and units ​shipped, according to the firm.

"Apple has made a convincing case for this form factor," Jeronimo said after spending a week with the Duo.

"Now comes the next test: turning excitement into availability, adoption ​and a lasting new chapter for the smartphone market," Jeronimo added.

Key Takeaways Rapid Muse growth proves premium monetizable engagement.Post-earnings test of the 10-week MA offers an attractive entry.With a 23x P/E, Meta is fundamentally undervalued. Early Meta Muse Data is Extremely Bullish“Muse,” Meta Platform’s ((META - Free Report) ) agentic AI offering, debuted in early September. In just over a month, Muse shot to the top of the Apple App Store rankings and became the fastest-growing consumer app in history outside OpenAI’s ChatGPT. Beyond the rapid user growth, the latest data from Meta’s earnings call revealed that each customer is more valuable than a typical AI customer. CEO Mark Zuckerberg explained:

"The most common use case for Muse is shopping. With more than a quarter of people who are using Muse engaging in this with an average purchase size of over $200, Plaid told us that they hadn't seen activity like they're seeing with their connector on any other service before. And in the first week, we had to work with Stripe to raise credit limits since the volumes were above what any of us expected. Beyond shopping, the most common connectors are for personal productivity and connecting Muse to your other services like email and calendar."

In other words, Muse users are premium, making it easier for Meta to monetize in the future.

Meta Retreats to the 10-week Moving AverageMost amateur investors focus too much on short term time frames and suffer from recency bias from the latest price movements. Conversely, seasoned investors understand the value of analyzing higher time-frame charts (like weekly charts) to filter out the noise and size up the overall trend.

Although Meta dropped ~5% Thursday after its earnings, the overall price trend remains firmly higher. From late July to late September, Meta shares ripped from ~$524 to $780 in a straight line. Before earnings, shares digested the move and traded sideways. However, after earnings, Meta shares tagged the 10-week moving average for the first time since the breakout. Historically, such pullbacks are high-probability buy-the-dip opportunities for investors.

Image Source: TradingView

Meta is Extremely CheapWith a P/E ratio of just 23x, Meta is the cheapest “Mag 7” name.

Image Source: Zacks Investment Research

Meta’s Top-Line Growth is Robust Zacks Consensus Estimates suggest that Meta’s revenues will grow at 20% or more through next year. Considering the robust double-digit growth and reasonable valuation, Meta is sure to attract growth-at-a-reasonable price (GARP) investors.

Image Source: Zacks Investment Research

AI Impact on Ad RevenuesWhile Muse garners the most attention for Meta’s AI efforts, its in-house AI optimization efforts are bearing fruit. In Q2, Family of Apps revenue rose 28% year over year to $60.4 billion as ad impressions increased 14% and average price per ad increased 12%.

Bottom Line

Early data confirms rapid adoption and strong monetization potential for its Muse AI platform. Meta Platforms continues to prove its leadership in agentic AI. Combined with robust top-line growth, double-digit gains in digital advertising revenue, and a highly attractive GARP valuation of just 23x earnings, the recent post-earnings dip to the 10-week moving average presents a compelling, high-probability entry point for long-term investors.

E-commerce and cloud giant Amazon AMZN released new software to simplify adoption of its Trainium AI chips, while shares traded at $252.31, down 3.83%, at 11:55 a.m. ET Thursday. The pitch is straightforward: make switching easier, then turn that convenience into paying workloads. The valuation chart puts the stock just 0.11% above its $252.04 GF Value estimate, suggesting little discount against that benchmark despite the decline.

AWS Neuron 2.33 brings TorchNeuron into public beta, letting developers run standard PyTorch models on Trainium2 and Trainium3. It also introduces Neuron Observer, designed to flag chip health problems in under a second. According to Reuters, an Amazon chip executive said more than 30 early customers were already using TorchNeuron. That gives Amazon an initial adoption base. Sustained commercial use is the next test.

The financial opportunity goes beyond selling more computing capacity. Easier migration could help Amazon steer more AI spending toward its own chips and capture more of the economics. Reuters reported that AWS second-quarter revenue climbed 37% to $42.2 billion, giving the software push a substantial business to build on. Now Amazon needs those easier first steps to translate into recurring workloads, stronger utilization and profitable growth.

SummaryNvidia Corporation remains a Strong Buy, with a $447 price target (~101% upside), driven by its transformation into the AI economy’s central infrastructure and governance provider.NVDA’s strategic moves—Hugging Face acquisition, BlueField-4 agentic governance, NVLink Fusion, and DSX energy orchestration—solidify its moat and recurring-token-yield economics.By financializing AI GPUs and forming insurance-backed asset classes, NVDA mitigates CapEx risk and secures liquidity from neocloud investments and a $150B buyback.Key NVDA forward risks include insurance market shifts, architectural disruption from competitors, and potential geopolitical fragmentation of AI tech standards. imaginima/E+ via Getty Images

In my last article, I marked a Strong Buy rating on Nvidia Corporation (NVDA) stock. At that time, my point was that Nvidia’s business is shifting into being an "almost" financial AI utility provider. On a forward basis, through

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Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

Netflix Subscribers Keep Paying Despite Weaker Viewing. Deutsche Bank Sees a Buying Opportunity

Summary

Despite weaker U.S. viewing trends and advertising delays, Netflix continues to grow revenue and retain subscribers, supporting a top analyst's $93 price target

Netflix NFLX continues to retain subscribers despite weaker U.S. viewing trends, giving Deutsche Bank a reason to stay positive after the streaming company's latest earnings report.

Analyst Bryan Kraft maintained a Buy rating and $93 price target, even as Netflix shares fell 5.3% in Wednesday trading after the company reduced its 2026 advertising revenue forecast to $2.7 billion from about $3 billion. Netflix attributed the reduction to delays in rolling out advertising features and integrating systems with advertisers.

Netflix's third-quarter revenue increased 11.8% year over year to $12.87 billion, while operating income rose 37% to $4.46 billion. The company said cancellations improved from a year earlier in every region, including the United States, despite subscription price increases.

International engagement offered another positive signal. Viewing hours in India climbed 24% during the quarter, with local revenue increasing about 18% after currency adjustments. Kraft believes softer U.S. viewing may reflect a weaker content lineup compared with last year rather than a lasting problem.

Netflix expects 2026 revenue of $51.1 billion, up about 13%, and plans to expand its advertising-supported subscription tier into 15 additional countries in 2027.

Netflix stock rose 3% Thursday morning.

Disclosures
I/we have no positions in any stocks mentioned, and have no plans to buy any new positions in the stocks mentioned within the next 72 hours.

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Visa Inc (NYSE:V, XETRA:3V64) and Mastercard Inc (NYSE:MA) could generate a growing stream of revenue from payment tokenization as digital transactions expand and card networks charge for technology that helps secure payments and reduce fraud, according to UBS. 

Analysts estimated that tokenization-related revenue could contribute a low-single-digit percentage to total net revenue growth at both companies over the medium term, with a low-to-mid-single-digit percentage contribution to growth in their value-added services businesses. 

The analysts estimated Visa's contribution is currently moderately higher than Mastercard's, partly reflecting pricing changes Visa has recently introduced or announced. 

Tokenization replaces sensitive card details with unique digital identifiers, allowing payments to be processed without exposing the underlying card number. The technology is used across eCommerce, mobile wallets and stored payment credentials, with potential applications in emerging areas such as agentic commerce, where artificial intelligence systems initiate transactions on behalf of consumers. 

UBS said the card networks are increasingly monetizing tokenization through dedicated fees, pricing structures that favor tokenized transactions and broader digital services that incorporate token-related capabilities. 

The resulting revenue growth reflects a combination of rising card-not-present transaction volumes, greater token adoption within those transactions and pricing for the services provided. 

Many tokenization-related fees are reported within Visa's value-added services business and Mastercard's value-added services and solutions segment, although some revenue may be recognized within their core payments network businesses. 

Pricing opportunities ahead 

UBS sees scope for Visa and Mastercard to increase tokenization-related pricing as their product offerings develop and become more valuable in preventing fraud and enabling new forms of digital commerce. 

The bank's analysis includes fees already implemented or announced by the companies, as well as publicly disclosed future pricing changes. It therefore views its estimates as a conservative starting point, with additional fees or pricing increases representing potential upside. 

Visa has introduced or announced several tokenization-related fees that Mastercard has not, including fees for tokenized card-present transactions in the US and plans to expand its Digital Commerce Service Fee into Europe in 2027. 

Visa has also announced a 2027 increase to its Digital Commerce Service Fee, according to UBS. 

The analysts cautioned that rebates and incentives offered to business partners could reduce the net revenue ultimately generated from tokenization compared with the amounts implied by their framework. 

UBS described its estimates as an initial framework that may be refined as the companies provide more disclosure or pricing details. The analysis focuses specifically on the monetization of tokenization and related services, rather than attempting to capture all pricing changes or transaction-mix effects across the two payment networks. 

The findings suggest tokenization could become a more meaningful contributor to growth for both companies as digital payments expand, while providing an additional avenue for monetization beyond transaction volumes alone. 

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Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (NASDAQ: MRNA) today announced detailed positive recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) results from the Phase 3 INTerpath-001 trial evaluating intismeran autogene (intismeran; V940 or mRNA-4157), a novel investigational mRNA-based individualized neoantigen therapy (INT) being jointly developed by Merck and Moderna, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as adjuvant treatment for patients with completely resected stage IIB-IV melanoma. These late-breaking results will be presented for the first time during Presidential Symposium I at the European Society for Medical Oncology (ESMO) Congress 2026 (Presentation #LBA1), were selected for an official ESMO Press Briefing and have been accepted for publication in The New England Journal of Medicine.

At the primary pre-specified analysis (intention-to-treat), after a median follow-up of 24.6 months, intismeran in combination with KEYTRUDA significantly reduced the risk of recurrence or death by 42% (HR=0.58 [95% CI, 0.45–0.75]; two-sided p<0.001). Intismeran plus KEYTRUDA also significantly reduced the risk of distant metastasis or death by 38% (HR=0.62 [95% CI, 0.45–0.85]; two-sided p=0.002) compared to KEYTRUDA alone. The improvements observed in RFS and DMFS were generally consistent across pre-specified patient subgroups. Overall survival (OS) data are not yet mature, but a favorable trend in OS with intismeran plus KEYTRUDA has been observed. The study remains ongoing to further evaluate OS and other key endpoints. The safety profile of intismeran plus KEYTRUDA was generally consistent with previously reported studies of the combination, and no new safety signals were observed. Based on these data, we are engaging with regulatory authorities.

The efficacy of the intismeran immunization plus KEYTRUDA in the first six months was comparable with KEYTRUDA alone for risk of recurrence or death (HR=0.99 [95% CI, 0.66–1.49]) and risk of distant metastasis or death (HR=1.01 [95% CI, 0.58–1.79]). At six months, following the intismeran immunization regimen, a pre-specified sensitivity analysis of the primary endpoint showed the addition of intismeran plus KEYTRUDA reduced the risk of recurrence or death by 58% (HR=0.42 [95% CI, 0.30–0.58]) and reduced the risk of distant metastasis or death by half (HR=0.50 [95% CI, 0.34–0.73]) compared to KEYTRUDA alone.

In a pre-specified sensitivity analysis of the modified intent-to-treat (mITT) population, which excluded participants who did not receive at least one dose of intismeran or placebo as planned, intismeran plus KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.51 [95% CI, 0.39–0.67]) and the risk of distant metastasis or death by 45% (HR=0.55 [95% CI, 0.40–0.77]) compared to KEYTRUDA alone.

“The transformative INTerpath-001 results have the potential to make a foundational shift in how we treat patients with earlier-stage melanoma in the adjuvant setting,” said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia, Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney. “For decades, cancer treatment has largely been defined by where a tumor originates in the body. The INTerpath-001 findings support a fundamentally new and individualized approach to treating resected melanoma in the adjuvant setting, one that tailors treatment to the unique mutational signature of a patient’s tumor to enhance an anti-tumor immune response. While these results are in patients with completely resected stage IIB-IV melanoma, they provide valuable insights and will help inform our understanding of intismeran as clinical research continues into other tumor types and across settings.”

“INTerpath-001 is the first Phase 3 study to demonstrate a clinically meaningful improvement in RFS and DMFS over standard-of-care KEYTRUDA in patients with resected melanoma, setting a new benchmark in the adjuvant setting and representing one of the most significant advances in melanoma treatment since the advent of immunotherapy,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “These results, building on the body of evidence from the Phase 2b study, strengthen our confidence in the curative potential of intismeran autogene when given in combination with KEYTRUDA. Importantly, these data suggest that, by intervening earlier, this approach may offer a tangible opportunity to change the trajectory of a patient's cancer.”

“From the beginning, we believed mRNA technology could make it possible to develop cancer treatments uniquely matched to each patient’s tumor. The INTerpath-001 results mark a defining moment for that vision and show what’s possible when we rethink how medicines are made,” said Stéphane Bancel, Chief Executive Officer of Moderna. “These results reinforce our conviction that mRNA has the potential to fundamentally change how we treat cancer.”

Merck and Moderna are advancing the robust INTerpath clinical development program evaluating the safety and efficacy of intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types and stages of disease, including three ongoing Phase 3 trials in non-small cell lung cancer (NSCLC). Additional clinical studies include the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial in adjuvant melanoma and a Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma (Abstract #3151P), perioperative gastric carcinoma and perioperative NSCLC.

The results from INTerpath-001 build on previously reported Phase 2b results for intismeran in combination with KEYTRUDA from the KEYNOTE-942/mRNA-4157-P201 trial, including the five-year follow-up data presented at the 2026 ASCO Annual Meeting.

Study design and additional data from INTerpath-001

INTerpath-001 is a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial (ClinicalTrials.gov, NCT05933577) evaluating the safety and efficacy of intismeran in combination with KEYTRUDA compared to KEYTRUDA alone in patients with high-risk (stage IIB-IV) resected cutaneous melanoma. The trial enrolled 1,137 patients who, following complete surgical resection, were randomized 2:1 to receive intismeran (1 mg every three weeks for up to nine doses) and KEYTRUDA (400 mg every six weeks up to nine cycles [for approximately one year]) compared to placebo plus KEYTRUDA for approximately one year until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever was sooner.

The primary endpoint is RFS, defined as the time from randomization to any disease recurrence (local, locoregional, regional or distant) as assessed by the investigator, or death due to any cause. Key secondary endpoints include DMFS, OS, safety, tolerability and quality of life.

In the ITT population, the two-year RFS rate was 82.2% (95% CI, 79.3%–84.8%) for intismeran plus KEYTRUDA compared to 70.0% (95% CI, 65.0%–74.5%) for KEYTRUDA alone. Median RFS was not reached (NR) (95% CI, not estimable [NE]–NE) for either arm. Additionally, the two-year DMFS rate was 88.5% (95% CI, 86.0%–90.6%) for intismeran plus KEYTRUDA compared to 80.2% (95% CI, 75.6%–84.0%) for KEYTRUDA alone. Median DMFS was NR (95% CI, NE–NE) for either arm.

Treatment-related adverse events (TRAEs) occurred in 95.8% (723 of 755 patients) receiving intismeran plus KEYTRUDA and 90.0% (342 of 380 patients) receiving KEYTRUDA alone. Grade 3–5 TRAEs occurred in 14.2% (n=107) versus 13.4% (n=51) of patients, respectively. The most common adverse events in the intismeran plus KEYTRUDA arm were pyrexia (52.2%), injection site pain (51.0%) and fatigue (38.5%).

About intismeran autogene

Intismeran autogene (intismeran; V940 or mRNA-4157) is a novel, potential first-in-class investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna. Intismeran is designed and produced using a patient’s tumor sample to identify the unique mutational signature of their cancer and generate an anti-tumor immune response. Information derived from the patient’s tumor and normal DNA is used to create an individualized treatment design, or “blueprint,” informed by selected neoantigens unique to that patient’s cancer. Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens. Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Individualized neoantigen therapies are designed to train and activate an anti-tumor immune response based on the unique mutational signature of a patient’s tumor.

About melanoma

Melanoma, one of the deadliest forms of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 338,000 new cases diagnosed worldwide in 2024. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026 alone. Despite advances in treatment, patients with resected melanoma remain at risk of disease recurrence, which most often occurs within the first two years following surgery. Disease recurrence can be metastatic as well as localized, with more than half of patients who experience recurrence developing one or more distant metastases. Distant metastases can spread to critical organs, including the lung, liver and brain, and are associated with substantially worse outcomes, underscoring the continued need for treatment approaches that can help reduce the risk of recurrence and the risk of local and distant metastasis.

About Merck’s research in melanoma

Merck is committed to delivering meaningful advances for patients with melanoma and to continuing research in skin cancers through a broad clinical development program across investigational and approved medicines. KEYTRUDA has been established as an important treatment option for the adjuvant treatment of patients with resected Stage IIB, IIC, or III melanoma based on results of KEYNOTE-054 and KEYNOTE-716. KEYTRUDA is also approved worldwide for the treatment of patients with unresectable or metastatic melanoma. Leveraging a decade of melanoma clinical trials, Merck continues to explore both innovative treatment approaches, including investigational individualized neoantigen therapies, and novel KEYTRUDA combinations with the goal of further improving long‑term outcomes for people living with melanoma.

About Merck’s early-stage cancer clinical program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected Indications in the U.S. for KEYTRUDA® (pembrolizumab)

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection.

See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.

Selected Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection; Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap syndrome, reported as the co-occurrence of either two or all three adverse reactions.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between anti–PD-1/PD-L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using anti–PD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an anti–PD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, when KEYTRUDA was administered as a single agent to patients with stage III melanoma, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (≥1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (≥20%) with KEYTRUDA was diarrhea (28%). In KEYNOTE-716, when KEYTRUDA was administered as a single agent to patients with stage IIB or IIC melanoma, adverse reactions occurring in patients with stage IIB or IIC melanoma were similar to those occurring in 1011 patients with stage III melanoma from KEYNOTE-054.

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (≥20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

In KEYNOTE-671, adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single-agent adjuvant treatment, were generally similar to those occurring in patients in other clinical trials across tumor types receiving KEYTRUDA in combination with chemotherapy.

The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy or chemoradiotherapy were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, pyrexia, alopecia, peripheral neuropathy, mucosal inflammation, stomatitis, headache, weight loss, abdominal pain, arthralgia, myalgia, insomnia, palmar-plantar erythrodysesthesia, urinary tract infection, hypothyroidism, radiation skin injury, dysphagia, dry mouth, and musculoskeletal pain.

In the neoadjuvant phase of KEYNOTE-671, when KEYTRUDA was administered in combination with platinum-containing chemotherapy as neoadjuvant treatment, serious adverse reactions occurred in 34% of 396 patients. The most frequent (≥2%) serious adverse reactions were pneumonia (4.8%), venous thromboembolism (3.3%), and anemia (2%). Fatal adverse reactions occurred in 1.3% of patients, including death due to unknown cause (0.8%), sepsis (0.3%), and immune-mediated lung disease (0.3%). Permanent discontinuation of any study drug due to an adverse reaction occurred in 18% of patients who received KEYTRUDA in combination with platinum-containing chemotherapy; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of any study drug were acute kidney injury (1.8%), interstitial lung disease (1.8%), anemia (1.5%), neutropenia (1.5%), and pneumonia (1.3%).

Of the KEYTRUDA-treated patients who received neoadjuvant treatment, 6% of 396 patients did not receive surgery due to adverse reactions. The most frequent (≥1%) adverse reaction that led to cancellation of surgery in the KEYTRUDA arm was interstitial lung disease (1%).

In the adjuvant phase of KEYNOTE-671, when KEYTRUDA was administered as a single agent as adjuvant treatment, serious adverse reactions occurred in 14% of 290 patients. The most frequent serious adverse reaction was pneumonia (3.4%). One fatal adverse reaction of pulmonary hemorrhage occurred. Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 12% of patients who received KEYTRUDA as a single agent, given as adjuvant treatment; the most frequent adverse reactions (≥1%) that led to permanent discontinuation of KEYTRUDA were diarrhea (1.7%), interstitial lung disease (1.4%), increased aspartate aminotransferase (1%), and musculoskeletal pain (1%).

Adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC receiving KEYTRUDA as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.

Adverse reactions observed in KEYNOTE-483 were generally similar to those occurring in other patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy.

In KEYNOTE-689, the most common adverse reactions (≥20%) in patients receiving KEYTRUDA were stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), dysphagia (29%), constipation (27%), hypothyroidism (26%), nausea (24%), rash (22%), dry mouth (22%), diarrhea (22%), and musculoskeletal pain (22%).

In the neoadjuvant phase of KEYNOTE-689, of the 361 patients who received at least one dose of single agent KEYTRUDA, 11% experienced serious adverse reactions. Serious adverse reactions that occurred in more than one patient were pneumonia (1.4%), tumor hemorrhage (0.8%), dysphagia (0.6%), immune-mediated hepatitis (0.6%), cellulitis (0.6%), and dyspnea (0.6%). Fatal adverse reactions occurred in 1.1% of patients, including respiratory failure, clostridium infection, septic shock, and myocardial infarction (one patient each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 2.8% of patients who received KEYTRUDA as neoadjuvant treatment. The most frequent adverse reaction which resulted in permanent discontinuation of neoadjuvant KEYTRUDA in more than one patient was arthralgia (0.6%).

Of the 361 patients who received KEYTRUDA as neoadjuvant treatment, 11% did not receive surgery. Surgical cancellation on the KEYTRUDA arm was due to disease progression in 4%, patient decision in 3%, adverse reactions in 1.4%, physician’s decision in 1.1%, unresectable tumor in 0.6%, loss of follow-up in 0.3%, and use of non-study anti-cancer therapy in 0.3%.

Of the 323 KEYTRUDA-treated patients who received surgery following the neoadjuvant phase, 1.2% experienced delay of surgery (defined as on-study surgery occurring ≥9 weeks after initiation of neoadjuvant KEYTRUDA) due to adverse reactions, and 2.8% did not receive adjuvant treatment due to adverse reactions.

In the adjuvant phase of KEYNOTE-689, of the 255 patients who received at least one dose of KEYTRUDA, 38% experienced serious adverse reactions. The most frequent serious adverse reactions reported in ≥1% of KEYTRUDA-treated patients were pneumonia (2.7%), pyrexia (2.4%), stomatitis (2.4%), acute kidney injury (2.0%), pneumonitis (1.6%), COVID-19 (1.2%), death not otherwise specified (1.2%), diarrhea (1.2%), dysphagia (1.2%), gastrostomy tube site complication (1.2%), and immune-mediated hepatitis (1.2%). Fatal adverse reactions occurred in 5% of patients, including death not otherwise specified (1.2%), acute renal failure (0.4%), hypercalcemia (0.4%), pulmonary hemorrhage (0.4%), dysphagia/malnutrition (0.4%), mesenteric thrombosis (0.4%), sepsis (0.4%), pneumonia (0.4%), COVID-19 (0.4%), respiratory failure (0.4%), cardiovascular disorder (0.4%), and gastrointestinal hemorrhage (0.4%). Permanent discontinuation of adjuvant KEYTRUDA due to an adverse reaction occurred in 17% of patients. The most frequent (≥1%) adverse reactions that led to permanent discontinuation of adjuvant KEYTRUDA were pneumonitis, colitis, immune-mediated hepatitis, and death not otherwise specified.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (≥20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (≥20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (≥20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA; those ≥1% were pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression: 2 from complications after allogeneic HSCT and 1 from unknown cause. The most common adverse reactions (≥20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, rash, and cough (20% each).

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those ≥1% were pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression: 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (≥20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (≥20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-A39, when KEYTRUDA was administered in combination with enfortumab vedotin-ejfv to patients with locally advanced or metastatic urothelial cancer (n=440), fatal adverse reactions occurred in 3.9% of patients, including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%). Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with enfortumab vedotin-ejfv; the serious adverse reactions in ≥2% of patients were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Permanent discontinuation of KEYTRUDA occurred in 27% of patients. The most common adverse reactions (≥2%) resulting in permanent discontinuation of KEYTRUDA were pneumonitis/ILD (4.8%) and rash (3.4%). The most common adverse reactions (≥20%) occurring in patients treated with KEYTRUDA in combination with enfortumab vedotin-ejfv were rash (68%), peripheral neuropathy (67%), fatigue (51%), pruritus (41%), diarrhea (38%), alopecia (35%), weight loss (33%), decreased appetite (33%), nausea (26%), constipation (26%), dry eye (24%), dysgeusia (21%), and urinary tract infection (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those ≥2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (≥20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those ≥2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (≥20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-B15, the most common adverse reactions (≥20%) occurring in cisplatin-eligible patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin-ejfv (n=403) were rash (63%), fatigue (48%), pruritus (46%), peripheral neuropathy (43%), diarrhea (36%), alopecia (32%), decreased appetite (29%), nausea and dysgeusia (28% each), constipation (27%), urinary tract infection (UTI) and dry eye (25% each), weight loss (22%), and hyperglycemia (20%).

In the neoadjuvant phase of KEYNOTE-B15, serious adverse reactions occurred in 27% (n=403) of patients; the most frequent (≥1.5%) were rash (3.2%), pneumonitis/interstitial lung disease (ILD) (2.2%), and diarrhea (1.7%). Fatal adverse reactions occurred in 1.7% of patients, including multiple organ dysfunction syndrome (0.5%) and COVID-19 pneumonia, cardiac arrest, pneumonia, septic shock, and urosepsis (0.2% each). Additional fatal adverse reactions were reported in 2 patients in the post-surgery phase before adjuvant treatment started, including pneumonia and sepsis (1 patient each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 17% of patients. The most frequent (>1%) adverse reactions resulting in permanent discontinuation of KEYTRUDA were rash (2.2%), increased alanine aminotransferase (ALT) and pneumonitis/ILD (1.7% each), and hepatitis (1.2%).

Of the 403 patients in the KEYTRUDA in combination with enfortumab vedotin-ejfv arm who received neoadjuvant treatment, 13 patients (3.2%) did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery were multiple organ dysfunction syndrome (0.5%) and adenocarcinoma of colon, COVID-19 pneumonia, cardiac arrest, chronic obstructive pulmonary disease, coronary artery disease, glomerulonephritis, immune-mediated lung disease, myocarditis, pneumonia, pneumonitis, and urosepsis (0.2% each).

Of the 351 patients who received neoadjuvant treatment with KEYTRUDA in combination with enfortumab vedotin-ejfv and underwent radical cystectomy, 26 patients (7%) experienced delay of surgery (defined as time from last neoadjuvant treatment to surgery exceeding 8 weeks) due to adverse reactions.

In the adjuvant phase of KEYNOTE-B15, serious adverse reactions occurred in 35% (n=249) of patients; the most frequent (≥1.5%) were UTI (8%), sepsis (2.8%), and diarrhea, hyperglycemia, and pneumonitis/ILD (1.6% each). Fatal adverse reactions occurred in 3.2% of patients, including death (0.8%) and cardiac arrest, duodenal ulcer perforation, acute pancreatitis, renal failure, small cell lung cancer, and toxic shock syndrome (0.4% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 23% of patients; the most frequent (>1%) were diarrhea and pneumonitis/ILD (2.4% each), rash (2%), and hyperglycemia and sepsis (1.2% each).

In KEYNOTE-905, the most common adverse reactions (≥20%) occurring in cisplatin-ineligible patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin-ejfv (n=167) were rash (54%), pruritus (47%), fatigue (47%), peripheral neuropathy (39%), alopecia (35%), dysgeusia (35%), diarrhea (34%), constipation (28%), decreased appetite (28%), nausea (26%), UTI (24%), dry eye (21%), and weight loss (20%).

In the neoadjuvant phase of KEYNOTE-905, serious adverse reactions occurred in 27% (n=167) of patients; the most frequent (≥2%) were UTI (3.6%) and hematuria (2.4%). Fatal adverse reactions occurred in 1.2% of patients, including myasthenia gravis and toxic epidermal necrolysis (0.6% each). Additional fatal adverse reactions were reported in 2.7% of patients in the post-surgery phase before adjuvant treatment started, including sepsis and intestinal obstruction (1.4% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 15% of patients; the most frequent (>1%) were rash (2.4%, including generalized exfoliative dermatitis) and increased ALT, increased aspartate aminotransferase, diarrhea, dysgeusia, and toxic epidermal necrolysis (1.2% each). Of the 167 patients in the KEYTRUDA in combination with enfortumab vedotin-ejfv arm who received neoadjuvant treatment, 7 patients (4.2%) did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery were acute myocardial infarction, bile duct cancer, colon cancer, respiratory distress, UTI, and two deaths due to myasthenia gravis and toxic epidermal necrolysis (0.6% each).

Of the 146 patients who received neoadjuvant treatment with KEYTRUDA in combination with enfortumab vedotin-ejfv and underwent radical cystectomy, 6 patients (4.1%) experienced delay of surgery (defined as time from last neoadjuvant treatment to surgery exceeding 8 weeks) due to adverse reactions.

In the adjuvant phase of KEYNOTE-905, serious adverse reactions occurred in 45% (n=96) of patients; the most frequent (≥2%) were UTI (8%); acute kidney injury and pyelonephritis (5% each); urosepsis (4.2%); and hypokalemia, intestinal obstruction, and sepsis (2.1% each). Fatal adverse reactions occurred in 7% of patients, including urosepsis, intracranial hemorrhage, death, myocardial infarction, multiple organ dysfunction syndrome, and pseudomonal pneumonia (1% each). Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 29% of patients; the most frequent (>2%) were diarrhea (5%), peripheral neuropathy, acute kidney injury, and pneumonitis (2% each).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those ≥2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (≥20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with MSI-H or dMMR CRC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158 and KEYNOTE-164, adverse reactions occurring in patients with MSI-H or dMMR cancer were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-811, fatal adverse reactions occurred in 3 patients who received KEYTRUDA in combination with trastuzumab and CAPOX (capecitabine plus oxaliplatin) or FP (5-FU plus cisplatin) and included pneumonitis in 2 patients and hepatitis in 1 patient. KEYTRUDA was discontinued due to adverse reactions in 13% of 350 patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma. Adverse reactions resulting in permanent discontinuation of KEYTRUDA in ≥1% of patients were pneumonitis (2.0%) and pneumonia (1.1%). In the KEYTRUDA arm vs placebo, there was a difference of ≥5% incidence between patients treated with KEYTRUDA vs standard of care for diarrhea (53% vs 47%), rash (35% vs 28%), hypothyroidism (11% vs 5%), and pneumonia (11% vs 5%).

In KEYNOTE-859, when KEYTRUDA was administered in combination with fluoropyrimidine- and platinum-containing chemotherapy, serious adverse reactions occurred in 45% of 785 patients. Serious adverse reactions in >2% of patients included pneumonia (4.1%), diarrhea (3.9%), hemorrhage (3.9%), and vomiting (2.4%). Fatal adverse reactions occurred in 8% of patients who received KEYTRUDA, including infection (2.3%) and thromboembolism (1.3%). KEYTRUDA was permanently discontinued due to adverse reactions in 15% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were infections (1.8%) and diarrhea (1.0%). The most common adverse reactions (reported in ≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were peripheral neuropathy (47%), nausea (46%), fatigue (40%), diarrhea (36%), vomiting (34%), decreased appetite (29%), abdominal pain (26%), palmar-plantar erythrodysesthesia syndrome (25%), constipation (22%), and weight loss (20%).

In KEYNOTE-590, when KEYTRUDA was administered with cisplatin and fluorouracil to patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation, KEYTRUDA was discontinued due to adverse reactions in 15% of 370 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were pneumonitis (1.6%), acute kidney injury (1.1%), and pneumonia (1.1%). The most common adverse reactions (≥20%) with KEYTRUDA in combination with chemotherapy were nausea (67%), fatigue (57%), decreased appetite (44%), constipation (40%), diarrhea (36%), vomiting (34%), stomatitis (27%), and weight loss (24%).

Adverse reactions occurring in patients with esophageal cancer who received KEYTRUDA as a monotherapy were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-A18, when KEYTRUDA was administered with CRT (cisplatin plus external beam radiation therapy [EBRT] followed by brachytherapy [BT]) to patients with FIGO 2014 Stage III-IVA cervical cancer, fatal adverse reactions occurred in 1.4% of 294 patients, including 1 case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 34% of patients; those ≥1% included urinary tract infection (3.1%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 9% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). For patients treated with KEYTRUDA in combination with CRT, the most common adverse reactions (≥10%) were nausea (56%), diarrhea (51%), urinary tract infection (35%), vomiting (34%), fatigue (28%), hypothyroidism (23%), constipation (20%), weight loss (19%), decreased appetite (18%), pyrexia (14%), abdominal pain and hyperthyroidism (13% each), dysuria and rash (12% each), back and pelvic pain (11% each), and COVID-19 (10%).

In KEYNOTE-826, when KEYTRUDA was administered in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab (n=307), to patients with persistent, recurrent, or first-line metastatic cervical cancer regardless of tumor PD-L1 expression who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent, fatal adverse reactions occurred in 4.6% of patients, including 3 cases of hemorrhage, 2 cases each of sepsis and due to unknown causes, and 1 case each of acute myocardial infarction, autoimmune encephalitis, cardiac arrest, cerebrovascular accident, femur fracture with perioperative pulmonary embolus, intestinal perforation, and pelvic infection. Serious adverse reactions occurred in 50% of patients receiving KEYTRUDA in combination with chemotherapy with or without bevacizumab; those ≥3% were febrile neutropenia (6.8%), urinary tract infection (5.2%), anemia (4.6%), and acute kidney injury and sepsis (3.3% each).

KEYTRUDA was discontinued in 15% of patients due to adverse reactions. The most common adverse reaction resulting in permanent discontinuation (≥1%) was colitis (1%).

For patients treated with KEYTRUDA, chemotherapy, and bevacizumab (n=196), the most common adverse reactions (≥20%) were peripheral neuropathy (62%), alopecia (58%), anemia (55%), fatigue/asthenia (53%), nausea and neutropenia (41% each), diarrhea (39%), hypertension and thrombocytopenia (35% each), constipation and arthralgia (31% each), vomiting (30%), urinary tract infection (27%), rash (26%), leukopenia (24%), hypothyroidism (22%), and decreased appetite (21%).

For patients treated with KEYTRUDA in combination with chemotherapy with or without bevacizumab, the most common adverse reactions (≥20%) were peripheral neuropathy (58%), alopecia (56%), fatigue (47%), nausea (40%), diarrhea (36%), constipation (28%), arthralgia (27%), vomiting (26%), hypertension and urinary tract infection (24% each), and rash (22%).

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with previously treated recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

In KEYNOTE-394, KEYTRUDA was discontinued due to adverse reactions in 13% of 299 patients with previously treated hepatocellular carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was ascites (2.3%). The most common adverse reactions in patients receiving KEYTRUDA (≥10%) were pyrexia (18%), rash (18%), diarrhea (16%), decreased appetite (15%), pruritus (12%), upper respiratory tract infection (11%), cough (11%), and hypothyroidism (10%).

In KEYNOTE-966, when KEYTRUDA was administered in combination with gemcitabine and cisplatin, KEYTRUDA was discontinued for adverse reactions in 15% of 529 patients with locally advanced unresectable or metastatic biliary tract cancer. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 55% of patients. The most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood cell count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased ALT (2.6%), increased AST (2.5%), and biliary obstruction (2.3%).

In KEYNOTE-017 and KEYNOTE-913, adverse reactions occurring in patients with MCC (n=105) were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (≥20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

In KEYNOTE-564, when KEYTRUDA was administered as a single agent for the adjuvant treatment of renal cell carcinoma, serious adverse reactions occurred in 20% of patients receiving KEYTRUDA; the serious adverse reactions (≥1%) were acute kidney injury, adrenal insufficiency, pneumonia, colitis, and diabetic ketoacidosis (1% each). Fatal adverse reactions occurred in 0.2% including 1 case of pneumonia. Discontinuation of KEYTRUDA due to adverse reactions occurred in 21% of 488 patients; the most common (≥1%) were increased ALT (1.6%), colitis (1%), and adrenal insufficiency (1%). The most common adverse reactions (≥20%) were musculoskeletal pain (41%), fatigue (40%), rash (30%), diarrhea (27%), pruritus (23%), and hypothyroidism (21%).

In KEYNOTE-868, when KEYTRUDA was administered in combination with chemotherapy (paclitaxel and carboplatin) to patients with advanced or recurrent endometrial carcinoma (n=382), serious adverse reactions occurred in 35% of patients receiving KEYTRUDA in combination with chemotherapy, compared to 19% of patients receiving placebo in combination with chemotherapy (n=377). Fatal adverse reactions occurred in 1.6% of patients receiving KEYTRUDA in combination with chemotherapy, including COVID-19 (0.5%) and cardiac arrest (0.3%). KEYTRUDA was discontinued for an adverse reaction in 14% of patients. Adverse reactions occurring in patients treated with KEYTRUDA and chemotherapy were generally similar to those observed with KEYTRUDA alone or chemotherapy alone, with the exception of rash (33% all Grades; 2.9% Grades 3-4).

Adverse reactions occurring in patients with MSI-H or dMMR endometrial carcinoma who received KEYTRUDA as a single agent were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a single agent.

Adverse reactions occurring in patients with recurrent or metastatic cSCC or locally advanced cSCC were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-522, when KEYTRUDA was administered with neoadjuvant chemotherapy (carboplatin and paclitaxel followed by doxorubicin or epirubicin and cyclophosphamide) followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent (n=778) to patients with newly diagnosed, previously untreated, high-risk early-stage TNBC, fatal adverse reactions occurred in 0.9% of patients, including 1 each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving KEYTRUDA; those ≥2% were febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). KEYTRUDA was discontinued in 20% of patients due to adverse reactions. The most common reactions (≥1%) resulting in permanent discontinuation were increased ALT (2.7%), increased AST (1.5%), and rash (1%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA with chemotherapy followed by KEYTRUDA alone were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).

In KEYNOTE-D19, when KEYTRUDA was administered in combination with sacituzumab govitecan-hziy to patients with unresectable locally advanced or metastatic TNBC who had not been previously treated with systemic therapy for advanced disease and whose tumors express PD-L1 (n=221), fatal adverse reactions occurred in 3.2% of patients, including death due to unknown cause (0.9%), completed suicide, neutropenic sepsis, sepsis, pneumonia, and pulmonary embolism (0.5% each).

Serious adverse reactions occurred in 38% of patients receiving KEYTRUDA in combination with sacituzumab govitecan-hziy. Serious adverse reactions in ≥2% of patients were febrile neutropenia (7%), neutropenia (6%), diarrhea (5%), fatigue and pneumonia (2.3% each).

Permanent discontinuation of KEYTRUDA due to an adverse reaction occurred in 9% of patients. The adverse reactions which resulted in permanent discontinuation of KEYTRUDA most commonly (≥1%) were pneumonitis and rash (1.4% each).

Dosage interruptions of KEYTRUDA due to adverse reactions occurred in 67% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included neutropenia (36%), diarrhea (7%), upper respiratory tract infection (4.5%), anemia (4.1%), fatigue (4.1%), increased alanine aminotransferase (ALT) (3.2%), cough, leukopenia, nausea, pyrexia, rash, vomiting (2.7% each), and COVID-19 (2.3%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, occurring in patients treated with KEYTRUDA in combination with sacituzumab govitecan-hziy were decreased neutrophil count and decreased hemoglobin (86% each), decreased leukocyte count (84%), diarrhea (72%), nausea (68%), decreased lymphocyte count (61%), fatigue (58%), alopecia (52%), increased alkaline phosphatase and increased glucose (50% each), increased ALT (47%), constipation (41%), increased aspartate aminotransferase (40%), rash (37%), decreased potassium (35%), increased lactate dehydrogenase (34%), vomiting (29%), abdominal pain, headache, increased eosinophils (26% each), and decreased albumin (25%).

In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). KEYTRUDA was discontinued in 11% of patients due to adverse reactions. The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%).

In KEYNOTE-B96, when KEYTRUDA was administered in combination with paclitaxel, with or without bevacizumab, serious adverse reactions occurred in 54% of patients. Serious adverse reactions in ≥2% of patients were pneumonia (4.3%), urinary tract infection (3.9%), adrenal insufficiency (3%), hyponatremia (3%), COVID-19, decreased neutrophil count, pulmonary embolism (2.6% each), abdominal pain, anemia, colitis, diarrhea, febrile neutropenia, pyrexia, and vomiting (2.1% each).

Fatal adverse reactions occurred in 3.9% of patients receiving KEYTRUDA and paclitaxel, with or without bevacizumab, including assisted suicide (0.9%), death, intestinal perforation, sepsis, COVID-19, cardio-respiratory arrest, colitis, and embolic stroke (0.4% each).

KEYTRUDA was permanently discontinued for adverse reactions in 16% of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA (≥1%) were colitis and increased alanine aminotransferase (1.3% each). Adverse reactions leading to the interruption of KEYTRUDA occurred in 44% of patients. The most common adverse reactions leading to interruption of KEYTRUDA in ≥2% were urinary tract infection (3.9%), adrenal insufficiency, pyrexia, pneumonitis, upper respiratory tract infection (2.6% each), neutropenia, diarrhea, and COVID-19 (2.1% each).

The most common adverse reactions (≥20%) for patients treated with KEYTRUDA in combination with paclitaxel, with or without bevacizumab, were diarrhea (45%), fatigue (43%), nausea (41%), alopecia, peripheral neuropathy (38% each), epistaxis (31%), urinary tract infection (27%), constipation (25%), abdominal pain, decreased appetite, vomiting (24% each), hypothyroidism (21%), cough, hypertension, and rash (20% each).

For patients treated with KEYTRUDA in combination with paclitaxel and bevacizumab (N=169), decreased white blood cell count (27%), stomatitis (22%), and pyrexia (21%) were also reported as adverse reactions.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose.

Pediatric Use

In KEYNOTE-051, 173 pediatric patients (65 pediatric patients aged 6 months to younger than 12 years and 108 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. The median duration of exposure was 2.1 months (range: 1 day to 25 months).

Adverse reactions that occurred at a ≥10% higher rate in pediatric patients when compared to adults were pyrexia (33%), leukopenia (30%), vomiting (29%), neutropenia (28%), headache (25%), abdominal pain (23%), thrombocytopenia (22%), Grade 3 anemia (17%), decreased lymphocyte count (13%), and decreased white blood cell count (11%).

Geriatric Use

Of the 564 patients with locally advanced or metastatic urothelial cancer treated with KEYTRUDA in combination with enfortumab vedotin-ejfv, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. No overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin-ejfv experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older.

Of the 570 patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin-ejfv, 45% (n=259) were 65-74 years and 22% (n=125) were 75 years or older. No overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. Patients 75 years of age or older treated with KEYTRUDA in combination with enfortumab vedotin-ejfv experienced a higher incidence of fatal adverse reactions than younger patients. The incidence of fatal adverse reactions was 3.6% in patients younger than 75 and 11% in patients 75 years or older.

Of 221 adult patients with TNBC who were treated with KEYTRUDA in combination with sacituzumab govitecan-hziy in KEYNOTE-D19, 26% of patients were 65 years and over and 5% were 75 years and older. No overall differences in effectiveness were observed between elderly patients and younger patients. There was a higher rate of serious adverse reactions in patients aged 65 years or older (48%) compared with younger adult patients (34%).

Additional Selected Indications in the U.S. for KEYTRUDA

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is:

Stage III where patients are not candidates for surgical resection or definitive chemoradiation, ormetastatic.KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-authorized test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Malignant Pleural Mesothelioma

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

Head and Neck Squamous Cell Cancer

KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-authorized test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Cancer

KEYTRUDA, in combination with enfortumab vedotin-ejfv, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:

who are not eligible for any platinum-containing chemotherapy, orwho have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.KEYTRUDA, in combination with enfortumab vedotin-ejfv, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).

KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test.

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA-authorized test.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, oras a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.Cervical Cancer

KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen.

Biliary Tract Cancer

KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Endometrial Carcinoma

KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.

KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-authorized test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with sacituzumab govitecan-hziy, is indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

Ovarian Cancer

KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

Merck’s focus on cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 20 novel mechanisms. With one of the largest clinical development programs across more than 25 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna’s mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company’s values and mindsets, Moderna’s mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

Moderna's focus on cancer

At Moderna, we are delivering on the promise of mRNA science to create a new generation of transformative medicines for patients. We are relentlessly working to grow our cancer therapeutic modality by discovering mRNA medicines that harness the body's immune system to identify and kill cancer cells in the same way the immune system identifies and targets infections. One example of a promising oncology candidate is the creation of individualized, mRNA-based cancer therapies. We also continue to strengthen our portfolio through strategic collaborations that increase our potential to improve treatment options for patients with cancer.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: engagement with regulatory authorities; the favorable trend in overall survival data; further evaluation of overall survival and other key endpoints; the potential for treating patients with earlier-stage melanoma in the adjuvant setting; the potential of intismeran in other tumor types and across settings; the curative potential of intismeran in combination with KEYTRUDA; the potential of mRNA for the treatment of cancer and other serious diseases; efficacy and safety; and the advancement of the INTerpath clinical development plan, including nine current Phase 2 and Phase 3 clinical trials. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Please see Prescribing Information for KEYTRUDA at https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Patient Information/Medication Guide for KEYTRUDA at https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261022568161/en/

Since 2020, around 1 million prospective new car buyers have left the market and aren't expected to return any time soon, according to The Wall Street Journal.

Before 2020, Americans were buying roughly 17 million cars and trucks per year, but that number is expected to be 16 million or fewer this year; analysts don't foresee those totals reaching 17 million again until the end of the decade or later. Stubborn inflation, high interest rates, and fuel costs have joined forces to keep more buyers on the sidelines, a concern for automakers.

That said, that dynamic can also be a boon for certain companies as more people hold on to their vehicles longer and pay for repairs rather than opting for a new vehicle. One company in particular that can benefit from that dynamic is Genuine Parts (GPC +2.52%).

Image source: Getty Images.

The beneficiary of sluggish new car sales
Genuine Parts is a global provider of automotive accessories, replacement parts, and solutions. The name may not sound familiar to some, but what's more familiar is its NAPA Auto Parts brand, which includes just under 6,000 company-owned and independently owned NAPA stores in the United States.

Those stores offer everything from batteries to brakes to motor oil. Through its auto care centers, NAPA also provides brake services, oil changes, transmission repairs, and more. Essentially, it genuinely helps keep cars and trucks on the roads longer as new car purchases are being delayed.

GPC Genuine Parts$127.93+$3.15 (+2.52%)

NYSE · As of 3:56 PM ET 10/22/26

Earnings results and a spinoff
On Oct. 20, Genuine reported its 2026 third-quarter earnings results, which the market did not care for. Revenue was $6.5 billion, a 4.2% increase from the prior-year period, while net income was $224 million, a decline of 0.9%. The stock price dropped 6.6% on the day, but there's a reason this may have created an opportunity for more aggressive investors.

In addition to its automotive division, Genuine has an industrial division that provides replacement parts and original equipment components under the Motion brand. To focus each segment of the company on what it does best, however, Genuine will separate its automotive and industrial divisions; the spinoff is expected to be finalized in the first quarter of 2027.

Focusing solely on the automotive sector can enable the automotive group to maintain a stronger focus, make faster decisions, and redeploy earnings directly back into its business.

The long-term plan
A $2,500 investment today could turn into meaningfully more, but there's no near-term forecast to offer, as current one-year price targets are still based on the company as a whole. This would be an investment for those considering holding the shares for years, as it will take time for the automotive division to show what it can do on its own, and markets will need some time to digest how to value the company after its split.

That said, as Genuine can benefit from fewer new cars being sold and from a renewed strategic focus through the upcoming spinoff, the catalysts are in place to make an investment today more valuable in the years ahead. As a bonus, the spinoff could also benefit the industrial division, and shareholders will receive a stake in it when the auto and industrial segments separate.

Complaint alleges Hyliion Holdings Corp. misled investors between May 12, 2026 and June 23, 2026; investors may seek lead plaintiff role by October 27, 2026

, /PRNewswire/ -- Glancy Prongay Wolke & Rotter LLP ("Glancy") announced today that the class action lawsuit covers investors who bought Hyliion Holdings Corp. ("Hyliion" or the "Company") (NYSE: HYLN) securities between May 12, 2026 and June 23, 2026. The Hyliion Holdings Corp. case, Olmeta v. Hyliion Holdings Corp., et al., was filed on August 28, 2026 in the U.S. District Court for the Western District of Texas (Case No. 1:26-cv-02375).

Investors who suffered losses on Hyliion Holdings Corp. investments can submit their Hyliion Holdings Corp. loss information here before the October 27, 2026 lead plaintiff deadline.

Key dates in the Hyliion Holdings Corp. case

Class period: May 12, 2026 to June 23, 2026
Complaint filed: August 28, 2026
Lead plaintiff deadline: October 27, 2026

What happened?

On June 23, 2026, Pelican Way Research issued a report entitled "Hyliion: A Glorified Science Project Who Has Continuously Failed to Meet Expectations And Is Now Throwing Around A Meaningless Deal." The report alleged that a recent letter of intent the Company announced with VFG Holdings, LLC ("VFG") for a major deal "is a sham" because VFG "does not appear to have any substance," has a website that "contains just two pages" and appears to only have four employees. The report called into question whether VFG is an "AI data center integrator" capable of the deal previously announced by the Company.

On this news, the price of Hyliion stock fell $1.27 per share, or 17.2%, to close at $6.10 on June 23, 2026, thereby injuring investors. The following day, Hyliion stock fell another $1.18 per share, or 19.3%, to close at $4.92 on June 24, 2026, thereby injuring investors further.

What is the Hyliion Holdings Corp. lawsuit about?

The Hyliion Holdings Corp. securities lawsuit alleges that, between May 12, 2026 and June 23, 2026, defendants made materially false and/or misleading statements and failed to disclose material adverse facts about Hyliion Holdings Corp.'s business, operations, and prospects. Specifically, the complaint alleges defendants failed to disclose that: (1) in order to cause rapid price appreciation in Hyliion stock, Defendants announced a deal with an entity that was very recently formed and does not appear to have any actual business operations; (2) the Individual Defendants timed the announcement and foregoing price appreciation to insider trade; and (3) as a result, defendants' positive statements about Hyliion Holdings Corp.'s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

"The complaint filed against Hyliion Holdings Corp. alleges that, among other things, the Company failed to disclose that in order to cause rapid price appreciation in Hyliion stock, Defendants announced a deal with an entity that was very recently formed and does not appear to have any actual business operations. For investors who bought during the class period, the October 27, 2026 deadline is the first major step in this case," said Charles H. Linehan, Partner at Glancy Prongay Wolke & Rotter LLP.

What's the next step?

Glancy Prongay Wolke & Rotter LLP is a leading national shareholder rights law firm, ready to assist Hyliion Holdings Corp. investors in potentially pursuing claims to recover their losses.

If you wish to serve as lead plaintiff in the Hyliion Holdings Corp. class action, you must move the Court no later than October 27, 2026. To learn more about your rights, visit the Hyliion Holdings Corp. case page, email [email protected], or call 310-201-9150 (toll-free: 888-773-9224).

You may retain counsel of your choice. If you bought Hyliion Holdings Corp. securities during the class period, you may take no action and remain an absent class member. No class has been certified yet in the Hyliion Holdings Corp. case.

Frequently Asked Questions

Who is eligible? Investors who purchased or otherwise acquired Hyliion Holdings Corp. securities between May 12, 2026 and June 23, 2026 and suffered losses may be members of the proposed class in the Hyliion Holdings Corp. shareholder lawsuit. Any class member may ask the court to appoint them lead plaintiff by October 27, 2026.

What is a lead plaintiff? In the Hyliion Holdings Corp. class action, the lead plaintiff is the investor, or group of investors, that the court appoints to represent all class members and oversee the case. Under the Private Securities Litigation Reform Act, courts generally presume the movant with the largest financial interest is the most adequate lead plaintiff.

Do I have to be lead plaintiff to recover? No. A Hyliion Holdings Corp. investor's ability to share in any future recovery does not depend on serving as lead plaintiff. Hyliion Holdings Corp. investors may take no action and remain absent class members.

What is the deadline? Motions to serve as lead plaintiff in the Hyliion Holdings Corp. class action must be filed by October 27, 2026.

Does it cost anything to contact Glancy or participate in this action? Glancy represents Hyliion Holdings Corp. investors on a contingency fee basis, which means investors pay no attorneys' fees unless there is a recovery. Any fees are subject to court approval and are paid from the recovery.

Can I choose my own lawyer? Yes. Hyliion Holdings Corp. investors may retain counsel of their choice.

Why work with Glancy on the Hyliion Holdings Corp. lawsuit? Glancy Prongay Wolke & Rotter LLP is a premier law firm with decades of experience representing investors and consumers in securities litigation and other complex class action litigation. Contact Glancy about the Hyliion Holdings Corp. lawsuit. Prior results do not guarantee a similar outcome.

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Palantir (PLTR -2.84%) has a major event coming in a few weeks: third-quarter earnings. Investors are always looking forward to these reports from Palantir because it's one of the few companies that reports on a Monday, so all eyes will be on it. Additionally, Palantir has a tremendous track record of beating expectations, and investors will be expecting another beat this quarter.

However, if it doesn't announce a beat, I would expect the stock to tumble, as that is what's currently priced in. Palantir has had an incredible run, but I think it must project continued revenue growth acceleration to maintain its run.

Image source: The Motley Fool.

Palantir's growth has been impressive
Palantir's AI-powered data analytics software has become more popular over the past two decades. It started as a government-focused company, providing software to various government entities. This eventually expanded into the commercial sector, where it's seeing the fastest growth today. Still, government revenue accounts for more than half of Palantir's total revenue.

Palantir's strength lies in its ability to work within existing systems and deliver actionable insights quickly. This can work in a fully automated environment or with human intervention as the final approval before an action is performed. Palantir has become a popular way for businesses across industries to integrate AI into their existing systems, and this shows up in its financials.

PLTR Palantir Technologies$196.00-$5.72 (-2.84%)

NASDAQ · As of 3:51 PM ET 10/22/26

During the second quarter, its U.S. commercial revenue grew at a breathtaking 149% pace, while U.S. government revenue increased 90%. Overall, Palantir's revenue rose 93% year over year to $1.94 billion. That overall figure is important to note because Palantir only guided for about $1.8 billion in Q2 revenue. That's a significant beat, but Palantir has been underguiding and overdelivering for some time.

For Q3, management expects revenue of $2.16 billion. That projects an 83% revenue growth rate, which would be a deceleration from Q2's level. However, if Palantir beats revenue expectations by a similar amount to Q2 (about $150 million), that would boost Palantir's growth rate to 96%, allowing it to continue reporting accelerating revenue growth.

It's important that Palantir does this because its valuation suggests that it needs to continue doubling each year.

Palantir is very expensive
There is a ton of future growth priced into Palantir stock, and if the company starts reporting slowing growth, then the stock could sell off as a result. Palantir currently trades at 120 times forward earnings.

PLTR PE Ratio (Forward) data by YCharts

Most big tech stocks average about a 30x trailing earnings valuation, so for Palantir to reach that level, it would need to quadruple its earnings. Most rapidly growing tech companies don't have their profitability optimized, so earnings can grow through a combination of revenue growth and margin expansion. However, in Q2, Palantir's profit margin reached 55%. That's about as good as it gets, so for Palantir to expand its earnings total, it must grow its revenue base.

If Palantir's earnings and revenue grow at a 1-to-1 ratio, then Palantir's earnings must quadruple after accounting for 2026's results. That's huge growth, and if Palantir starts to report slowing revenue growth, that figure will be hard to achieve. So, all eyes will be on Palantir on Nov. 2, because if its revenue growth starts to slip, the stock may have a rough day on Nov. 3. However, if it reports accelerating revenue growth, I wouldn't be surprised to see Palantir's run continue, although a significant rise may be off the table due to how much growth is already priced into the stock.

, /PRNewswire/ -- The Board of Directors of Air Products (NYSE:APD) today declared a quarterly dividend of $1.81 per share of common stock.

The dividend is payable on February 8, 2027 to shareholders of record at the close of business on January 4, 2027.

About Air Products 

Air Products (NYSE: APD) is a world-leading industrial gases company in operation for over 85 years focused on serving energy, environmental, and emerging markets and generating a cleaner future. The Company supplies essential industrial gases, related equipment and applications expertise to customers in dozens of industries, including refining, chemicals, metals, electronics, manufacturing, medical and food. As the leading global hydrogen supplier, Air Products develops, engineers, builds, owns and operates some of the world's largest hydrogen projects. Through its sale of equipment businesses, the Company also provides turbomachinery, membrane systems and cryogenic containers globally.

Air Products had fiscal 2025 sales of $12.0 billion from operations in approximately 50 countries. For more information, visit airproducts.com or follow us on LinkedIn, X, Facebook or Instagram.

SOURCE Air Products

Dell added governed AI software, deskside templates and modular infrastructure as its AI Factory customer base reached 6,500.

Summary

Dell’s customer count is rising, but the stock now demands cleaner backlog conversion.

Enterprise-computing supplier Dell Technologies DELL expanded its Nvidia-backed AI Factory offerings, but shares fell approximately 7.04% to $451.70 as of 11:20 a.m. ET Thursday. The rollout spans desktop AI systems, servers and modular data centers. More products mean more opportunities to win business. They also raise the bar for execution.

Dell says AI Factory adoption topped 6,500 customers, versus 5,000 last quarter—roughly 30% growth. Its fiscal-second-quarter results also showed $60.9 billion in AI-server orders, $16.4 billion in AI-server revenue and a $95 billion ending backlog. Demand looks substantial. The next test is turning those commitments into shipments, profits and cash.

The valuation snapshot puts Dell 87.19% above its $241.31 GF Value estimate, suggesting hefty growth expectations remain baked into the price despite the decline. That estimate is a valuation reference, not a guaranteed destination. Investors should watch AI-server margins, cash generation and backlog conversion: a huge order book matters most when fulfilling it produces attractive returns.

Disclosures
I/we have no positions in any stocks mentioned, and have no plans to buy any new positions in the stocks mentioned within the next 72 hours.

Click for the complete disclosure

Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? Flowserve (FLS - Free Report) , which belongs to the Zacks Manufacturing - General Industrial industry, could be a great candidate to consider.

When looking at the last two reports, this company that makes pumps, valves and other parts for the oil and gas industries has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 7.06%, on average, in the last two quarters.

For the last reported quarter, Flowserve came out with earnings of $0.95 per share versus the Zacks Consensus Estimate of $0.86 per share, representing a surprise of 10.47%. For the previous quarter, the company was expected to post earnings of $0.82 per share and it actually produced earnings of $0.85 per share, delivering a surprise of 3.66%.

Price and EPS Surprise

With this earnings history in mind, recent estimates have been moving higher for Flowserve. In fact, the Zacks Earnings ESP (Expected Surprise Prediction) for the company is positive, which is a great sign of an earnings beat, especially when you combine this metric with its nice Zacks Rank.

Our research shows that stocks with the combination of a positive Earnings ESP and a Zacks Rank #3 (Hold) or better produce a positive surprise nearly 70% of the time. In other words, if you have 10 stocks with this combination, the number of stocks that beat the consensus estimate could be as high as seven.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a version of the Zacks Consensus whose definition is related to change. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

Flowserve currently has an Earnings ESP of +0.34%, which suggests that analysts have recently become bullish on the company's earnings prospects. This positive Earnings ESP when combined with the stock's Zacks Rank #3 (Hold) indicates that another beat is possibly around the corner. We expect the company's next earnings report to be released on October 28, 2026.

Investors should note, however, that a negative Earnings ESP reading is not indicative of an earnings miss, but a negative value does reduce the predictive power of this metric.

Many companies end up beating the consensus EPS estimate, but that may not be the sole basis for their stocks moving higher. On the other hand, some stocks may hold their ground even if they end up missing the consensus estimate.

Because of this, it's really important to check a company's Earnings ESP ahead of its quarterly release to increase the odds of success. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Super Micro Computer, Inc. (NASDAQ:SMCI) stock traded lower Thursday as investors weighed renewed supply-chain concerns across AI hardware, profit-taking after the prior session’s rally and lingering scrutiny around the company’s supply chain.

The decline came during a broader risk-off session, with the S&P 500 down 1.3% and the Technology sector falling 3.1%, making it the weakest of the 11 sectors.

ˆ Super Micro Computer shares are sliding. Why is SMCI stock dropping?

Supply Bottlenecks Pressure AI Hardware SentimentAI infrastructure peer Lam Research Corp. (NASDAQ:LRCX) highlighted near-term supply-chain constraints that could push some December-quarter shipments into March.

Lam still posted a record 40.2% operating margin and guided December-quarter revenue to $8.2 billion-$9 billion, compared with the $8.53 billion estimate. Its warning that shipment timing could shift revenue into a later quarter added pressure to sentiment around hardware suppliers tied to data center expansion.

Super Micro Pulls Back After Revenue-Guide RallySuper Micro shares fell more than 6% as investors took profits following a gain of more than 10% in the previous session.

The earlier rally followed Super Micro’s decision to raise its preliminary fiscal first-quarter 2027 revenue outlook to $18.5 billion-$19.5 billion.

The stock also continued to face concerns tied to a federal export-control investigation involving its supply chain.

Super Micro Expands Nvidia PartnershipSuper Micro also expanded its partnership with NVIDIA Corp. (NASDAQ:NVDA) by introducing a new Vera CPU rack designed to support more AI workloads while using less data center space and power.

The company said customers can deploy the system on its own or alongside Nvidia’s Vera Rubin platform, giving them another option to expand AI infrastructure while potentially reducing deployment and operating costs.

Analysts Remain MixedSuper Micro carries a Buy consensus rating with an average price target of $38, with forecasts ranging from $31 to $57 across 26 analysts.

Rosenblatt maintained a Buy rating and raised its forecast to $57 on Oct. 21, after maintaining a $51 target on Oct. 16. Citigroup maintained Neutral and raised its forecast to $45 on Oct. 8.

Top ETF ExposureThe YieldMax SMCI Option Income Strategy ETF (NYSE:SMCY) carries a 37.67% weighting in SMCI, while the ERShares Entrepreneurs ETF (NASDAQ:ENTR) holds 3.74% and the Inspire Capital Appreciation ETF (NYSE:RISN) holds 3.84%.

Because Super Micro carries meaningful weight in these funds, significant ETF inflows or outflows can translate into corresponding buying or selling of the stock.

SMCI Price ActionSuper Micro Computer shares were down 5.62% at $33.57 at the time of publication on Thursday, according to Benzinga Pro data.

Photo: Shutterstock

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IonQ (IONQ -4.38%) is a leader among the pure-play quantum computing cohort -- and for good reason. It looks much more like a real business than some of its peers, and if it can successfully deliver on its promise, its upside could be significant.

But an exciting young technology doesn't automatically make for a good investment, especially when so much of its promise remains unproven.

So, what might a $1,000 investment in IonQ stock made today be worth five years from now? Let's take a look.

Image source: Getty Images.

Quantum computing's promise faces serious engineering challenges The smartphone or laptop you're reading this on stores and processes information using bits -- 0s and 1s. Quantum computers process data with "qubits" -- quantum bits that are governed by deeper and more counter-intuitive physical laws than we deal with in our everyday lives.

Qubits can temporarily exist in "superposition," holding states that are neither 1 nor 0, but complex probability amplitudes. I won't try to explain that further -- but suffice it to say that this means that quantum computers perform calculations in a fundamentally different way from traditional ones. That difference will allow them to solve problems that are either extremely difficult or impossible for a classical supercomputer to handle in any useful amount of time. 

The expectation is that this could lead to breakthroughs in materials science, drug development, and logistics, among many other fields.

In short, the ability of qubits to behave in ways that ordinary bits don't could be a very big deal.

But this technology is mostly still unproven, at least on any scale that matters. Qubits are hard to get a handle on, and they are extremely sensitive to any outside interference, which makes quantum computers prone to errors. Every player in the space is highly focused on the problems of error mitigation and error prevention. 

There's also a question of scale: Building a system with enough qubits operating together to be useful, and also getting them to perform reliably, is a serious engineering challenge. 

Of course, the potential payoff is huge -- much bigger than just "a faster computer" -- which is a common misconception. Real, practical quantum computing could help us solve currently unsolvable problems and would represent a massive leap forward in human technology.

$30.87-$1.42 (-4.38%)

NYSE · As of 2:56 PM ET 10/22/26

How IonQ's trapped-ion quantum computers work There are numerous ways to make a qubit, and it's far from clear at this point which versions of the technology will deliver most effectively.

IonQ builds its systems around trapped-ion qubits. It uses electromagnetic fields to "trap" individual electrically charged atoms (ions) in place in a vacuum, and then uses lasers to cool and manipulate them. This approach has the major advantage of making the qubits highly stable -- at least relatively. The downside is that it is generally harder to scale than some other approaches.

IonQ's revenue is growing, but losses remain steep Though the technology is still a long way from maturity or real commercial viability, IonQ already has a business. Sales reached $80.1 million in the second quarter, up 287% from a year earlier.

The company sells its early quantum computers and rents access to them via the cloud, but they have real limitations and are largely only useful for research at this point. After a string of acquisitions, the company now also sells quantum networking, security, and sensing equipment, along with space-grade hardware.

Its largest acquisition just closed in July: chip manufacturer SkyWater Technology. That deal helped boost its full-year revenue forecast by about $170 million to between $450 million and $460 million.

Of course, the top line is only half the picture. IonQ's operating loss reached $337 million in Q2, far exceeding its sales. It does have a strong balance sheet, however, with about $2 billion in cash and investments left over after the SkyWater acquisition.

What could IonQ stock be worth in 2031? So what could IonQ look like five years from now?

A bullish scenario IonQ makes real progress, and its systems are starting to be used in real-world work. Demand grows across its product lines. Sales grow at 50% annually, reaching $3.5 billion in 2031. The company is closer to profitability but continues to operate in the red as it scales. A bearish scenario Its quantum computers are still mostly relegated to research and experimentation. Sales of its other product lines grow, but at a much slower pace. Revenues grow at 15% annually, reaching $915 million in 2031. The company is still operating deep in the red, and management uses dilutive stock sales to cover the funding gap. I suspect that practical quantum computing is still much further off than the bullish scenario assumes, and I see IonQ looking more like the latter case five years from now. And in this scenario, I think investors won't be willing to pay the same sort of multiple they are now. 

And that multiple is already an issue. Even after a stock price decline of more than 50% from the 52-week peak it hit early this summer, IonQ is trading at a lofty price-to-sales (P/S) ratio of more than 45.

Assuming a more bearish case prevails, I'd expect that to contract to maybe 10 times sales.

In that case, accounting for further dilution from likely stock sales, I think IonQ shares will be worth about $15 five years from now, which means a $1,000 investment made today would be worth just $487.

Of course, I could be very wrong. Quantum computing tech could progress much faster than I believe. But people have been claiming that useful quantum computers would be here in just a few years for the past decade or two. 

Cadence just posted five straight earnings beats and a record backlog while its stock sits 5% below where it was a year ago. Something has to give before Monday's report, and the answer depends on a margin squeeze and an…

Cadence Design Systems (NASDAQ:CDNS | CDNS Price Prediction) is expected to report third-quarter results Monday, October 26, after the close. The stock is up only 0.61% year to date, so this report needs to justify a premium multiple.

Record Backlog Meets a Stalled Stock Last quarter, revenue rose 24.2% to $1.584B, and non-GAAP EPS of $2.11 beat the $2.06 estimate. Non-GAAP operating margin expanded to 45.5% from 42.8%, and backlog reached a record $8.10B. Management raised full-year revenue guidance to $6.26B to $6.34B.

Growth was broad. Core EDA grew 18%, Semiconductor IP 40%, and System Design and Analysis 37% with help from the Hexagon D&E deal.

Shares have fell behind anyway. At $314.48, the stock is down 5.69% over the past year and well below its $416.69 52-week high. It still trades at 64 times trailing earnings and 32 times forward earnings.

Consensus Calls for 20% Revenue Growth Metric Estimate Prior Year YoY Growth Q3 2026 Normalized EPS $2.046 $1.93 6.0% Q3 2026 Revenue $1.61B $1.339B 20.4% FY 2026 Normalized EPS (guidance midpoint) $8.10 $7.14 13.4% FY 2026 Revenue $6.32B $5.297B 19.3% Margins and Agentic AI Revenue Will Set the Tone Management guided third-quarter non-GAAP operating margin to 43.5% to 44.5%, citing investments in Intel (NASDAQ:INTC) opportunities and the Hexagon integration. CFO John Wall highlighted $20 to 25 million in second-half spending and called it “not a deterioration in the underlying model.” Last year’s quarter ran at a 47.6% margin, which explains the modest EPS growth in consensus. I’ll be watching where margin lands within that range.

Agentic AI is the bigger long-term question. ChipStack has more than 20 customer engagements and ViraStack more than 25, yet Wall said, “We’re still not assuming a sudden step function in our guidance.” You should look for agent licenses or greater engine usage lifting recurring revenue, which grew about 24% in the second quarter.

I also want updates on the Intel 14A agreement, which CEO Anirudh Devgan called 100% additional. Hardware remains supply-constrained, and guidance assumes export controls stay “substantially similar.”

Five Straight Beats Haven’t Fixed the Multiple Cadence has exceeded EPS estimates for five consecutive quarters, yet the stock’s average one-day change after those reports was -0.69%. Options suggest a move of about 6.2%. Analysts remain constructive, with 18 Buy and five Strong Buy ratings and a $406.24 average target. Another beat is already expected. A third guidance raise, plus a credible path to margin recovery in 2027, is what could reset sentiment around the valuation.

Contact [email protected] for any questions or corrections.

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering MarketAxess (MKTX - Free Report) , which belongs to the Zacks Financial - Investment Bank industry.

This operator of bond trading platforms has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average surprise for the past two quarters of 4.19%.

For the last reported quarter, MarketAxess came out with earnings of $1.95 per share versus the Zacks Consensus Estimate of $1.88 per share, representing a surprise of 3.72%. For the previous quarter, the company was expected to post earnings of $2.15 per share and it actually produced earnings of $2.25 per share, delivering a surprise of 4.65%.

Price and EPS Surprise

Thanks in part to this history, there has been a favorable change in earnings estimates for MarketAxess lately. In fact, the Zacks Earnings ESP (Expected Surprise Prediction) for the stock is positive, which is a great indicator of an earnings beat, particularly when combined with its solid Zacks Rank.

Our research shows that stocks with the combination of a positive Earnings ESP and a Zacks Rank #3 (Hold) or better produce a positive surprise nearly 70% of the time. In other words, if you have 10 stocks with this combination, the number of stocks that beat the consensus estimate could be as high as seven.

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a version of the Zacks Consensus whose definition is related to change. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

MarketAxess currently has an Earnings ESP of +8.08%, which suggests that analysts have recently become bullish on the company's earnings prospects. This positive Earnings ESP when combined with the stock's Zacks Rank #3 (Hold) indicates that another beat is possibly around the corner.

Investors should note, however, that a negative Earnings ESP reading is not indicative of an earnings miss, but a negative value does reduce the predictive power of this metric.

Many companies end up beating the consensus EPS estimate, but that may not be the sole basis for their stocks moving higher. On the other hand, some stocks may hold their ground even if they end up missing the consensus estimate.

Because of this, it's really important to check a company's Earnings ESP ahead of its quarterly release to increase the odds of success. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

7 Best Stocks for the Next 30 Days

Just released: Experts distill 7 elite stocks from the current list of 220 Zacks Rank #1 Strong Buys. They deem these tickers "Most Likely for Early Price Pops."

Since 1988, the full list has beaten the market more than 2X over with an average gain of +23.9% per year. So be sure to give these hand picked 7 your immediate attention. 

See them now >>