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Geneva, Switzerland, October 22, 2026 — TRON reinforced its position as a leading blockchain network for stablecoin settlement in the third quarter of 2026, with trillions in transaction volume, record USDT supply, growing payment card adoption, and the debut of the first U.S. spot staked TRX exchange-traded fund (ETF), according to independent research reports from CoinDesk Data and Nansen.

CoinDesk 

CoinDesk’s TRON Network Quarterly Report: Q3 2026 provides a technical assessment of the TRON network from July to September 2026. The findings span network and ecosystem developments, core on-chain metrics, and DeFi activity across lending and decentralized exchanges (DEX).

Key Insights from CoinDesk:

Stablecoin Settlement: TRON accounted for approximately 73% of stablecoin transfer volume at the end of Q3 2026, the highest share among blockchain networks. Stablecoin Market Share & USDT Growth: USDT on TRON reached an all-time high of just over $92.7 billion in Q3 2026, lifting TRON’s share of the total USDT market to a 2026 high of 50.6% in mid-September. TRON’s share of total stablecoin market capitalization also rose to 30.2%.  Crypto-Card Payments & DeFi Activity: TRON ranked first among chains by crypto-card payment volume in Q3 2026, capturing a 27.5% share worth approximately $638 million as total card volumes grew 60.5% QoQ to $2.32 billion. Total value locked (TVL) on the network rose 26.6% QoQ to $5.7 billion with lending the largest sector at 68%, and JustLend active loans up from $127M to $199M. Read the full report from CoinDesk here.

Nansen

Nansen’s TRON Quarterly Report: Q3 2026 examines the network’s settlement scale and on-chain behavior over the quarter. It covers stablecoin settlement volume, transaction and address activity, institutional developments, and how users and transactions are distributed across labeled entities on TRON.

Key Insights from Nansen:

Stablecoin Settlement at Scale: TRON settled $2.21 trillion in stablecoins in Q3 2026, with average daily settlement rising 3.9% to $24.05 billion. Cumulative transaction volume on the network also surpassed $30 trillion as of September 23. User Growth & On-Chain Activity: TRON’s user base continued to grow in Q3 2026, with average rolling monthly active addresses up 9.8% QoQ to 18 million, while the network processed an average of 11.68 million successful transactions per day. Expanded Institutional Access: Canary Capital launched the Canary Staked TRX ETF (TRXS), the first U.S. spot staked TRX ETF, on September 9, and TRON DAO rang the Cboe closing bell on September 29 to mark its debut. Anchorage Digital also added native TRX staking and TRC-20 custody as the second phase of its TRON integration. Read the full report from Nansen here. 

Across both reports, TRON’s third quarter showed a network growing in volume and in reach at the same time. Stablecoin settlement continued to climb, everyday spending through crypto cards accelerated, and new regulated products gave institutions a direct path to TRX. With that foundation in place, TRON enters the final quarter of 2026 as a settlement network that is increasingly accessible to retail users and institutions alike.

About TRON DAO

TRON DAO is a community-governed DAO dedicated to accelerating the decentralization of the internet via blockchain technology and dApps.

Founded in September 2017, the TRON blockchain has experienced significant growth since its MainNet launch in May 2018. Today, TRON hosts the largest circulating supply of USD Tether (USDT) stablecoin, which currently exceeds $94 billion. As of October 2026, the TRON blockchain has recorded over 410 million in total user accounts, more than 15 billion in total transactions, and over $28 billion in total value locked (TVL), based on TRONSCAN. Recognized as the global settlement layer for stablecoin transactions and everyday purchases with proven success, TRON is “Moving Trillions, Empowering Billions.”

TRONNetwork | TRONDAO | X | YouTube | Telegram | Discord | Reddit | GitHub | Medium | Forum

Media Contact

Yeweon Park

[email protected] 

Disclaimer: The information found on NewsBTC is for educational purposes only. It does not represent the opinions of NewsBTC on whether to buy, sell or hold any investments and naturally investing carries risks. You are advised to conduct your own research before making any investment decisions. Use information provided on this website entirely at your own risk.

U.S. Bank completed a live cross-border transfer of its USBDC dollar-backed stablecoin on the Stellar network ($XLM) between its North American and European entities.

U.S. Bank has completed a live cross-border payment using USBDC, its proprietary dollar-backed stablecoin, on the public Stellar blockchain ($XLM). According to the bank's filing with the U.S. Securities and Exchange Commission, the pilot moved funds between U.S. Bank entities in North America and Europe and demonstrated the potential for 24/7 transactions.

The bank, the fifth-largest commercial lender in the United States, said the deployment ran on @StellarOrg while staying connected to its existing finance, risk, compliance and operations systems. LeapRate reported that U.S. Bank described USBDC as one of the first bank-issued stablecoins deployed on a public blockchain.

An internal treasury transfer, not a client paymentThe transaction was an intra-group movement of funds. Ledger Insights noted that it was not a client payment, which points to corporate treasury and the bank's own liquidity rather than consumer use.

That limits what the result shows. CryptoSlate said both ends of the payment stayed inside U.S. Bank's corporate structure, so the test did not involve settlement with an outside bank, merchant or retail customer.

The bank has not disclosed the amount moved or a commercial rollout date, according to crypto.news. It also did not announce public access to USBDC.

What the pilot testedBeyond the transfer itself, the exercise evaluated several issuer functions. The bank's filing says the pilot validated its internally developed Digital Asset Platform and assessed minting, payment redemption, freezing and clawbacks.

Stellar's own write-up says the effort follows an announcement last November that U.S. Bank was testing custom stablecoin issuance on the network. At that stage, Ledger Insights reported, the bank was building issuance capability rather than running live transactions.

U.S. Bank CEO Gunjan Kedia said the pilot shows the bank can speed up global cash management and money movement for clients within a regulated banking framework, per LeapRate. The bank is exploring liquidity management, collateral mobility and cross-border treasury uses as next steps, crypto.news reported.

For now, the pilot is a proof of concept for how a regulated U.S. bank can use a public network while keeping issuer controls in place, rather than a commercial stablecoin product.

SourcesU.S. Bancorp Form 8-K, third-quarter 2026 earnings release (SEC)
Stellar: A Bank-Issued Stablecoin Moves Real Money on Stellar
Ledger Insights: US Bank completes live cross border pilot of USBDC stablecoin

Southfield, Michigan, Oct. 22, 2026 (GLOBE NEWSWIRE) -- Credit Acceptance Corporation (Nasdaq: CACC) (referred to as the “Company”, “Credit Acceptance”, “we”, “our”, or “us”) announced today that we expect to issue a news release with our third quarter 2026 earnings on Thursday, October 29, 2026, after the market closes. A webcast is scheduled for Thursday, October 29, 2026, at 5:00 p.m. Eastern Time to discuss third quarter 2026 earnings.  

Conference Call and Webcast Information:
Date: Thursday, October 29, 2026
Time: 5:00 p.m. Eastern Time

Telephone Access: 

Only persons accessing the webcast by telephone will be able to pose questions to the presenters during the webcast. To participate by telephone, you must pre-register using the following link:

https://register-conf.media-server.com/register/BIb09f4d3694a2478ba3f752ee48d8fc50

or through the link posted on the “Investor Relations” section of our website at ir.creditacceptance.com. Upon registering you will be provided with the dial-in number and a unique PIN to access the webcast by telephone.

Webcast Access:
The webcast can also be accessed live by visiting the “Investor Relations” section of our website at ir.creditacceptance.com.

Additionally, a replay and transcript of the webcast will be archived in the “Investor Relations” section of our website.

Description of Credit Acceptance Corporation

We make vehicle ownership possible by providing innovative financing solutions that enable automobile dealers to sell vehicles to consumers regardless of their credit history. Our financing programs are offered through a nationwide network of automobile dealers who benefit from sales of vehicles to consumers who otherwise could not obtain financing; from repeat and referral sales generated by these same customers; and from sales to customers responding to advertisements for our financing programs, but who actually end up qualifying for traditional financing.

Without our financing programs, consumers are often unable to purchase vehicles or they purchase unreliable ones. Further, as we report to the three national credit reporting agencies, an important ancillary benefit of our programs is that we provide consumers with an opportunity to improve their lives by improving their credit score and move on to more traditional sources of financing. Credit Acceptance is publicly traded on the Nasdaq Stock Market under the symbol CACC. For more information, visit creditacceptance.com.

Extended, a decentralized exchange built around perpetual contracts, has fully moved to Arc. Trading is live, with USDC and cirBTC as the accepted collateral.

How the move went down The migration took place on October 22, 2026, at 13:00 UTC. Extended shifted its settlement infrastructure from Starknet to Arc, carrying approximately $120 million in total value locked (TVL) with it.

Open positions and orders came along intact. Traders did not need to close out and rebuild their books on the other side.

Deposits and withdrawals did pause briefly during the transition. Both have since been restored.

The collateral menu changed, though. On Arc, Extended now accepts native USDC as its main collateral and cirBTC as its Bitcoin collateral asset.

cirBTC is a token issued by Circle and backed 1:1 by Bitcoin.

Two familiar assets did not survive the trip. USDT and wBTC are not supported on Arc.

Users holding more than $1 of USDT or wBTC had to act by October 21, 2026. They could either withdraw or convert into USDC or cirBTC at a 1:1 rate plus a 0.50% premium.

ETH holders got off easier. Their balances converted automatically to wETH during the migration.

What Arc brings to the table Arc is Circle’s EVM-compatible Layer 1 blockchain. The network launched its mainnet on September 16, 2026. Extended’s arrival comes roughly five weeks later.

Arc offers sub-second deterministic finality. Gas fees on Arc are paid in USDC.

The validator lineup includes founding validators such as BlackRock, DTCC, ICE, Visa, and Mastercard.

Extended also gains access to Circle’s Cross-Chain Transfer Protocol (CCTP). CCTP lets USDC move natively between blockchains, rather than relying on wrapped versions issued by third-party bridges.

The Circle partnership and Extended’s track record The migration is described as the first step in a broader partnership between Extended and Circle.

Extended reports more than $200 billion in lifetime trading volume across multiple asset classes, including traditional stocks and digital currencies.

What this means for traders and the perps market For existing Extended users, the immediate changes are practical. Collateral options narrowed to USDC and cirBTC, and anyone still holding USDT or wBTC had to make a decision before the October 21 deadline.

The 0.50% conversion premium sweetened that deal. Exchanges rarely pay users to switch assets, so the incentive suggests Extended wanted the collateral base consolidated quickly and cleanly.

The things to track from here: whether TVL grows beyond the approximately $120 million that made the trip, how cirBTC adoption develops as Bitcoin collateral, and what the next phase of the Extended and Circle partnership actually delivers.

Disclosure: This article was edited by John Chen. For more information on how we create and review content, see our Editorial Policy.

, /PRNewswire/ -- The J.M. Smucker Co. (NYSE: SJM) today announced its Board of Directors approved a $1.12 per share dividend on the common shares of the Company. The dividend will be paid on Tuesday, December 1, 2026, to shareholders of record at the close of business on Friday, November 13, 2026.

About The J.M. Smucker Co.

At The J.M. Smucker Co., it is our privilege to make food people and pets love by offering a diverse family of brands available across North America. We are proud to lead in the coffee, peanut butter, fruit spreads, frozen handheld, sweet baked goods, dog snacks, and cat food categories by offering brands consumers trust for themselves and their families each day, including Folgers®, Dunkin'®, Café Bustelo®, Jif®, Uncrustables®, Smucker's®, Hostess®, Milk-Bone®, and Meow Mix®. Through our unwavering commitment to producing quality products, operating responsibly and ethically and delivering on our Purpose, we will continue to grow our business while making a positive impact on society. For more information, please visit jmsmucker.com.

The J.M. Smucker Co. is the owner of all trademarks referenced herein, except for Dunkin'®, which is a trademark of DD IP Holder LLC. The Dunkin'® brand is licensed to The J.M. Smucker Co. for packaged coffee products sold in retail channels such as grocery stores, mass merchandisers, club stores, e-commerce and drug stores, and in certain away from home channels. This information does not pertain to products for sale in Dunkin'® restaurants.

SOURCE The J.M. Smucker Co.

, /PRNewswire/ -- Boyd Gaming Corporation (NYSE: BYD) today reported financial results for the third quarter ended September 30, 2026.  

Keith Smith, President and Chief Executive Officer of Boyd Gaming, said, "Our third-quarter performance continued to highlight the benefits of our diversified business model, the ongoing strength of our core customer and the appeal of our property investments nationwide. During the quarter, our results reflected continued growth in our Midwest & South segment, increased play from southern Nevada residents, and strong gains in both our Online and Managed operations. And while quarterly results were impacted by increased softness in destination business to Las Vegas, primarily affecting our Orleans property, we are encouraged by the continued strength of the remainder of our Las Vegas Locals portfolio and the performance of our Midwest & South segment. Finally, we maintained our balanced approach to capital allocation during the third quarter, investing in growth across our portfolio while returning nearly $180 million to our shareholders through share repurchases and dividends. With our robust free cash flow, strong balance sheet and efficient operating model, our Company is well-positioned to continue creating long-term value for our shareholders."

Boyd Gaming reported third-quarter 2026 revenues of $990.5 million, compared to $1.0 billion in the third quarter of 2025. The Company reported net income of $124.9 million, or $1.71 per share, for the third quarter of 2026, compared to $1.4 billion, or $17.81 per share, for the year-ago period. The Company's net income for the third quarter of 2025 benefited from a $1.4 billion after tax gain from the sale of the Company's equity interest in FanDuel, and was impacted by $65.1 million in non-cash, pretax long-lived asset impairment charges.

Total Adjusted EBITDAR(1) was $319.6 million in the third quarter of 2026 versus $321.8 million in the third quarter of 2025. Adjusted Earnings(1) for the third quarter of 2026 were $121.7 million, or $1.67 per share, compared to $139.1 million, or $1.72 per share, for the same period in 2025. 

(1) See footnotes at the end of the release for additional information relative to non-GAAP financial measures.

Operations Review
During the third quarter, results in the Midwest & South segment were impacted by the closure of Sam's Town Tunica in November 2025, the sale of Sam's Town Shreveport in August 2026, and higher property taxes at Kansas Star. Adjusting for these items, Midwest & South revenues increased nearly 3% and Adjusted EBITDAR grew approximately 2.5% during the third quarter. Continued growth in play from core and retail customers and benefits from recent capital investments drove increases in adjusted gaming revenue in the Midwest & South segment. In the Company's Las Vegas Locals segment, results reflected increased softness in Las Vegas destination business, primarily at the Orleans, as well as construction disruption at the Suncoast; however, the remainder of the properties in this segment achieved revenue and Adjusted EBITDAR growth of 3%, with gaming revenue gains of 3.5%, highlighted by increased play from southern Nevada residents. Downtown Las Vegas results were impacted by increased softness in Las Vegas destination business, declines in Hawaiian visitation due to several major storms in Hawaii and higher airfares during the quarter.

The Online segment and Managed & Other both continued to grow during the third quarter. Double-digit Adjusted EBITDAR growth in the Online segment was driven by continued strength in the Company's online casino gaming business.  Growth in Managed & Other reflected increased management fees from Sky River following its recently completed expansion.

Dividend and Share Repurchase Update
Boyd Gaming paid a quarterly cash dividend of $0.20 per share on October 15, 2026, as previously announced.

As part of its ongoing share repurchase program, the Company repurchased $164 million in shares of its common stock during the third quarter of 2026. The Company had $387 million remaining under its current share repurchase authorization as of September 30, 2026.

Balance Sheet Statistics
As of September 30, 2026, Boyd Gaming had cash on hand of $297.2 million, and total debt of $2.7 billion. 

Conference Call Information
Boyd Gaming will host a conference call to discuss its third-quarter 2026 results today, October 22, at 5:00 p.m. Eastern.  The conference call number is (866) 652-5200, passcode 629480.  Please call up to 15 minutes in advance to ensure you are connected prior to the start of the call. 

The conference call will also be available online at https://investors.boydgaming.com or https://app.webinar.net/7XDKZDdZVE2.

Following the call's completion, a replay will be available by dialing (855) 669-9658 today, October 22, and continuing through Thursday, October 29.  The passcode for the replay will be 8824606.  The replay will also be available at https://investors.boydgaming.com.

BOYD GAMING CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

(In thousands, except per share data)

2026

2025

2026

2025

Revenues

Gaming

$             655,026

$             657,371

$          1,988,816

$          1,967,519

Food & beverage

73,744

75,570

227,216

227,895

Room

43,109

45,244

139,469

144,085

Online

33,240

26,893

91,313

106,000

Online reimbursements

121,226

138,704

383,030

402,221

Management fee

27,581

23,697

82,283

72,618

Other

36,529

36,882

110,069

109,586

Total revenues

990,455

1,004,361

3,022,196

3,029,924

Operating costs and expenses

Gaming

262,638

259,660

785,117

765,337

Food & beverage

65,635

67,468

197,530

196,438

Room

19,714

19,486

58,687

57,975

Online

22,044

17,784

60,706

50,392

Online reimbursements

121,226

138,704

383,030

402,221

Other

12,519

13,076

38,191

38,016

Selling, general and administrative

105,370

104,005

326,237

321,916

Master lease rent expense (a)

28,993

28,584

86,433

85,186

Maintenance and utilities

41,078

40,472

115,336

114,519

Depreciation and amortization

91,267

73,749

277,357

211,957

Corporate expense

29,386

30,622

99,413

95,938

Project development, preopening and writedowns

(5,356)

3,972

30,268

5,214

Impairment of assets

—

65,123

—

97,395

Other operating items, net

1,039

1,892

4,299

5,399

Total operating costs and expenses

795,553

864,597

2,462,604

2,447,903

Operating income

194,902

139,764

559,592

582,021

Other expense (income)

Interest income

(1,261)

(1,501)

(4,408)

(3,572)

Interest expense, net of amounts capitalized

33,785

33,262

93,659

132,268

Loss on early extinguishments and modifications of debt

—

1,446

391

1,446

Other, net (b)

89

(1,735,479)

93

(1,735,420)

Total other (income) expense, net

32,613

(1,702,272)

89,735

(1,605,278)

Income before income taxes

162,289

1,842,036

469,857

2,187,299

Income tax provision

(38,699)

(403,200)

(112,051)

(487,227)

Net income

123,590

1,438,836

357,806

1,700,072

Net loss attributable to noncontrolling interest

1,343

1,157

3,903

2,798

Net income attributable to Boyd Gaming 

$             124,933

$          1,439,993

$             361,709

$          1,702,870

Basic net income per common share

$                   1.71

$                 17.81

$                   4.83

$                 20.58

Weighted average basic shares outstanding

73,048

80,860

74,864

82,740

Diluted net income per common share

$                   1.71

$                 17.81

$                   4.83

$                 20.58

Weighted average diluted shares outstanding

73,048

80,875

74,867

82,756

(a) Rent expense incurred by those properties subject to a master lease with a real estate investment trust.

(b) Includes the gain recognized on the sale of the Company's equity interest in FanDuel during the three and nine months ended September 30, 2025.

BOYD GAMING CORPORATION

SUPPLEMENTAL INFORMATION

Reconciliation of Adjusted EBITDA to Net Income Attributable to Boyd Gaming

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

(In thousands)

2026

2025

2026

2025

Total Revenues by Segment

Las Vegas Locals

$             207,449

$             210,842

$             650,451

$             662,732

Downtown Las Vegas

47,423

53,224

154,473

165,764

Midwest & South

540,489

538,852

1,622,472

1,583,516

Online

154,466

165,597

474,343

508,221

Managed & Other

40,628

35,846

120,457

109,691

Total revenues

$             990,455

$          1,004,361

$          3,022,196

$          3,029,924

Adjusted EBITDAR by Segment

Las Vegas Locals

$               87,389

$               92,128

$             293,767

$             311,389

Downtown Las Vegas

12,853

16,118

48,658

56,446

Midwest & South

201,629

201,603

603,018

586,226

Online

10,925

9,424

29,871

54,974

Managed & Other

29,757

26,269

88,865

79,551

Corporate expense, net of share-based compensation expense (a)

(22,924)

(23,777)

(76,667)

(71,442)

Adjusted EBITDAR

319,629

321,765

987,512

1,017,144

Master lease rent expense (b)

(28,993)

(28,584)

(86,433)

(85,186)

Adjusted EBITDA

290,636

293,181

901,079

931,958

Other operating costs and expenses

Deferred rent

141

147

405

441

Depreciation and amortization

91,267

73,749

277,357

211,957

Share-based compensation expense

8,643

8,534

29,158

29,531

Project development, preopening and writedowns

(5,356)

3,972

30,268

5,214

Impairment of assets

—

65,123

—

97,395

Other operating items, net

1,039

1,892

4,299

5,399

Total other operating costs and expenses

95,734

153,417

341,487

349,937

Operating income

194,902

139,764

559,592

582,021

Other expense (income)

Interest income

(1,261)

(1,501)

(4,408)

(3,572)

Interest expense, net of amounts capitalized

33,785

33,262

93,659

132,268

Loss on early extinguishments and modifications of debt

—

1,446

391

1,446

Other, net (c)

89

(1,735,479)

93

(1,735,420)

Total other (income) expense, net

32,613

(1,702,272)

89,735

(1,605,278)

Income before income taxes

162,289

1,842,036

469,857

2,187,299

Income tax provision

(38,699)

(403,200)

(112,051)

(487,227)

Net income

123,590

1,438,836

357,806

1,700,072

Net loss attributable to noncontrolling interest

1,343

1,157

3,903

2,798

Net income attributable to Boyd Gaming 

$             124,933

$          1,439,993

$             361,709

$          1,702,870

(a) Reconciliation of corporate expense:

Three Months Ended

Nine Months Ended

September 30,

September 30,

(In thousands)

2026

2025

2026

2025

Corporate expense as reported on Condensed Consolidated Statements of Operations

$               29,386

$               30,622

$               99,413

$               95,938

Corporate share-based compensation expense

(6,462)

(6,845)

(22,746)

(24,496)

Corporate expense, net, as reported on the above table

$               22,924

$               23,777

$               76,667

$               71,442

(b) Rent expense incurred by those properties subject to a master lease with a real estate investment trust.

(c) Includes the gain recognized on the sale of the Company's equity interest in FanDuel during the three and nine months ended September 30, 2025.

BOYD GAMING CORPORATION

SUPPLEMENTAL INFORMATION

Reconciliations of Net Income attributable to Boyd Gaming to Adjusted Earnings

and Net Income Per Share to Adjusted Earnings Per Share

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

(In thousands, except per share data)

2026

2025

2026

2025

Net income attributable to Boyd Gaming

$             124,933

$          1,439,993

$             361,709

$          1,702,870

Pretax adjustments:

Project development, preopening and writedowns

(5,356)

3,972

30,268

5,214

Impairment of assets

—

65,123

—

97,395

Other operating items, net

1,039

1,892

4,299

5,399

Loss on early extinguishments and modifications of debt

—

1,446

391

1,446

Other, net (a)

89

(1,735,479)

93

(1,735,420)

Total adjustments

(4,228)

(1,663,046)

35,051

(1,625,966)

Income tax effect for above adjustments

953

362,197

(7,578)

354,125

Adjusted earnings

$             121,658

$             139,144

$             389,182

$             431,029

Net income per share, diluted

$                   1.71

$                 17.81

$                   4.83

$                 20.58

Pretax adjustments:

Project development, preopening and writedowns

(0.07)

0.05

0.40

0.06

Impairment of assets

—

0.80

—

1.18

Other operating items, net

0.02

0.02

0.06

0.06

Loss on early extinguishments and modifications of debt

—

0.02

0.01

0.02

Other, net (a)

—

(21.46)

—

(20.97)

Total adjustments

(0.05)

(20.57)

0.47

(19.65)

Income tax effect for above adjustments

0.01

4.48

(0.10)

4.28

Adjusted earnings per share, diluted

$                   1.67

$                   1.72

$                   5.20

$                   5.21

Weighted average diluted shares outstanding

73,048

80,875

74,867

82,756

(a) Includes the gain recognized on the sale of the Company's equity interest in FanDuel during the three and nine months ended September 30, 2025.

Non-GAAP Financial Measures
Our financial presentations include the following non-GAAP financial measures:

EBITDA: earnings before interest, taxes, depreciation and amortization, Adjusted EBITDA: EBITDA adjusted for deferred rent, share-based compensation expense, project development, preopening and writedowns expense, impairments of assets, other operating items, net, gain or loss on early extinguishments and modifications of debt, net income (loss) attributable to noncontrolling interest and other items, net, as applicable, EBITDAR: EBITDA further adjusted for rent expense associated with master leases with a real estate investment trust, Adjusted EBITDAR: Adjusted EBITDA further adjusted for rent expense associated with master leases with a real estate investment trust, Adjusted Earnings: net income before project development, preopening and writedowns expense, impairments of assets, other operating items, net, gain or loss on early extinguishments and modifications of debt, net income (loss) attributable to noncontrolling interest, and other non-recurring adjustments, net, as applicable, and, Adjusted Earnings Per Share (Adjusted EPS): Adjusted Earnings divided by weighted average diluted shares outstanding. Collectively, we refer to these and other non-GAAP financial measures as the "Non-GAAP Measures." 

The Non-GAAP Measures are commonly used measures of performance in our industry that we believe, when considered with measures calculated in accordance with accounting principles generally accepted in the United States (GAAP), provide our investors with a more complete understanding of our operating results and facilitates comparisons between us and our competitors. We provide this information to investors to enable them to perform comparisons of our past, present and future operating results and as a means to evaluate the results of core on-going operations. We have historically reported these measures to our investors and believe that the continued inclusion of the Non-GAAP Measures provides consistency in our financial reporting. We also believe this information is useful to investors in allowing greater transparency related to significant measures used by our management in their financial and operational decision-making, their evaluation of total company and individual property performance, in the evaluation of incentive compensation and in the annual budget process. Management also uses Non-GAAP Measures in the evaluation of potential acquisitions and dispositions. We believe these measures continue to be used by investors in their assessment of our operating performance and the valuation of our company.

The use of Non-GAAP Measures has certain limitations. Our presentation of the Non-GAAP Measures may be different from the presentation used by other companies and therefore comparability may be limited. While excluded from certain of the Non-GAAP Measures, depreciation and amortization expense, interest expense, income taxes and other items have been and will be incurred. Each of these items should also be considered in the overall evaluation of our results. Additionally, the Non-GAAP Measures do not consider capital expenditures and other investing activities and should not be considered as a measure of our liquidity. We compensate for these limitations by providing the relevant disclosure of our depreciation and amortization, interest and income taxes, capital expenditures and other items both in our reconciliations to the historical GAAP financial measures and in our consolidated financial statements, all of which should be considered when evaluating our performance. We do not provide a reconciliation of forward-looking Non-GAAP Measures to the corresponding forward-looking GAAP measure due to our inability to project special charges and certain expenses.

The Non-GAAP Measures are to be used in addition to and in conjunction with results presented in accordance with GAAP. The Non-GAAP Measures should not be considered as an alternative to net income, operating income, or any other operating performance measure prescribed by GAAP, nor should these measures be relied upon to the exclusion of GAAP financial measures. The Non-GAAP Measures reflect additional ways of viewing our operations that we believe, when viewed with our GAAP results and the reconciliations to the corresponding historical GAAP financial measures, provide a more complete understanding of factors and trends affecting our business than could be obtained absent this disclosure. Management strongly encourages investors to review our financial information in its entirety and not to rely on a single financial measure.

Forward-looking Statements and Company Information
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as "may," "will," "might," "expect," "believe," "anticipate," "could," "would," "estimate," "continue," "pursue," or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company's expectations, goals or intentions regarding future performance. These forward-looking statements are based on the current beliefs and expectations of management and involve risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Many of these risks and uncertainties relate to factors that are beyond Boyd Gaming's ability to control or estimate precisely. Additional factors that could cause actual results to differ are discussed under the heading "Risk Factors" and in other sections of the Company's Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and in the Company's other current and periodic reports filed from time to time with the SEC. The reader is cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. All forward-looking statements in this press release are made as of the date hereof, based on information available to the Company as of the date hereof, and the Company assumes no obligation to update any forward-looking statement.

About Boyd Gaming
Founded in 1975, Boyd Gaming Corporation (NYSE: BYD) is a leading geographically diversified operator of 26 gaming entertainment properties in 11 states. The Company also manages a tribal casino in northern California, and owns and operates Boyd Interactive, a B2B and B2C online casino gaming business. Boyd Gaming's nationwide portfolio is connected through Boyd Rewards, recognized as the nation's favorite casino loyalty program by readers of both USA Today and Newsweek.  Named by Forbes and Time magazines as one of "America's Best Companies," and led by one of the most experienced teams in the industry, Boyd Gaming is dedicated to delivering an outstanding entertainment experience and memorable guest service. For additional Company information and press releases, visit https://www.boydgaming.com.

SOURCE Boyd Gaming Corporation

Zcash Foundation has released Zebra 7.0.0 with NU7 mainnet support, telling node operators to upgrade before block 3,543,405, expected around Nov. 5.

Summary

Mainnet operators must upgrade before activation to remain on the consensus chain.
Zebra 6.4.x releases are scheduled to stop operating days before the upgrade.
NU7 introduces 25-second blocks while preserving the scheduled daily issuance of ZEC.
The foundation says Zebra 7.0.0 includes fixes for five security advisories.

Zcash Foundation said in its Oct. 22 announcement that mainnet operators must install the upgrade to remain on the consensus chain, while older 6.4.x releases will stop themselves days before activation.

“All Mainnet operators MUST upgrade before height 3,543,405 (~Nov 5) to stay on the consensus chain.”

The foundation listed 25-second blocks, a Network Sustainability Mechanism, and fixes for five security advisories among the release’s features.

Zebra operators face an earlier shutdown
The foundation’s Oct. 6 engineering update put the expected shutdown of Zebra 6.4.x around Nov. 2. Developers shortened the software’s operating period from 15 weeks to 12 weeks to bring that halt ahead of the planned network upgrade.

In the same update, the engineering team said expiry calculations and synchronization estimates had been adjusted to follow the block time in effect at each height. Without that adjustment, faster block production could make software stop earlier than intended.

NU7 reached public testnet at block 4,465,026 on Oct. 4, the foundation confirmed. The testnet activation introduced the consensus changes for observation before mainnet deployment.

As crypto.news previously reported on Oct. 21, developers had selected the mainnet activation height after an Oct. 20 meeting of ZIP editors. At that reporting cutoff, the change still awaited integration into the deployment specification.

The current ZIP 259 text now lists mainnet block 3,543,405. Its compatibility rules say upgraded nodes will disconnect peers advertising an older network protocol version after activation.

The specification warns that unsupported software can remain online and follow a pre-NU7 consensus branch. It does not establish how many operators are still using incompatible software.

Zcash targets faster confirmations without faster issuance
ZIP 218 sets the new block target at 25 seconds, down from 75 seconds. Its authors identify payments, exchange deposits, and cross-chain operations as uses affected by the wait for confirmations.

The proposal does not advise clients to cut their confirmation counts. Its discussion of rollback risk distinguishes between security models, including models based on an attacker’s share of mining power and those based on the economic cost of reversing a payment.

The foundation’s Oct. 2 release-candidate explanation says daily scheduled issuance stays unchanged because the software divides scheduled block rewards by three and adjusts the remaining halving intervals.

Its description retains the four-year halving schedule and the 21 million ZEC supply cap. Faster block production therefore does not mean the scheduled daily mining subsidy triples.

The September coinholder poll recorded roughly 99.9% support for shorter block spacing and 98.9% support for preserving halvings. Nearly 2.4 million ZEC participated, representing around 66% of eligible Ironwood balances at the snapshot, according to the published results covered on Sep. 16.

Voting closed on Sep. 14 after balances were recorded at mainnet block 3,459,350 on Aug. 24. Eligibility depended on spendable shielded funds held in Ironwood at that snapshot.

NU7 redirects fees into future mining rewards
The foundation’s release-candidate explanation describes a split in which 60% of transaction fees leave circulation for a reserve, while miners keep the remaining 40%.

Under the Network Sustainability Mechanism, the reserved funds can return gradually through future block rewards. The Oct. 21 activation coverage identified mainnet block 8,939,664 for the start of reissuance, expected around February 2031.

Coinholders had favored that timing with approximately 96.6% support in September’s poll. The deployment specification lists the reissuance height separately from the NU7 activation height.

The Oct. 2 technical explanation gives mining pools a related instruction. Because a coinbase transaction depends on selected transaction fees and the parent block’s reserve, miners should request a fresh block template instead of changing its transaction set or previous block themselves.

The foundation described shielded activity limits covering individual pools and a shared budget across pools. Its engineering update says those restrictions are designed to protect light wallets from spam while the network produces blocks more frequently.

ZIP 218 places the shared shielded budget at 330 actions per block, alongside separate pool limits. Its authors estimate that the changes cut worst-case daily light-wallet synchronization bandwidth from 271 megabytes to 169 megabytes, a reduction of roughly 37%.

The proposal notes a separate privacy trade-off. More frequent blocks give observers finer timing information, which can be combined with observations from networks or applications. Its authors say the new limits do not prevent traffic analysis or eliminate denial-of-service risk.

Sprout funds face a separate spending deadline
The Oct. 5 testnet coverage described another NU7 change affecting funds in Sprout, Zcash’s original shielded pool. Disabling version 4 transactions prevents spending those funds after activation unless holders move them beforehand.

ZIP 259 specifies that the prohibition applies to every version 4 transaction, including transparent-only and Sapling transactions. Saved transactions signed offline require the same activation checks.

The specification says versions 5 and 6 keep their existing structures, but their signatures commit to a consensus branch identifier. An unchanged transaction format does not guarantee a transaction remains valid across activation.

, /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:

Cannot view this video? Visit:
https://www.youtube.com/watch?v=DZQWREfFVIM

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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RedStone has integrated Filecoin and deployed a FIL/USD push price feed on Filecoin mainnet, delivering a dollar price for the network’s native token to smart contracts on the Filecoin Virtual Machine (FVM).

How the FIL/USD Price Feed Works on Filecoin Mainnet RedStone’s FIL/USD feed publishes a signed FIL price to a contract on Filecoin mainnet that any FVM application can read. Getting there took a chain integration: RedStone set up the relayer and onchain contracts Filecoin needed to receive push feeds in the first place.

The feed runs on RedStone’s push model. An off-chain relayer collects FIL prices from RedStone’s data providers and writes an update onchain when one of two conditions is met, a 0.5% price deviation or a four-hour heartbeat. Each update carries the providers’ signatures and a timestamp, and the adapter contract validates both before storing the price. Consuming contracts read that stored value directly.

Because the FVM runs Solidity through its EVM runtime, integration looks the same as it does on Ethereum. A lending contract calls latestRoundData() through the standard aggregator interface and gets back the price along with the time it was last updated. The Calibration feed lets teams test collateral and liquidation logic against real FIL prices before any mainnet funds are involved.

Why FVM Applications Need a Dollar Price for FIL Much of Filecoin’s DeFi activity grew out of storage. Providers lock FIL as collateral to take on storage deals, and protocols such as GLIF run leasing pools where FIL holders deposit tokens, receive a liquid token in return, and lend to those providers for a share of their rewards. The loans are denominated in FIL. The decisions around them, how much a provider can borrow and when a position gets too thin, depend on what FIL is worth in dollars on a given day.

The programmable side of the network is growing as well. Filecoin Onchain Cloud, which moves storage and payments onchain, went live on Filecoin mainnet on 26 March 2026 after more than 100 teams built on its testnet, according to the Filecoin blog. Its payment layer, Filecoin Pay, settles usage onchain, and the network’s 2026 strategy calls for adding stablecoin payments to it. Once storage is priced in dollars and paid in FIL, or the reverse, the contract in the middle needs a conversion rate it can trust, updated often enough to settle against.

What the Integration Unlocks For Filecoin builders, the change is practical. A team launching a FIL-collateralized lending market or a dollar-priced storage service can point its contract at an existing feed and skip running price infrastructure of its own. The same reference price is a starting input for liquid staking tokens that need a dollar value, for insurance products that price cover in dollars and pay out in FIL, and for AI and data applications that bill for services onchain. Where those products need something beyond FIL/USD, such as an exchange rate for a liquid token, RedStone’s custom feeds can be deployed on the same infrastructure.

For RedStone, the integration extends its footprint into the network that describes itself as the world’s largest decentralized storage network, and into a DeFi market built around provider collateral. Chain integrations tend to widen after launch. RedStone went live on Tempo in March 2026 with FX feeds for payments, and by May it was supplying the feeds behind a full lending stack on Tempo. The feeds also carry a record of zero mispricing events, including correct ezETH and wstETH prices during episodes when those assets were mispriced elsewhere.

Filecoin’s 2026 network strategy puts paid onchain deals at the top of its objectives, alongside network profitability and adoption by paying flagship clients. Its go-to-market focus includes AI agents, chain data and real-world assets. Each paid deal is a contract that moves FIL, and every one budgeted in dollars needs a price to settle against.

See the FIL/USD feed’s contract addresses and update parameters on the RedStone app.

Is there a FIL/USD price feed on Filecoin mainnet? Yes. RedStone operates a FIL/USD push feed on Filecoin mainnet that any smart contract on the Filecoin Virtual Machine can read. A matching feed runs on the Calibration testnet for development and testing.

How often does the RedStone FIL/USD feed update? The feed pushes a new price onchain whenever FIL moves 0.5% from the last stored value. If the price stays inside that band, a heartbeat forces an update every four hours.

How do FVM smart contracts read the FIL/USD price? The FVM supports Solidity, so contracts read the feed with latestRoundData(), which returns the latest price and its update timestamp. The mainnet relayer contract sits at 0x434F8D17c0301cfEa143dba912972E24B827C968, and addresses for both networks are listed on the RedStone app.

Can RedStone deploy other price feeds on Filecoin? Yes. The chain integration means the relayer and contracts are already in place on Filecoin, so teams can request additional feeds from the RedStone team.

RedStone is the data layer for institutional DeFi, delivering secure, low-latency price feeds for digital assets, RWAs, stablecoins, LSTs, LRTs, and Bitcoin LSTs across 110+ chains. Trusted by 200+ clients, including Securitize, Morpho, Pendle, Spark, Ether.fi, Ethena, Lombard, Venus, and Compound, RedStone powers lending, stablecoins, perpetuals, and tokenized asset markets with custom pricing infrastructure built for complex onchain systems. RedStone provides data for tokenized products including BlackRock’s BUIDL, Apollo ACRED, and Hamilton Lane SCOPE. Zero mispricing events. 100% uptime. Learn more at redstone.finance.

Filecoin is a peer-to-peer network to store files, with built-in economic incentives to ensure files are stored reliably over time. It’s designed to create a decentralized, efficient, and robust foundation for humanity’s information. Learn more at filecoin.io.

AVAX is testing the lower boundary of a falling wedge at key Fibonacci support.
A death cross on the 4-hour chart keeps the rebound unconfirmed.
Charles Schwab calls Avalanche a leader in institutional blockchains and RWA tokenization.
The broker warns that institutional adoption may not translate into demand for AVAX.

AVAX price is trading near $9.21 on the 4-hour chart, sitting on its most important support zone at $9.00-$9.20 after a 23% pullback from the late-September high of $12.01, with a falling wedge pattern set to resolve within days. The test comes as Charles Schwab, the brokerage with roughly $13 trillion in client assets, published an analysis of Avalanche and Chainlink on October 20 that names Avalanche a leader in institutional blockchains and real-world asset (RWA) tokenization, while questioning whether that position will ever translate into demand for the token.

JUST IN: Charles Schwab identifies Avalanche as a leader in RWAs and institutional use cases.

New research from @CharlesSchwab points to custom L1s and high-utility financial activity as key differentiators for the network. pic.twitter.com/vLhdjuebkL

— Avalanche🔺 (@avax) October 21, 2026

A rally on volume, a pullback without it
Between September 17 and September 29, AVAX rallied nearly 68% in just over 12 days, climbing from $7.17 to $12.01. Over the following 23 days it gave back more than 23% of its value. Total volume was almost identical in both phases, about 84.8 million AVAX in the rally and 83.6 million in the correction, but the decline lasted nearly twice as long, so average volume per candle during the pullback is roughly half of what it was on the way up. Sellers have been pushing price lower with fading participation, a pattern that tends to accompany a correction more often than a trend reversal.

A falling wedge at the 0.618 level
AVAX/USDT 4H chart. Source: Alexander Stefanov on TradingView
Since early October, price has compressed into a falling wedge, a pattern of two converging downward lines in which each high is lower than the last ($11.70, $11.00, $10.50, $9.95) while the lows drop by shrinking steps. AVAX is now testing the wedge’s lower boundary just above $9.02, the level where price would retrace 61.8% of the September rally and where pullbacks within strong trends often stall. That overlap makes $9.00-$9.20 the decisive support on the chart, and the wedge’s apex falls around October 26-27.

The death cross and the $9.90 wall
The 50-period exponential moving average ($9.79) has just slipped below the 200-period average ($9.90), which in practice means the average price of roughly the last eight days is now lower than the average of the past month. On October 21, AVAX attempted a breakout but was rejected exactly at the upper wedge line, where both averages also sit, turning $9.80-$9.90 into a dense resistance cluster.

The Relative Strength Index (RSI) stands at 35, close to the 30 mark below which the market is considered oversold, and remains under its signal line at 45. The indicator’s lows have stayed roughly flat while price kept printing lower lows, a mild bullish divergence that still lacks confirmation.

Level
Price
Role

Top of the wedge
$11.50-$11.70
Breakout target

Fibonacci 0.382
$10.16
Resistance

Wedge line and EMAs
$9.80-$9.90
Key resistance

Fibonacci 0.5
$9.59
Support after breakout

Fibonacci 0.618
$9.00-$9.20
Key support

Fibonacci 0.786
$8.20
Breakdown target

Levels from the AVAX/USDT 4-hour chart on Binance as of October 22.

What Schwab sees in Avalanche
Analysts at the Schwab Center for Financial Research do not put Avalanche in a head-to-head fight with Ethereum or Solana for overall dominance. They describe it as infrastructure on which banks, funds and companies build their own blockchains, with access rules, fees and compliance settings tailored to their needs. The report credits the network with capacity above 4,500 transactions per second, an activity mix led by stablecoins, lending, asset management and liquid staking, and favorable tokenomics thanks to the 720 million maximum supply and the burning of every transaction fee.

$3.4B

Total value locked, fifth among smart contract chains

< $2B

Tokenized RWAs on Avalanche

~$50B

Total tokenized RWA market

200x-1,200x

AVAX value vs. three years of network fees

Source: Charles Schwab, August-September 2026 data.

Why the institutional story may not lift AVAX
The sharpest argument in the report targets Avalanche itself. An institution that launches its own chain can run nearly all of its activity outside the primary network, and those transactions do not generate the burned fees that create demand for AVAX. Tokenized bonds and funds also change hands rarely, so even a large volume of issuance can produce little fee revenue.

Schwab values the network through a kind of network “GDP”, meaning the economic activity users actually pay for. On that basis, AVAX carries a market value between 200 and 1,200 times the fees collected over the past three years, comparable to an extremely high price-to-earnings multiple in equities, and those fees have been declining since 2023. Avalanche also holds less than 4% of the tokenized asset market, where Ethereum controls a far larger share.

The research is separate from Schwab’s August 27 decision to add SOL, AVAX and LINK to Schwab Crypto “in the coming months”, which will give the broker’s clients access to AVAX trading at a 0.75% fee per trade. The listing concerns trading access only and does not mean Schwab uses Avalanche for its own settlement or tokenization.

The wedge resolves by October 27
To cancel the death cross signal, AVAX price needs a 4-hour close above the wedge and the moving averages at $9.80-$9.90. That would flip $9.59 into support, put the next resistance at $10.16, and leave the pattern’s measured move pointing back toward $11.50-$11.70. A decisive close below $9.00 would break both the wedge and the 0.618 level, opening the way toward $8.20, which also lines up with the early-September highs.

A falling wedge on declining volume, resting on the 0.618 level after a strong impulse, more often ends with a continuation of the prior rally, so the structure leans slightly in favor of buyers. The death cross and the rejection at the averages show the bounce is not confirmed, and until AVAX reclaims $9.90, the $9.00 support decides the direction.

Beyond the next few sessions, two catalysts sit outside the chart. Schwab has not set a launch date for AVAX trading and has reserved the right to delay or change its plans, while daily fees on Avalanche’s primary network, the weak spot the report singles out, are public data that will show whether institutional interest starts turning into real demand for the token.

Alex is a financial markets journalist and co-founder of Millennial Media Group, and he's spent close to ten years trying to answer one stubborn question: what's really driving this?
It started in 2016, when Bitcoin refused to make sense to him - and rather than shrug, he stayed with it until it did. That patience became his method. He's less interested in what an asset is doing today than in the plumbing behind it: how liquidity flows, where risk hides, what a chart is quietly telling you that the headline isn't. That lens eventually stretched well past crypto into traditional markets, because the same forces - fear, leverage, incentives, timing - show up everywhere once you know how to look.
Most coverage, in his view, insults the reader by stopping at the surface. Price up, price down, moving on. He'd rather leave someone genuinely understanding a move than merely informed that it happened.
His path into markets ran through a Tourism degree at New Bulgarian University - proof, maybe, that curiosity beats credentials. With more than 200 deep analyses and over 10,000 articles behind him, he still walks away from most trading days having learned something he didn't know that morning.

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Avalanche’s decentralized exchange (DEX) activity has seen a significant increase, with 30-day trading volume rising to $4.1 billion in October 2026, marking a 29% month-over-month gain. This growth comes amid a broader decline in DEX volume across other major Layer-1 blockchain networks, positioning Avalanche as a notable outlier capturing greater trading market share during the period.

Pharaoh Exchange dominance and concentrated liquidityThe recent momentum within Avalanche’s DEX sector is highly concentrated among a few platforms. Pharaoh Exchange, an automated market maker with specialized liquidity solutions, accounts for roughly $3.12 billion, or 76%, of Avalanche’s total DEX trading volume. According to DeFiLlama, the platform achieved this dominance with just $43 million to $53 million in total value locked (TVL), signaling a turnover ratio far higher than traditional constant-product market makers.

Uniswap and LFJ also posted strong performance. Uniswap’s trading volume on Avalanche surged 95% to $392 million, while LFJ’s volume climbed 165% to $201 million, both benefiting from heightened attention to concentrated liquidity design and adaptable fee structures.

Collectively, the three leading DEXs now account for more than 89% of Avalanche’s entire DEX trading activity, resulting in deeper liquidity pools capable of accommodating larger trades and minimizing slippage for both traders and liquidity providers.

DEX PlatformVolume (30 days)Change (%)Share of Avalanche DEX VolumePharaoh Exchange$3.12 billionN/A76%Uniswap$392 million+95%9.5%LFJ$201 million+165%4.9%For developers, rising DEX throughput frequently spurs increased lending, bridging, and related derivatives activity across the platform.

Technical drivers and capital efficiencyPharaoh Exchange’s remarkable efficiency relies on the V3 and DLMM (Dynamic Liquidity Market Maker) protocols. DLMM enables liquidity providers to target their capital within specific price ranges, maximizing fees per dollar locked. This mechanism has reportedly been customized for Avalanche’s infrastructure, making use of the chain’s low fees and high throughput.

However, while active market makers can benefit from this model, passive liquidity suppliers may face elevated risks, such as impermanent loss if their chosen price ranges prove suboptimal. Furthermore, the heavy concentration of activity on Pharaoh raises concerns about a single point of failure in network liquidity, as reliance on its infrastructure becomes more pronounced.

Mini dictionary: DLMM (Dynamic Liquidity Market Maker) is a protocol that allows liquidity providers to set capital allocations for specific price bins, dynamically optimizing for market conditions. This design maximizes capital efficiency but introduces complexity compared to traditional market makers.

Broader DeFi implications and future risksThe DEX sector’s momentum on Avalanche aligns with industry-wide adoption of concentrated liquidity mechanics, first popularized by Uniswap V3 in 2021. Avalanche’s ability to offer high throughput and low transaction costs has made it a favored network for stablecoin settlements and tokenized asset trading.

A core strength of the current ecosystem is the depth of liquidity, attracting aggregators, integrations, and external incentives. Yet this same concentration increases potential vulnerabilities, exposing the network to governance disputes, fee allocation challenges, and heightened resilience risks should a leading protocol encounter issues.

With volume highly concentrated, a single exploit impacting a dominant DEX such as Pharaoh could significantly disrupt the broader Avalanche network’s liquidity and market confidence.

For investors and institutional participants, sustained DEX activity reflects differences in how Layer-1 ecosystems compete beyond simple transaction volumes. Observers point to indicators such as ongoing fee generation and user retention as signals of lasting DeFi growth, rather than temporary trading patterns.

For DEX operators on other blockchains, Avalanche’s experience highlights the impact of capital efficient models and platform specialization. While Pharaoh currently leads the market, competitors like Uniswap and LFJ are gaining ground. Whether the upward trend continues may depend on evolving incentive schemes, market volatility, and users’ willingness to remain engaged with Avalanche-based DeFi services.

Solana has promoted Quantumglow, a proposed post-quantum adaptation of Alpenglow designed to protect consensus while preserving the network’s fast finality.

Summary

Quantumglow proposes changes to validator signatures and block authentication without announcing a deployment date. Anza published the underlying research in July, before Solana’s latest video explainer. Alpenglow’s mainnet activation is separate from the proposed post-quantum changes to its cryptography. Bitcoin’s BIP-360 targets exposed public keys, with additional signatures needed for more complete protection. Solana Developers described the proposal in an Oct. 22 video post, presenting it as a way to secure agreement between validators against quantum attacks. Solana’s main account shared the explainer and said the network “has been early in quantum readiness and remains ahead in its preparation.”

What would Solana’s consensus look like in a post-quantum world?

Meet Quantumglow: a proposed adaptation of Alpenglow that aims to protect consensus while preserving fast finality.@jacobvcreech and @qkniep explain how it works. Full video below👇 pic.twitter.com/G005a4KcSI

— Solana Developers (@solana_devs) October 22, 2026 Neither announcement supplied an activation date or identified a Quantumglow-specific Solana Improvement Document, known as a SIMD. The developer post described an adaptation under proposal, without announcing a deployed security upgrade.

The research predates the latest explainer. Anza published its Quantumglow overview on July 30, naming Quentin Kniep, Kobi Sliwinski and Roger Wattenhofer as its authors and directing readers to Section 5 of the updated Alpenglow whitepaper.

Quantumglow changes how validators authenticate agreement Anza’s July overview identifies two obstacles to replacing Alpenglow’s existing cryptography. Post-quantum signatures take more space, while the compact signature aggregation used to prove validator agreement has no comparable ready replacement under the researchers’ requirements.

The authors propose Ax, short for Alpenglow XMSS, a hash-based signature scheme tailored to the protocol. Validators would exchange and cache one-time public-key material ahead of use, reducing the information that must accompany later signatures.

For block authentication, Anza describes a signed commitment covering the block payload, supported by authenticated communication channels. Its design removes the need to attach a large post-quantum signature to every piece of block data.

The accompanying distributed-quorum-signature research explains the second change. Kniep, Jakub Sliwinski and Wattenhofer describe moving certificates from messages sent across the network to events recorded locally after a node gathers enough evidence.

Their paper, submitted July 20, uses ordinary signatures and an approval-broadcast mechanism. It separates evidence supporting safety from evidence supporting liveness, the protocol’s ability to keep making progress.

The researchers say each message remains a constant size regardless of node count, although total communication grows quadratically. Their performance claim concerns the proposed design and its stated assumptions, without establishing a measured mainnet result.

Solana’s Alpenglow rollout has a separate activation record Solana Foundation’s upgrade page identifies Alpenglow as live on mainnet following activation in epoch 1064 on Oct. 21. The Foundation lists approximately 150 milliseconds as its finality target, compared with 12.8 seconds for TowerBFT.

The Foundation records Alpenglow consensus beginning at slot 459,653,000, after a genesis block certified by votes from 446 of 654 validators. Its documentation separates the deployed Votor voting system from Rotor, a data-distribution component reserved for a later release.

Before that handoff, crypto.news previously reported the planned consensus migration and its operator requirements. The Oct. 19 coverage documented the need for compatible validator software and sufficient vote-account funding.

SIMD-0326 specifies the Votor portions of Alpenglow and references version 1.1 of its whitepaper. The proposal explicitly leaves Rotor for a separate SIMD, showing that the original consensus specification does not cover every component discussed in subsequent research.

Solana Foundation says Alpenglow leaves transaction execution, programs, and transaction fee mechanics unchanged. Its migration guidance states that ordinary users do not need to change how they sign, send, or approve transactions.

The removal of on-chain votes creates separate changes for analytics services. As detailed in Oct. 20 coverage of vote-transaction removal, the Foundation instructs explorers to reset metrics that counted validator votes alongside user transactions.

Wallet protection requires work beyond consensus Anza’s April 27 security assessment identifies distinct quantum vulnerabilities in accounts, block propagation, consensus, and user-defined programs. Max Resnick and Sam Kim warn that an attacker capable of breaking Ed25519 could forge account signatures, while forged consensus votes could support conflicting confirmations.

Their checklist calls for work on account migration, transaction signature verification, networking and program-level cryptographic tools. The assessment makes no commitment to a single post-quantum signature scheme.

Early Falcon implementations formed another part of that preparation. April 28 coverage documented Anza and Firedancer testing the signature technology, with the teams describing it as an option for possible future activation.

Anza’s assessment describes a prototype migration proof that binds an existing account to a new post-quantum public key. The authors distinguish such account migration from optional vault programs, which cannot independently secure consensus, networking, or every application using vulnerable signatures.

Bitcoin’s BIP-360 addresses exposed keys Bitcoin’s BIP-360 specification proposes Pay-to-Merkle-Root outputs through a soft fork, removing the key-path spending option used by Taproot. Its authors describe protection against attacks on public keys exposed for long periods.

The draft explicitly separates that protection from attacks conducted while a spending transaction waits for confirmation. Its authors say protection against those shorter exposures may require post-quantum signatures through a separate proposal.

BIP-360’s motivation describes quantum key recovery as deriving a private key from a public key by breaking the discrete logarithm assumption. The authors say the timing and eventual viability of a cryptographically relevant quantum computer remain unclear. Their proposal does not set a date when such an attack becomes practical or establish that present hardware can perform it.

The repository lists BIP-360 as a draft authored by Hunter Beast, Ethan Heilman, and Isabel Foxen Duke. Its abstract states that the proposed output type retains script-tree functionality while removing the quantum-vulnerable key-path spend.

J.P. Morgan Asset Management has brought two tokenized money market funds, MONY and JLTXX, to Solana for qualified U.S. investors through its Morgan Money platform.

Summary

MONY and JLTXX give qualified U.S. investors access to tokenized fund shares on Solana.
MONY’s existing FAQ lists a $1 million initial investment minimum and offchain shareholder records.
JLTXX’s May prospectus requires approved wallet addresses for purchases, redemptions and token transfers.
BlackRock and Franklin Templeton brought their tokenized funds to Solana in 2025.

J.P. Morgan Asset Management said investors can subscribe and redeem through Morgan Money, with token balances sent to their blockchain addresses.

“Our clients operate across more than one network, and their liquidity should too,” said Paul Przybylski, the firm’s global head of product, digital and tokenized assets.

JPMorgan’s MONY fund carries a $1 million entry minimum
JPMorgan’s MONY FAQ lists an initial investment minimum of $1 million and fees of 16 basis points. The document describes a private placement fund domiciled in the British Virgin Islands, with investor onboarding subject to anti-money laundering and know-your-customer checks.

The FAQ says MONY holds U.S. Treasury securities and Treasury-backed repurchase agreements. Its investment guidelines seek a stable $1 net asset value, with Treasury purchases limited to securities with no more than 93 days remaining or issued with maturities of 93 days or less.

Although MONY intends to follow investment guidelines for government money market funds, JPMorgan’s FAQ says the private vehicle is not subject to Rule 2a-7. The document identifies SS&C as the transfer agent and says the official shareholder records remain offchain.

Earlier coverage documented JPMorgan’s $100 million seed investment when MONY launched on Ethereum in December 2025. As crypto.news previously reported, the fund formed part of the bank’s move into public blockchain infrastructure through its Kinexys business.

JPMorgan’s FAQ says investors need their own blockchain address to hold MONY tokens. It permits direct token interactions for transfers and transaction requests, while describing peer-to-peer transfers as restricted to clients. The document predates the Solana expansion and does not establish every operational detail of the new deployment.

The December report described institutional cash management as the product’s intended use. Its $100 million figure referred to initial internal capital, not the amount now held on Solana or MONY’s current total assets.

JLTXX’s filing sets out approved-wallet controls
JPMorgan’s JLTXX filing in May described a registered government money market fund built for stablecoin reserve management. The prospectus dated May 13 listed Ethereum as its only available public network at that time and anticipated support for other blockchains.

The same document required approved addresses before investors could buy, redeem or transfer token balances. Its blockchain framework uses an allow list, restricting transactions to participants approved by the fund.

JLTXX’s prospectus says the transfer agent’s investor register determines legal share ownership. Token balances are intended to correspond to shares, but the document warns that the two records may temporarily differ when blockchain instructions arrive outside business days.

The filing lists a $1 million opening minimum, with no minimum for subsequent purchases, and permits investment minimum waivers. Annual operating expenses after waivers and reimbursements are listed at 0.16%, with those arrangements scheduled through June 30, 2028.

A separate section describes optional services for converting USDC into dollars before purchases and converting redemption proceeds back into USDC. The May coverage noted that Circle is not affiliated with the fund, its adviser or Kinexys.

JPMorgan’s Oct. 22 release describes JLTXX as designed to support stablecoin issuers under the GENIUS Act. It does not disclose current assets for either fund or announce a decentralized lending integration.

BlackRock brought BUIDL to Solana in March 2025
BlackRock’s BUIDL expansion to Solana occurred in March 2025 through Securitize, giving the fund a seventh supported network at the time. The other six were Ethereum, Aptos, Arbitrum, Optimism, Avalanche, Polygon.

Securitize’s launch announcement described a new Solana share class for the BlackRock USD Institutional Digital Liquidity Fund. The company said BUIDL invests in cash, U.S. Treasury bills and repurchase agreements.

The March coverage identified Copper, Anchorage Digital and Fireblocks among BUIDL’s custody providers. It placed the fund’s value at $1.7 billion at that point, a historical figure covering the product rather than its Solana deployment alone.

Franklin’s BENJI uses blockchain-integrated ownership records
Franklin Templeton added Solana support in February 2025 for its Franklin OnChain U.S. Government Money Fund. The earlier deployment report listed Stellar as its original network, followed by expansions across Aptos, Ethereum, Avalanche, Arbitrum, Base and Polygon.

Franklin’s current Benji platform describes one BENJI token as representing one share of the fund, which trades under the FOBXX ticker. Its transfer agent maintains the official ownership record through a proprietary system integrated with public blockchains.

The company’s fund page says at least 99.5% of assets go into government securities, cash and fully collateralized repurchase agreements. It lists daily dividend frequency and an April 6, 2021, inception date.

Effective May 18, 2026, Franklin’s fund page lists Western Asset Management as a new sub-adviser responsible for day-to-day portfolio management. The same notice says the fund normally calculates net asset value hourly from 8 a.m. Eastern until its business-day close and intends to declare and reinvest income dividends daily.

Franklin’s platform timeline records the launch of peer-to-peer transfers for retail investors through its redesigned mobile app in May 2025.

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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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.