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

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

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

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

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

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

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

Pricing opportunities ahead 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Study design and additional data from INTerpath-001

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

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

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

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

About intismeran autogene

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

About melanoma

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

About Merck’s research in melanoma

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

About Merck’s early-stage cancer clinical program

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

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

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

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

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

Melanoma

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

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

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

Selected Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

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

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

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

Immune-Mediated Pneumonitis

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

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

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

Immune-Mediated Colitis

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

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

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

KEYTRUDA With Axitinib

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

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

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

Hypophysitis

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

Thyroid Disorders

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

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

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

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

Immune-Mediated Nephritis With Renal Dysfunction

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

Immune-Mediated Dermatologic Adverse Reactions

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

Other Immune-Mediated Adverse Reactions

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

Infusion-Related Reactions

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

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lactation

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

Pediatric Use

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

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

Geriatric Use

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

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

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

Additional Selected Indications in the U.S. for KEYTRUDA

Non-Small Cell Lung Cancer

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

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

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

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

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

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

Malignant Pleural Mesothelioma

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

Head and Neck Squamous Cell Cancer

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

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

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

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

Classical Hodgkin Lymphoma

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

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

Primary Mediastinal Large B-Cell Lymphoma

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

Urothelial Cancer

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

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

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

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

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

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

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

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

Gastric Cancer

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

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

Esophageal Cancer

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

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

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

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

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

Hepatocellular Carcinoma

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

Biliary Tract Cancer

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

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

Endometrial Carcinoma

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

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

Cutaneous Squamous Cell Carcinoma

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

Triple-Negative Breast Cancer

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

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

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

Ovarian Cancer

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

Merck’s focus on cancer

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

About Merck

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

About Moderna

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

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

Moderna's focus on cancer

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

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

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

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

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

Moderna Forward-Looking Statements

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

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

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

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

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

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

Image source: Getty Images.

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

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

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

NYSE · As of 3:56 PM ET 10/22/26

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

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

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

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

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

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

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

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

Key dates in the Hyliion Holdings Corp. case

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

What happened?

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

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

What is the Hyliion Holdings Corp. lawsuit about?

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

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

What's the next step?

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

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

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

Image source: The Motley Fool.

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

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

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

NASDAQ · As of 3:51 PM ET 10/22/26

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

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

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

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

PLTR PE Ratio (Forward) data by YCharts

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

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

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

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

About Air Products 

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

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

SOURCE Air Products

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

Summary

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

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

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

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

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

Click for the complete disclosure

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

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

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

Price and EPS Surprise

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Photo: Shutterstock

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

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

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

Image source: Getty Images.

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

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

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

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

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

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

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

$30.87-$1.42 (-4.38%)

NYSE · As of 2:56 PM ET 10/22/26

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Contact [email protected] for any questions or corrections.

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

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

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

Price and EPS Surprise

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

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

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

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

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

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

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

7 Best Stocks for the Next 30 Days

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

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

See them now >>

A month has gone by since the last earnings report for KB Home (KBH - Free Report) . Shares have lost about 8.8% in that time frame, underperforming the S&P 500.

But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is KB Home due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important catalysts.

KB Home Q3 Earnings & Revenues Beat Estimates as BTO Mix Lifts MarginKB Home reported third-quarter fiscal 2026 earnings of $1.05 per share, beating the Zacks Consensus Estimate of 88 cents by 19.3%. Earnings declined 34.8% from $1.61 per share in the year-ago quarter.

Total revenues of $1.30 billion surpassed the consensus mark of $1.29 billion by 0.4% but declined 20% year over year. Results reflected lower deliveries and continued pricing pressure, partly offset by progress in the company’s Built to Order model. BTO homes represented 74% of deliveries, supporting sequential improvement in housing gross margin.

KB Home’s Homebuilding HighlightsHousing revenues totaled $1.29 billion, down 20% from $1.61 billion in the prior-year quarter. The decline primarily reflected a 19% decrease in homes delivered and a modest decline in the overall average selling price (ASP).

Homes delivered were 2,732 compared with 3,393 a year ago. The backlog conversion rate was 60% compared with 71% in the prior-year period, reflecting the shift toward a higher mix of Built to Order homes. The ASP was $473,000 compared with $475,700 a year ago.

Net orders decreased 12% year over year to 2,604 homes, while net order value fell 8% to $1.21 billion. Monthly net orders per community declined to 3.1 from 3.8, reflecting a more cautious homebuying environment.

The cancellation rate increased to 18% of gross orders from 17%. However, average community count rose 8% to 279, while ending community count increased 5% to 277. Management cited higher mortgage rates, weaker consumer confidence and affordability pressure as factors weighing on demand.

Ending backlog increased year over year for the first time in four years. Backlog rose 2% to 4,398 homes, while backlog value increased 3% to $2.05 billion. The higher backlog provides visibility into future deliveries as the company continues its Built to Order strategy.

KB Home Posts Sequential Margin ImprovementHomebuilding operating income was $67.1 million compared with $131.2 million a year ago. The corresponding margin contracted to 5.2% from 8.1%. Excluding inventory-related charges, the operating margin was 5.4% compared with 8.8%.

Housing gross margin was 16.5%, down from 18.2% a year earlier. Excluding inventory-related charges, adjusted housing gross margin was 16.8% versus 18.9%. The adjusted margin improved from 15.7% in the second quarter, helped by the stronger BTO delivery mix. SG&A expenses represented 11.3% of housing revenues versus 10% a year ago.

KBH Maintains a Solid Liquidity PositionKBH ended the quarter with total liquidity of $942.4 million, comprising $159 million of cash and $783.4 million of available capacity under its unsecured revolving credit facility. Inventories increased 5% from Nov. 30, 2025, to $5.98 billion.

Land and land development investments totaled $722.3 million in the quarter, up 40% year over year. KBH repurchased 0.9 million shares for $50 million during the quarter. The debt-to-capital was 35.7%, while book value per share increased 4% year over year to $62.56.

KB Home Moderates Q4 ExpectationsFor the fourth quarter of fiscal 2026, KB Home expects deliveries of 3,000-3,500 homes and housing revenues of $1.45-$1.65 billion. Housing gross margin is projected between 16% and 16.6%, assuming no inventory-related charges, while the SG&A ratio is expected to be between 10.3% and 10.9%. The effective tax rate is anticipated to be approximately 26%, with ending community count projected at 270-275.

For fiscal 2026, KB Home continues to expect deliveries of 10,500-11,000 homes, unchanged from its prior outlook. However, the company narrowed its housing revenue guidance to $4.90-$5.10 billion from $4.90-$5.30 billion previously. KBH now expects a housing gross margin of 16-16.2%, assuming no inventory-related charges, compared with its previous projection of 16.1-16.5%. The SG&A expense ratio is now expected at 11.5-11.7%, versus 11.4-11.8% previously.

How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in fresh estimates.

The consensus estimate has shifted -15.74% due to these changes.

VGM ScoresCurrently, KB Home has a poor Growth Score of F, a score with the same score on the momentum front. However, the stock was allocated a grade of B on the value side, putting it in the second quintile for value investors.

Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in.

OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, KB Home has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.

Lost Money on D-Wave Quantum, Inc. Stock? Glancy Prongay Wolke & Rotter LLP Investigates Possible Securities Fraud After 9.51% Share Price Drop
Investors who lost money on D-Wave Quantum, Inc. ("D-Wave" or the "Company") stock may have claims to recover their losses. Glancy Prongay Wolke & Rotter LLP ("Glancy") today announced a securities fraud investigation on behalf of D-Wave Quantum, Inc. (NASDAQ: QBTS) investors into whether the Company may have violated the federal securities laws. The investigation follows the August 25, 2026 disclosure regarding D-Wave Quantum, Inc.

Investors who lost money on D-Wave Quantum, Inc. securities can submit their D-Wave Quantum, Inc. loss information to learn about potentially pursuing claims to recover their losses.

Key facts in the D-Wave Quantum, Inc. investigation

Disclosure date: August 25, 2026Stock price decline: $1.84 per share, or 9.51%Closing price after the decline: $17.51 on August 26, 2026What happened?

On August 6, 2026, D-Wave reported its second quarter of 2026 financial results. Among other things, D-Wave issues revenue of only $3.08 million, compared to $3.1 million for the same period in 2025.

On this news, D-Wave's stock price fell $1.98 per share, or 9.28%, to close at $19.41 per share on August 6, 2026, thereby injuring investors.

Then, on August 25, 2026, D-Wave issued a press release “announc[ing] that John Markovich is retiring and thus resigning from his position as Chief Financial Officer effective September 2, 2026.”

On this news, D-Waves stock price fell $1.84 per share, or 9.51%, to close at $17.51 per share on August 26, 2026, thereby further injuring investors

"D-Wave Quantum, Inc. stock fell 9.51% following the August 25, 2026 disclosure that D-Wave reported second-quarter 2026 revenue of only $3.08 million, compared to $3.1 million for the same period in 2025. Investors who lost money deserve to know whether they were given the full picture, and our investigation will examine that question," said Charles H. Linehan, Partner at Glancy Prongay Wolke & Rotter LLP.

What's the next step?

Glancy is investigating potential claims on behalf of D-Wave Quantum, Inc. investors. Investors who lost money can contact Glancy about the D-Wave Quantum, Inc. investigation, email [email protected], or call 310-201-9150 (toll-free: 888-773-9224).

Frequently Asked Questions

Who is eligible? Investors who bought D-Wave Quantum, Inc. securities and lost money may have claims, and can contact Glancy to learn whether they are affected by the D-Wave Quantum, Inc. investigation.

What is a securities fraud investigation? In the D-Wave Quantum, Inc. investigation, Glancy is reviewing whether the Company or its executives may have made false or misleading statements to investors in violation of the federal securities laws.

Has a lawsuit been filed? This release announces Glancy's investigation, not a lawsuit. If a securities class action is later filed against D-Wave Quantum, Inc., investors may have the opportunity to seek appointment as lead plaintiff.

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

Why work with Glancy on the D-Wave Quantum, Inc. investigation? Glancy Prongay Wolke & Rotter LLP is a premier law firm with decades of experience representing investors and consumers in securities litigation and other complex class action litigation. Contact Glancy about the D-Wave Quantum, Inc. investigation. Prior results do not guarantee a similar outcome.

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Since going public in June, Space Exploration Technologies' (SPCX -7.54%) stock has been volatile.

Investors are grappling with the company's $2 trillion valuation and its ambitious agenda, ranging from providing most of the planet's wireless internet one day to launching data centers into space to building a massive Terafab facility.

There are lots of unknowns, but here's what an $8,000 investment in SpaceX could be worth in 2030.

Image source: The Motley Fool.

Analysts see massive growth ahead Stocks are typically valued on multiples of their earnings, revenue, and earnings before interest, taxes, depreciation, and amortization (EBITDA). Companies growing these metrics faster will earn higher multiples. Part of the reason SpaceX has received a $2 trillion valuation is that investors believe the company will grow quickly, and to some extent it already has.

For instance, Wall Street analysts project revenue to more than double to over $45.6 billion by year-end, while adjusted EBITDA is expected to also more than double to over $23 billion, according to S&P Global Market Intelligence.

Assuming that happens, SpaceX's current market cap values the company at 44 times 2026 forward revenue and 87 times forward EBITDA. If we look at analyst estimates in 2030, revenue is projected to absolutely soar to over $492.5 billion, while adjusted EBITDA would surge to over $357 billion.

The 2030 revenue projection is the average among 20 analysts, with a pretty large disparity in estimates. The low estimate is roughly $219 billion, while the high estimate is over $708 billion.

There are also 20 estimates for adjusted EBITDA, ranging from roughly $99 billion to $576.5 billion. If you were to apply the same multiples SpaceX trades at today to these forward estimates, the company would be valued at $21.6 trillion based on revenue and nearly $31 trillion based on adjusted EBITDA.

Typically, as companies get much bigger and their markets become more saturated, their multiples decline. However, if SpaceX grows like this, where revenue and adjusted EBITDA are growing by 10- and 15-fold, who knows what the stock's multiples would be?

If we assume multiples get cut in half, the stock would be valued anywhere from $10.8 trillion on revenue to $15.5 trillion on adjusted EBITDA. If we go with this more conservative approach right now, an $8,000 investment in SpaceX would be worth between $43,200 and $62,000, generating spectacular returns.

A valuation exercise is largely theoretical Assigning a multiple to a stock is done on an imperfect basis, and it's even more difficult when we are largely in uncharted territory. SpaceX is an ultra-fast-growing stock already garnering a multitrillion-dollar valuation. The market is naturally going to be skeptical.

But what's even more important is examining the underlying assumptions that drive revenue and EBITDA to see whether they make sense.

We don't know exactly what's behind each analyst's assumptions, but if they are giving SpaceX credit for launching data centers into space or completing activities with SpaceX's super-heavy-lift, fully reusable rocket, Starship, there is a lot that could go wrong.

Starship is still in testing, and things like data centers in space are still by no means a guarantee, as are many of SpaceX's ambitions. Just looking at this year alone, analysts think revenue will jump from $7.8 billion in the second quarter to over $20 billion by the fourth quarter.

Also, after each quarter, analyst projections can change significantly as they incorporate new information into their models.

Additionally, for SpaceX to achieve everything it wants to, it will incur significant capital expenditures, likely requiring the company to take on substantial debt and issue equity, which would dilute existing shareholders.

On average, analysts project that SpaceX will have close to $1 trillion in capex, including the full years of 2026 through 2030, and generate tens of billions of dollars in negative adjusted free cash flow.

It's hard to know where all this funding might come from, or whether it's even possible.

The risk factor In theory, an investment in SpaceX could generate phenomenal shareholder gains. But it depends on many assumptions that may not materialize and on goals that may not be met, so I still view the stock as a very risky investment right now.

Greg Abel became the CEO of Berkshire Hathaway (BRKA +1.50%) (BRKB +1.88%) at the beginning of the year after the company's longtime leader, Warren Buffett, stepped down. Some investors may worry that Abel will make significant changes to the business.

But so far, the evidence suggests otherwise. Besides closing some positions formerly managed by Todd Combs, an investment lieutenant of Buffett's who also left the company recently, Abel hasn't made that many major changes.

He has also explicitly said that he intends to maintain the company culture intact, while keeping major stock holdings accumulated during the Buffett era. One company Abel thinks could compound over the long run is Apple (AAPL +0.71%), which became Berkshire's top holding years ago during Buffett's tenure and remains so.

Apple accounts for about 22% of the conglomerate's public equity portfolio, and it recently reached a major milestone, closing above a $5 trillion market cap for the first time, and only becoming the second company to do so. With all that said, should retail investors also be bullish on Apple's long-term prospects?

Warren Buffett. Image source: The Motley Fool.

The road to $5 trillionThings haven't been easy for Apple over the past few years. The company has faced steep tariffs and legal headwinds, among other challenges. Apple has performed fairly well despite all that. How did the company manage that?

The iPhone 17, launched in 2025, has been an important growth driver over the past 12 months. This newest iPhone features various artificial intelligence (AI) capabilities. It has driven a solid renewal cycle, helping Apple generate some of its strongest quarters in years in terms of sales growth.

During the third quarter of its fiscal year 2026, which ended on June 27, Apple's revenue grew 16% year over year to $109.4 billion. Apple's revenue growth has been in double digits for several quarters in a row now, after spending years below that.

AAPL Revenue (Quarterly YoY Growth) data by YCharts

Meanwhile, the company's earnings per share (EPS) of $2.02 was up 29% year over year. A $0.11 tariff refund positively impacted Apple's EPS, but even without that, it would have grown by almost 22% year over year, a solid performance for a company of this size. Apple's iPhone segment did much of the heavy lifting.

It recorded sales of $54.3 billion, up 21.6% compared to the year-ago period. In fact, Apple has been struggling to keep up with iPhone demand, with the company's former CEO, Tim Cook -- who stepped down at the end of August -- saying demand has exceeded management's expectations.

Supply-constraint problems aside, this highlights that Apple's iPhone remains highly popular and can still drive strong revenue growth. It has been Apple's most important asset on its road to reaching the $5 trillion mark.

AAPL Apple$346.45+$2.46 (+0.71%)

NASDAQ · As of 1:35 PM ET 10/22/26

What's next for Apple?Apple's newest iPhone lineup includes the 18 and the company's first attempt at a foldable smartphone, the iPhone Duo. The company also continues to pursue the same AI strategy. It seeks to integrate the technology into its hardware to enhance capabilities in ways that will help attract new users and drive strong renewal cycles among existing ones.

Apple showed this strategy can be successful with the iPhone 17, and the company might only be getting started. The iPhone Duo looks particularly promising, since foldable devices launched by some of the company's competitors have been a hit. So, expect Apple to continue expanding its installed base, which has surpassed 2.5 billion active devices.

Apple's vast ecosystem will also continue to be a source of high-margin, recurring revenue, thanks to the company's subscriptions. Further, Apple generates significant free cash flow, which can allow the company to tap into new opportunities and quickly ramp them up thanks to its vast ecosystem.

It has done so in the past. Devices such as AirPods and Apple Watches quickly grew in popularity, especially because they can connect to Apple's existing devices in ways products outside the company's ecosystem can't. That's another way in which Apple's ecosystem is a strength.

True, the company's challenges have not disappeared, but it has also proven it can navigate them. So, Apple's long-term prospects remain highly attractive. No wonder Abel and Buffett are both bullish on the stock.

The Tradr 2X Short META Daily ETF (BATS:METQ) is drawing attention among the day’s top-performing ETFs as Meta Platforms Inc. (NASDAQ:META) shares face pressure following the social media giant’s latest earnings report and fresh legal troubles.

• Meta Platforms stock is taking a hit today. Why is META stock falling?

Meta shares fell more than 6% on Thursday after investors weighed stronger-than-expected revenue against rising artificial intelligence spending, a multibillion-dollar legal charge and a new $25 billion penalty in a data-privacy case. The stock had initially gained following the company’s third-quarter results. Reuters reported that the market was reassessing the cost of Meta’s AI ambitions despite progress in its business.

Why Meta Stock Is Under PressureMeta reported third-quarter revenue of $64.60 billion, up 26% year over year and ahead of analysts’ expectations. It also forecast fourth-quarter revenue of $73 billion to $76 billion, above the consensus estimate of $73.57 billion.

However, profitability and cash generation presented a more complicated picture.

The company recorded a $9.89 billion legal charge tied to its settlement with 52 state attorneys general over teen mental health litigation. Operating income fell 37% to $12.99 billion, while free cash flow turned negative at $2.12 billion.

Meta also raised its full-year capital expenditure outlook to $135 billion to $145 billion as it continues investing aggressively in AI infrastructure. Investors must weigh whether future AI-driven advertising growth and new products will generate sufficient returns to justify the spending.

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Adding to the legal overhang, a New Mexico judge ordered Meta to pay $25 billion in a separate data-privacy case linked to allegations that the company misled users about its privacy practices.

How METQ Benefits From a Meta Sell-OffMETQ is designed to deliver 200% of the inverse of Meta stock’s daily performance, before fees and expenses. In practical terms, if META falls 1% over a trading day, METQ targets a gain of approximately 2%. If META rises 1%, the fund targets a loss of approximately 2%.

That makes the ETF a potential instrument for traders seeking short-term bearish exposure to Meta without directly shorting its shares. The fund resets its exposure daily, meaning its returns over multiple sessions can differ substantially from twice the inverse of META’s cumulative return.

For example, a 5% decline in META would imply a roughly 10% gain for METQ over that same day, assuming the fund meets its daily objective. Actual returns can differ because of expenses, market movements and tracking effects.

Price AnalysisMETQ ETF shares were up 13.72% at $16.98 at the time of publication on Thursday, according to Benzinga Pro data. This notable increase indicates a strong bullish sentiment among traders, likely driven by recent volatility in the underlying Meta stock, which has been subject to significant market fluctuations.

The current price is positioned 6% below the key technical levels, suggesting that there is potential resistance around the $18 mark. This level has historically served as a psychological barrier, and breaking above it could signal a shift in momentum for METQ.

Trading volume on Thursday reached 1 million shares, reflecting heightened interest and activity in the ETF.

What Traders Should Watch NextThe immediate question is whether Meta’s post-earnings weakness persists or whether investors refocus on accelerating advertising revenue and the company’s AI initiatives, including its Muse products.

METQ’s performance will depend primarily on Meta’s daily share-price moves, rather than on whether the company’s long-term business outlook is improving or deteriorating. A rebound in Meta shares could quickly reverse gains in the inverse ETF.

The fund is therefore best understood as a high-risk, short-term trading vehicle rather than a straightforward way to express a long-term view on Meta. Its daily leverage can amplify losses as well as gains, and volatility can erode returns over longer holding periods.

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Key Takeaways Uber's $2.3B ezCater acquisition aims to expand Uber Eats into workplace catering & large-order delivery.Uber is expanding its robotaxi footprint through partnerships with Wayve, WeRide & Zoox in key markets.Uber's valuation and expansion efforts aid its outlook, but debt & weak stock performance weigh.
Although Uber Technologies’ (UBER - Free Report) core business is ride-hailing, it has steadily expanded into areas like food delivery and freight. Diversification is crucial for large companies to manage risk, and Uber has been particularly effective in doing so through acquisitions, geographic expansion, new product offerings and innovation.

Uber’s efforts to grow internationally are noteworthy, as they provide the added advantage of geographic diversification. Through strategic investments, Uber continues to broaden services and strengthen its platform. Given this expansion-oriented backdrop, the question that naturally arises is whether investors should buy UBER stock at current prices. Let us dig deeper to find out.

A Sneak Peek Into Uber’s Recent Expansion MovesEarlier this month, Uber agreed to acquire ezCater, a major U.S. catering and workplace-meals platform, in an all-cash transaction valued at $2.3 billion. These acquisition is aimed at expanding Uber Eats into the large-order catering market while strengthening Uber for Business. The transaction is expected to close in the coming months, subject to regulatory approvals and customary closing conditions.

The combination will bring together ezCater’s catering and business-to-business expertise, Uber Eats’ broad consumer and restaurant network, and Uber for Business’s corporate relationships. The expanded platform is expected to provide restaurants with access to more high-value orders and new customers, while making it easier for businesses and consumers to arrange meals for workplaces, meetings, events and other group occasions.

The transaction may also create additional earning opportunities for Uber Eats couriers by increasing the volume of larger catering deliveries. Uber expects the business to be margin accretive. The acquisition could meaningfully strengthen Uber’s competitive position against DoorDash (DASH - Free Report) in the U.S. food-delivery market by giving it a stronger foothold in workplace catering and large group orders, a segment the latter is also actively targeting. DASH for Business launched expanded workplace catering offerings in April 2026, including tray-style catering and team-meal solutions, after large team orders grew 30% faster than regular orders.

DoorDash and Uber Eats are the two largest food and grocery delivery platforms. Earlier this month, Uberannounced a partnership with Sur La Table, a specialty kitchenware retailer, to offer customers convenient access to premium cookware, kitchen appliances and culinary essentials through the Uber Eats marketplace. The collaboration will extend across all Sur La Table locations nationwide, enabling customers to place orders for on-demand or scheduled delivery.

Through this partnership, Uber Eats customers can purchase a wide selection of kitchen products, ranging from cookware and baking equipment to everyday utensils and hosting essentials. The assortment includes products from established brands such as Le Creuset and All-Clad. Eligible orders can be delivered in as little as 25 minutes, providing a convenient option for customers seeking last-minute cooking supplies, kitchen appliances or gifts.

Uber's Partnership-Driven AV Expansion Looks GoodUber is seeking to establish a strong position in the robotaxi market through strategic collaborations. This partnership-led approach allows the company to avoid the substantial research and development expenses involved in building autonomous-driving technology in-house. Uber divested its self-driving division in 2020. The company remains committed to strengthening its position as a leading ride-hailing super app.

Consistent with this strategy, Uber has recently secured several partnerships to expand its autonomous mobility footprint. Last month, Uber and British AI company Wayve launched supervised autonomous rides in London, marking the first availability of such services in the United Kingdom. Moreover, Uber, WeRide (WRD - Free Report) and AVOMO secured Spain's first national permit for Level 4 autonomous passenger vehicles. The Madrid rollout will start with 20 WeRide-equipped vehicles, with commercial service targeted by the end of 2026. The approval represents WeRide’s ninth autonomous-driving permit globally and strengthens Madrid’s role as a gateway for its broader European expansion. Madrid is one of Europe’s largest urban mobility markets.

Earlier this year, Uber also formed a strategic alliance with Amazon (AMZN - Free Report) subsidiary Zoox to introduce the purpose-built robotaxis on its platform. Unlike many autonomous vehicles being developed by modifying conventional passenger cars, Zoox's robotaxis are designed specifically for ride-hailing operations, with an emphasis on passenger comfort and social interaction. Uber and Zoox expect to make these autonomous rides available in Los Angeles next year.

Uber's established leadership in the ride-hailing market provides an additional competitive advantage in autonomous mobility. Its extensive customer and driver network positions the company to rapidly scale robotaxi services as autonomous-driving technology advances. Moreover, Uber's platform is designed to accommodate autonomous vehicles from multiple partners, offering riders greater flexibility and a wider range of transportation choices.

Uber’s Key MetricsDespite Uber’s recent expansion-oriented moves, shares have declined in high single digits (% -wise) over the past six months, underperforming the Zacks Internet-Services industry over the same time frame.

6-Month Price ComparisonImage Source: Zacks Investment Research

From a valuation standpoint, UBER trades at a 12-month forward price-to-sales of 2.12X. UBER is inexpensive compared with its industry.

Image Source: Zacks Investment Research

See how the Zacks Consensus Estimate for Uber’s earnings has been revised over the past 90 days.

Image Source: Zacks Investment Research

How to Play UBER Stock Currently?While Uber’s weak stock performance, high debt load, labor unrest and geopolitical woes present near-term challenges, the long-term outlook for the ride-hailing giant remains far from discouraging.

The company’s strategic diversification, AV focus and shareholder-focused initiatives continue to serve as key strengths. With a market capitalization of $138.12 billion, Uber remains well positioned to navigate economic uncertainties. Uber’s ongoing commitment to diversification — through acquisitions, geographic expansion and innovative product offerings — has helped reduce risks and reinforce its competitive standing.

Overall, Uber’s scale, strategic investments and diversification efforts provide a strong foundation for sustained long-term growth. Despite the recent unfavorable price performance, maintaining a position in this Zacks Rank #3 (Hold) stock appears to be a sensible approach for now, while potential investors may prefer to wait for a more attractive entry point.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.   

Amazon's cloud business is accelerating at its fastest pace in 18 quarters, but the company just burned through billions in free cash flow. Whether that spending fuels massive gains or derails a monthly investment plan depends on a few key…

If you put $1,000 a month into Amazon (NASDAQ:AMZN | AMZN Price Prediction) starting with today’s price of $250, you would contribute $60,000 over five years.

Amazon deserves a forward look because its cloud business is speeding up again. AWS revenue grew 37% YoY last quarter, its fastest in 18 quarters, as demand for AI infrastructure rose.

What $1,000 a Month Could Grow to by 2031
Under the base case, $1,000 a month could be worth about $91,715.41 by 2031, a total return of 52.9% on the $60,000 you put in. It amounts to a gain of about $31,715.

The estimate assumes a five-year base-case target of $547.86 per share by October 17, 2031. For a share bought today, that would mean making 119.15%, or 16.99% a year.

The monthly plan returns less than a single share bought today because each later deposit has less time to grow. Your final contributions are invested for only a month or two. The dollar figures assume you invest at the start of each month and that the stock grows steadily at each scenario’s annualized rate.

Bull, Base and Bear Results for Your Monthly Plan

Scenario
5-Year Target Price
Share Total Return
Annualized Return
Value of $1,000/Month
Return on $60,000 Invested

Bull
$651.48
160.59%
21.11%
$101,398.77
69%

Base
$547.86
119.15%
16.99%
$91,715.41
52.9%

Bear
$360.38
44.15%
7.59%
$72,664.57
21.1%

Its confidence score is 0.7, which it rates as high. Wall Street is lopsided too. There are 16 Strong Buy ratings, 43 buy ratings, 2 hold ratings and 0 sell ratings.

The consensus price target is $331.46. Over a shorter window, the model’s one-year base target of $329.06 means 31.62% upside.

Three Growth Engines Behind the Target
AWS Is Accelerating on AI Demand
AWS now runs at a $169 billion annualized revenue rate, and its backlog has reached $496 billion. Amazon’s AI business and its chip business each exceeded a $25B annualized run rate with triple-digit growth (the power, cooling, and networking suppliers feeding that expansion are the subject of a free report on seven AI infrastructure names that aren’t chipmakers).

CEO Andy Jassy said on the earnings call that AWS could “very possibly be a trillion dollar annual revenue business for us in time.”

Advertising Keeps Compounding
Ad revenue rose 26% year-over-year to $19.8 billion. Ad slots for Thursday Night Football, the NBA and NASCAR “all sold out.” Advertising has high margins, so this growth adds to profits without needing the heavy spending that AWS requires.

Earnings Estimates Are Moving Higher
The average analyst estimate for 2026 EPS is $12.8977, up from $8.6938 90 days ago. Over the past 30 days, analysts made 4 up revisions and 0 down ones.

A one-time gain ballooned that 2026 number. Q2 GAAP EPS of $5.75 included a $53.4B pre-tax gain tied to Amazon’s Anthropic investment. That helps explain why the 2027 estimate is lower, at $10.5435.

Risks That Could Shrink Your Ending Balance
Spending is the biggest risk. Amazon plans about $200B of capital spending in 2026, and trailing 12-month free cash flow turned negative at -$7.6B. Jassy said the company will “encounter free cash flow headwinds until these data centers come online to be monetized.” If AI demand cools before that capacity pays off, the upside thesis falls apart quickly.

Management also pointed to tariffs, currency swings, memory chip supply and recession risk. Valuation matters as well: the stock trades at a P/E of 35 with a beta of 1.456, so it tends to swing more than the market.

Shares fell 4.74% in the past week alone. Over the last five years they making 46.67%, well below the projected pace. Even the bear case assumes a gain, and a real downturn could leave your plan below the $60,000 you put in.

Monthly investing does help with swings like these. When the price falls, each $1,000 buys more shares.

Where Your $60,000 Could Land
In all three scenarios, $1,000 a month in Amazon ends somewhere between $72,664.57 and $101,398.77 by 2031, with the base case at $91,715.41.

Watch AWS growth and free cash flow in each earnings report. Those two numbers will show which scenario is playing out. It is a projection, not investment advice, and no outcome is guaranteed.

Contact [email protected] for any questions or corrections.

Nvidia NVDA shares fell more than 4% on Thursday as chip stocks came under renewed pressure, with investors growing increasingly concerned about the financing required to sustain the artificial intelligence boom.

The selloff extended across the technology sector, with the Nasdaq Composite down 2.5%, the S&P 500 falling 1.4% and the Dow Jones Industrial Average losing around 0.2% at around 1:10 PM EST.

The Philadelphia Semiconductor Index tumbled over 6%, reflecting mounting unease over the costs, capacity constraints and potential returns associated with AI investments.

The weakness came as a sharp rise in oil prices added another source of uncertainty. Brent crude climbed nearly 3% to above $112 a barrel, while West Texas Intermediate advanced around 2% to more than $99.

Fresh Houthi attacks in Saudi Arabia and uncertainty surrounding the possibility of renewed US and Israeli strikes against Iran heightened concerns about energy supplies and inflation, further putting equity markets under pressure.

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A sharp selloff makes NVDA a compelling momentum buy for AI chip demand.

51% of retail investor accounts lose money when trading CFDs with this provider.

Despite the recent weakness, Nvidia CEO Jensen Huang struck an optimistic tone on demand for neocloud providers, which supply cloud infrastructure to AI companies.

He argued that the industry's challenge is increasingly about securing the financing needed to expand capacity rather than finding customers.

“If you look at the fundamentals, the demand for the neoclouds is off the charts,” Nvidia CEO Jensen Huang told CNBC, referring to companies such as Coreweave and Nscale, which offer cloud-based storage to AI companies.

“What is missing in the middle is the working capital to fuel that growth… because there’s just so much demand across so many sectors of AI, there’s a scarcity of capital."

“The demand for capital is much greater than the availability of capital. That’s going to get solved.”

Huang's comments come as investors scrutinise the substantial funding required to expand AI computing infrastructure.

While demand for chips and cloud capacity remains strong, markets are increasingly focused on whether companies can finance their expansion without taking on excessive risks or relying on circular investment arrangements.

Questions about interconnected investments across the AI supply chain have added to the nervousness. According to Korean media, Nvidia and Tesla are investing a combined 3.7 trillion won, or approximately $2.8 billion, in Samsung Electro-Mechanics to establish dedicated production facilities for advanced flip-chip ball grid array (FC-BGA) semiconductor substrates used in AI chips and data-center networks.

The arrangements have revived concerns about circular financing, in which companies provide funding to customers or partners that subsequently spend the money on their products.

Investors fear such practices could inflate apparent demand, encourage excess manufacturing capacity and weaken the underlying economics of the AI investment cycle.

Lam Research's latest results offered evidence of continued demand, but also highlighted limits on how quickly the supply chain can respond.

The semiconductor equipment maker reported record quarterly revenue of $8.22 billion and adjusted earnings of $2.20 per share, beating expectations.

However, CFO Doug Bettinger said its quarterly revenue guidance figure of $8.6 billion "would have been a bit higher if not for some near-term supply chain constraints."

For Nvidia, the broader market reaction underlines the tension facing the AI industry: demand for computing capacity remains substantial, but financing costs, supply bottlenecks and questions about investment returns are becoming harder for investors to ignore.

Key Takeaways AT&T shares dropped 13.4% in four weeks despite 20.4% earnings growth and an improved 2026 profit outlook.AT&T added 442,000 fiber and 379,000 postpaid phone subscribers, but promotional pricing pressured revenue.AT&T trades at 2.1X EV/sales versus its 2.3X five-year median, while net debt climbed to $149.8 billion.
AT&T Inc. (T - Free Report) shares have fallen 13.4% in the past four weeks even as third-quarter 2026 operating trends improved. The pullback raises the question of whether valuation now better compensates investors for the company’s execution risks.

Image Source: Zacks Investment Research

Fiber expansion, wireless subscriber gains and a higher earnings outlook support the case for stabilization. Elevated leverage, promotional spending and continued legacy declines keep the setup from becoming a straightforward buying call.

AT&T’s One-Month Slide Tests the Bull CaseAT&T reported third-quarter adjusted earnings of 65 cents per share, up 20.4% year over year, while revenues increased 5.3% to $32.32 billion. Both measures topped the Zacks Consensus Estimate.

Management also raised its 2026 adjusted earnings outlook to around $2.40 per share from $2.25-$2.35. The stronger operating picture contrasts with the recent share weakness, though the decline should not be tied to any single factor.

T’s Fiber Momentum Still Supports Service GrowthAT&T added 769,000 Internet connections across consumer and business accounts, including 442,000 fiber additions and 327,000 fixed wireless additions. Advanced home Internet service revenues increased 23.4% year over year.

Fiber reach rose to 39.7 million locations. AT&T remains on track to exceed 40 million locations by year-end 2026, giving the company a broader base for convergence with wireless services.

AT&T’s Wireless Gains Face Promotion PressureWireless service revenues rose 5% year over year and AT&T added 379,000 postpaid phone subscribers. Postpaid phone churn reached 0.92%, up from 0.86% in the second quarter.

Promotional discounts and introductory fiber pricing remain a trade-off. Fiber average revenue per user declined 4% year over year. T-Mobile US (TMUS - Free Report) is expanding its broadband portfolio through fiber partnerships, adding another competitive route into home Internet. Verizon Communications Inc. (VZ - Free Report) continues to pursue mobility and broadband convergence, making its network expansion another relevant benchmark for AT&T.

T’s Debt Load Limits Near-Term Financial FlexibilityNet debt climbed to $149.8 billion after the $23 billion EchoStar spectrum purchase. Net debt to adjusted EBITDA increased to 3.13X from 2.68X in the second quarter.

AT&T still targets leverage in the 2.5X range during 2029. Capital investment, dividends, repurchases and customer acquisition spending all compete for cash, making debt reduction an important part of the recovery case.

AT&T’s Valuation Leaves Room for a ReassessmentAT&T trades at 2.1X trailing 12-month enterprise value-to-sales, below its five-year median of 2.3X. The multiple also sits well below the Zacks sub-industry at 8.2X, the sector at 8.3X and the S&P 500 at 5.7X.

The valuation discount is paired with projected current-fiscal-year EPS growth of 9.9%. That combination leaves room for a reassessment if operating gains persist, but execution and deleveraging remain central to sustaining a higher valuation.

AT&T’s Mixed Signals Favor a Balanced ViewThe lower share price and discounted valuation improve the entry-point argument, but AT&T still carries enough financial and operating risk to warrant a measured stance. Fiber and wireless growth support the case, while leverage and pricing pressure limit near-term flexibility.

The stock currently carries a Zacks Rank #3 (Hold). AT&T has a Value Score of A, Momentum Score of A and VGM Score of A, but its Growth Score of C is less favorable. The mix points to attractive value and momentum characteristics without the stronger earnings-revision signal associated with a top-ranked stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Multi-chain access through Morgan Money® supports the growth of the firm's onchain platform for qualified U.S. investors

, /PRNewswire/ -- J.P. Morgan Asset Management today announced its tokenized money market funds, My OnChain Net Yield Fund ("MONY") and JPMorgan OnChain Liquidity–Token Money Market Fund ("JLTXX"), are now available on the Solana blockchain to qualified U.S. investors, strengthening the firm's capabilities. This expansion broadens access for clients and supports the continued growth of J.P. Morgan Asset Management's tokenized cash management platform.

J.P. Morgan Asset Management today announced its tokenized money market fund suite, My OnChain Net Yield Fund ("MONY") and JPMorgan OnChain Liquidity–Token Money Market Fund ("JLTXX"), is now available on the Solana blockchain to qualified U.S. investors, strengthening the firm's tokenized capabilities. This expansion broadens access for clients and supports the continued growth of J.P. Morgan Asset Management's tokenized cash management platform.

MONY is a 506(c) private placement fund that provides qualified investors the opportunity to earn U.S. dollar yields. At the time of its launch in December 2025, J.P. Morgan was the largest global systemically important bank to launch a tokenized money market fund on a public blockchain. JLTXX is a U.S. registered government money market fund designed to invest in a manner to support stablecoin issuers under the GENIUS Act.

Investors can access MONY and JLTXX through Morgan Money®, J.P. Morgan Asset Management's open-architecture trading and analytics platform for liquidity management. Through a single platform, qualified investors can subscribe and redeem into J.P. Morgan Asset Management's tokenized funds, receiving token balances at their blockchain addresses. This process supports a consistent experience as clients continue to expand tokenized activity across networks and multi-chain adoption accelerates.

"Our clients operate across more than one network, and their liquidity should too," said Paul Przybylski, Global Head of Product, Digital & Tokenized Assets, J.P. Morgan Asset Management. "Bringing JLTXX and MONY to Solana gives stablecoin issuers and institutional investors access to the same funds, across the on-chain networks where they operate. This launch builds on our position as one of the leaders in tokenized liquidity and underscores our commitment to scaling tokenized cash management through multi-chain channels."

For more information, please visit our dedicated website. The MONY blockchain token address on Solana is EToDtBM2knZ8N1BHyUq2Riq5ngWTcoD3k6qpsgf7CKYY and the JLTXX blockchain token address on Solana is J4cTuCH6frt4AnEmKfMS2k8hsUf7K94PV62sjUJno8Cz.

About J.P. Morgan Asset Management
J.P. Morgan Asset Management, with assets under management of $4.8 trillion (as of 9/30/2026), is a global leader in investment management. J.P. Morgan Asset Management's clients include institutions, retail investors and high net worth individuals in every major market throughout the world. J.P. Morgan Asset Management offers global investment management in equities, fixed income, real estate, hedge funds, private equity and liquidity. For more information, visit: www.jpmorgan.com/am.

JPMorgan Chase & Co. (NYSE: JPM) is a leading financial services firm based in the United States of America ("U.S."), with operations worldwide. JPMorganChase had $5.1 trillion in assets and $372 billion in stockholders' equity as of September 30, 2026. The Firm is a leader in investment banking, financial services for consumers and small businesses, commercial banking, financial transaction processing and asset management. Under the J.P. Morgan and Chase brands, the Firm serves millions of customers in the U.S., and many of the world's most prominent corporate, institutional and government clients globally. Information about JPMorgan Chase & Co. is available at www.jpmorganchase.com.

About Morgan Money
Morgan Money is J.P. Morgan Asset Management's institutional investing platform. A multi-currency, open architecture trading and risk management system, the platform is designed to deliver a seamless customer experience, centered on operational efficiency, end-to-end system integration, and effective controls to allow customers to invest when, where and how they want — securely. Its intuitive platform allows customers to view aggregated account information across their entire portfolio, conduct in-depth risk analysis, model potential trades and compare available investment options. This platform is designed for clients, by clients — embedding their needs and priorities into its core capabilities. Additional information is available at https://www.morganmoney.io/.

JLTXX: Contact JPMorgan Distribution Services, Inc. at 1-800-480-4111 for a prospectus. Carefully consider the fund's objectives, risks, charges and expenses of the mutual fund before investing. The prospectus contains this and other fund information. Read it carefully before investing.

MONY -- FOR QUALIFIED INVESTORS ONLY.  MONY is intended for investors who qualify to invest in private placement funds. Generally, they would include investors who are "Qualified Purchasers" as described in the Investment Company Act of 1940, as amended, and "Accredited Investors" as defined in the Securities Act of 1933, as amended.

Blockchain technology is new and evolving, and its use by the Fund carries risks, including transaction delays or errors, security breaches, regulatory changes, fluctuating fees, and network splits that create alternative blockchains. Differences from traditional mutual funds may also affect how issues are addressed. Investors should safeguard their private keys, and future regulation may affect blockchain adoption.

You could lose money by investing in the Funds. Although the Funds seek to preserve the value of your investment at $1.00 per share, they cannot guarantee they will do so. An investment in the Funds are not a bank account and is not insured or guaranteed by the Federal Deposit Insurance Corporation or any other government agency. The Funds' sponsor is not required to reimburse the Funds for losses, and you should not expect that the sponsor will provide financial support to the Funds at any time, including during periods of market stress.

JLTXX is distributed by JPMorgan Distribution Services, Inc. The U.S. placement agent for MONY is J.P. Morgan Institutional Investments, Inc.; both entities are members of FINRA. 

SOURCE J.P. Morgan Asset Management

Key Takeaways Royal Caribbean is set to report Q3 earnings on Oct. 27, with EPS expected to rise 11% to $6.38.Strong cruise demand, record pricing and onboard spending are likely to boost Royal Caribbean's Q3 revenues.Royal Caribbean faces a 200-basis-point yield headwind in Q3, while cruise operating costs may rise 10.4%.
Royal Caribbean Cruises Ltd. (RCL - Free Report) is scheduled to report third-quarter 2026 results on Oct. 27, before the opening bell.

RCL’s earnings beat the Zacks Consensus Estimate in three of the trailing four quarters, and missed on one occasion with an average surprise of 4.9%.

Trend in the Estimate Revision of RCLThe Zacks Consensus Estimate for third-quarter earnings per share (EPS) is pegged at $6.38, indicating a rise of 11% from $5.75 reported in the year-ago quarter.

For revenues, the consensus mark is pegged at nearly $5.59 billion. The metric suggests a rise of 8.7% from the year-ago quarter’s figure.

Let’s take a look at how things have shaped up in the quarter.

Factors Likely to Shape Royal Caribbean’s Q3 ResultsTop Line: Royal Caribbean’s third-quarter revenues are likely to have benefited from robust demand for cruise vacations, increased capacity and sustained consumer spending on premium travel experiences. Strong booking volumes, record pricing and continued momentum in onboard spending and pre-cruise purchases are expected to have supported revenues. The company's differentiated fleet, private destinations and expanding loyalty programs likely contributed to guest engagement and spending.

Our model estimates third-quarter passenger ticket revenues to rise 5.8% year over year to $3.8 billion. We expect onboard and other revenues to rise 14.9% year over year to $1.7 billion.

However, prolonged geopolitical tensions in the Middle East are likely to have weighed on booking momentum and yield growth for select European itineraries, particularly Mediterranean sailings. Higher international air travel costs and consumers' preference for closer-to-home destinations may have further influenced booking patterns. Deployment mix, new-ship timing and dry-dock comparisons are expected to have created an approximately 200-basis-point headwind to third-quarter yields. Our model predicts third-quarter net yields at $301.7 (on a reported basis) and $300.5 (constant-currency basis).

Margins: Royal Caribbean's third-quarter profitability is likely to have benefited from disciplined cost management, operational efficiencies and continued efforts to optimize spending. The company's focus on leveraging technology and artificial intelligence to improve productivity, alongside its expanding scale, is expected to have supported earnings growth.

However, elevated fuel prices and the timing of operating expenses may have posed challenges. Certain costs that shifted from the first half into the second half of 2026 could have affected quarterly expenses. Our model projects third-quarter 2026 total cruise operating expenses to rise 10.4% year over year to $2.7 billion.

Nonetheless, fuel hedging arrangements likely provided some protection against market volatility. Royal Caribbean expects third-quarter net cruise costs per available passenger cruise day, excluding fuel, to decline 1.1%-1.6% in constant currency. The company expects third-quarter adjusted EPS to be between $6.26 and $6.36.

What Our Model Says About RCL StockOur proven model predicts an earnings beat for Royal Caribbean this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat.

Royal Caribbean’s Earnings ESP: Royal Caribbean has an Earnings ESP of +0.13%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.

RCL’s Zacks Rank: The company currently has a Zacks Rank #3.

Other Stocks Poised to Beat on EarningsHere are some other stocks from the Zacks Consumer Discretionary sector that investors may consider, as our model shows that these, too, have the right combination of elements to post an earnings beat.

Marriott Vacations Worldwide Corporation (VAC - Free Report) has an Earnings ESP of +10.02% and a Zacks Rank of 1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Marriott Vacations is expected to register a 45% increase in earnings for the to-be-reported quarter. VAC reported better-than-expected earnings in the trailing three out of four quarters and missed once, the average surprise being 1.3%.

Marriott International, Inc. (MAR - Free Report) currently has an Earnings ESP of +3.43% and a Zacks Rank of 3.

 MAR’s earnings for the to-be-reported quarter are expected to increase 15.4%. Marriott reported better-than-expected earnings in the trailing three out of four quarters and missed once, the average surprise being 2.5%.

Rush Street Interactive, Inc. (RSI - Free Report) currently has an Earnings ESP of +2.44% and a Zacks Rank of 3.

RSI’s earnings for the to-be-reported quarter are expected to increase 55.6%. Rush Street Interactive reported better-than-expected earnings in the trailing two out of four quarters, missed estimates once and reported in line once, with the average surprise being 6.3%.

Key Takeaways HLT is poised to benefit from stronger business and group travel, steady leisure demand and calendar effects.Hilton's capital-light model and growing hotel pipeline support management and franchise fee growth.Middle East conflict, hotel renovations and weaker group travel in China remain key headwinds to performance.
Hilton Worldwide Holdings Inc. (HLT - Free Report) is scheduled to report third-quarter 2026 results on Oct. 27, before the opening bell.

HLT’s earnings surpassed estimates in three of the trailing four quarters and met estimates in one, with the average surprise being 4.6%.

Trend in Estimate Revision of HLTThe Zacks Consensus Estimate for the third quarter’s adjusted EPS has declined slightly in the past 30 days to $2.34 from $2.35. The revised estimated figure indicates 10.9% growth from the year-ago reported figure of $2.11 per share.

For revenues, the consensus mark is pegged at nearly $3.39 billion. The metric implies an 8.5% rise from the year-ago quarter’s figure.

Factors Likely to Shape HLT’s Q3 ResultsHilton’s third-quarter 2026 performance is likely to have reflected improving travel demand across key segments, supported by strength in business-transient and group travel. The company expects system-wide comparable RevPAR to increase approximately 4% year over year on a currency-neutral basis. Business-transient demand, particularly from small and medium-sized businesses, is likely to have supported performance, while leisure demand is expected to have remained steady. Favorable calendar effects and World Cup-related demand are also expected to have contributed to RevPAR growth.

Group and business travel are expected to have been key drivers of hotel performance during the quarter. Hilton reported strengthening midweek business-transient demand and solid growth from small and medium-sized businesses entering the third quarter. These trends, alongside continued demand across leisure travel, are likely to have supported occupancy and pricing.

Hilton’s fee-based, capital-light model is expected to have supported revenue growth. Continued hotel openings, conversions and a record development pipeline are likely to have contributed to management and franchise fees. Our model predicts third-quarter revenues from Franchise and Licensing Fees to rise 12.1% year over year to $828.6 million. We expect revenues from Base and Other Management Fees to rise 8% year over year to $100.5 million.

In addition, Hilton’s focus on owner profitability and operating efficiency is likely to have supported its asset-light business model. Initiatives to reduce loyalty and program fees, along with efforts to use technology and AI to improve hotel-level operations, are intended to help owners manage costs and strengthen hotel profitability.

However, third-quarter performance is likely to have faced some headwinds. The ongoing conflict in the Middle East is expected to have weighed on performance, while significant renovations at hotels in Hilton’s ownership portfolio and timing-related items are also expected to have affected earnings. China’s demand environment remains challenging, with weaker group travel contributing to lower RevPAR. These factors are likely to have partly offset strength in other regions and travel segments.

From an earnings perspective, Hilton expects third-quarter 2026 net income between $502 million and $516 million. Adjusted EBITDA is expected to range from $1.035 billion to $1.055 billion, while adjusted earnings per share are projected between $2.28 and $2.34. The company’s guidance also reflects the expected impact of the Middle East conflict and significant renovations in its ownership portfolio.

Overall, Hilton’s third-quarter 2026 results are expected to reflect improving business-transient and group demand, continued growth from its fee-based model and a strong development pipeline. However, geopolitical uncertainty, hotel renovations and uneven demand across regions are likely to have moderated the quarterly performance.

What Our Model Says About HLT StockOur proven model predicts an earnings beat for Hilton this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat, which is exactly the case here.

Earnings ESP for HLT: Hilton currently has an Earnings ESP of +0.58%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.

Hilton’s Zacks Rank: The company has a Zacks Rank #3 at present.

Other Stocks Poised to Beat on EarningsHere are some other stocks from the Zacks Consumer Discretionary sector that investors may consider, as our model shows that these, too, have the right combination of elements to post an earnings beat.

Marriott Vacations Worldwide Corporation (VAC - Free Report) has an Earnings ESP of +10.02% and a Zacks Rank of 1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Marriott Vacations is expected to register a 45% increase in earnings for the to-be-reported quarter. VAC reported better-than-expected earnings in the trailing three out of four quarters and missed once, the average surprise being 1.3%.

Marriott International, Inc. (MAR - Free Report) currently has an Earnings ESP of +3.43% and a Zacks Rank of 3.

MAR’s earnings for the to-be-reported quarter are expected to increase 15.4%. Marriott reported better-than-expected earnings in the trailing three out of four quarters and missed once, the average surprise being 2.5%.

Rush Street Interactive, Inc. (RSI - Free Report) currently has an Earnings ESP of +2.44% and a Zacks Rank of 3.

RSI’s earnings for the to-be-reported quarter are expected to increase 55.6%. Rush Street Interactive reported better-than-expected earnings in the trailing two out of four quarters, missed estimates once and reported in line once, with the average surprise being 6.3%.

Key Takeaways Chevron is exploring a $1 billion sale of U.S. Gulf assets, including Petronius, Tubular Bells and Llano.Chevron is prioritizing Anchor and Ballymore to reach 300,000 barrels of oil equivalent per day by 2026.CVX's potential asset sales could attract global and domestic buyers, freeing up capital for growth projects.
Per Reuters, Chevron Corporation (CVX - Free Report) is exploring the potential divestment of several mature oil and gas assets in the U.S. Gulf as part of its strategy to streamline operations and prioritize high-growth opportunities. The proposed transaction could generate approximately $1 billion, according to sources familiar with the matter, although the company has not confirmed any expected proceeds.

The energy major has initiated a marketing process involving select producing properties, with the potential divestments expected to unfold over several months. Chevron emphasized that the initiative remains in its preliminary stages and that there is no certainty of completing any transactions.

The portfolio review reflects Chevron's intention to concentrate resources on newer offshore developments with stronger long-term growth potential while optimizing its existing asset base.

Chevron Identifies Mature Gulf Assets for Potential SaleChevron's proposed divestment portfolio includes Petronius, Tubular Bells and Llano, alongside working interests in several other operated and non-operated offshore fields.

Petronius, which commenced production in 2000, is operated by Chevron in partnership with Talos Energy. Tubular Bells began operations in 2014 and is now wholly owned by Chevron. The company initially held a 43% interest in the field before acquiring the remaining ownership through its takeover of Hess.

Meanwhile, Chevron inherited a 50% stake in Llano following the Hess acquisition. The Shell-operated field has been producing since 2004.

By considering the disposal of these established producing assets, Chevron aims to better align its offshore portfolio with its strategic priorities. However, the company has clarified that the marketing process does not necessarily mean the properties will ultimately be sold.

Anchor and Ballymore Drive Chevron's Gulf Growth StrategyChevron's portfolio optimization efforts coincide with its ambition to increase U.S. Gulf production to 300,000 barrels of oil equivalent per day by the end of 2026.

The company is increasingly prioritizing newer developments, including Anchor and Ballymore, as it seeks to expand production from strategically important offshore projects.

Anchor represents a significant technological milestone as Chevron's first offshore platform operating at ultra-high subsea pressure. Ballymore, which commenced production in 2025, also forms an important part of the company's regional development strategy.

Beyond these projects, Chevron continues exploring opportunities to discover additional hydrocarbon resources near its existing offshore infrastructure. The company has also maintained an active presence in federal offshore drilling-rights auctions, reflecting its commitment to developing future production opportunities.

Strong Buyer Interest Could Support Chevron's Divestment PlansFavorable market conditions could improve Chevron's prospects of securing buyers for its mature offshore properties. Continued interest in U.S. energy assets, coupled with supportive oil prices, provides a potentially attractive backdrop for the proposed transactions.

According to people familiar with the process, the assets could collectively fetch approximately $1 billion, although the final value would depend on negotiations and market conditions.

Potential buyers may include international offshore operators seeking to establish or expand their presence in the U.S. Gulf. Domestic energy companies with existing regional operations could also participate, while other major energy producers may evaluate the opportunity.

A successful divestment would enable Chevron to further rationalize its portfolio and potentially redirect capital toward developments offering greater long-term growth prospects.

What the Asset Sale Could Mean for ChevronChevron's planned portfolio reshaping underscores its focus on improving the strategic composition of its U.S. Gulf operations rather than withdrawing from the region.

By potentially monetizing older producing fields while advancing newer offshore developments, the company could strengthen its ability to concentrate investment on projects supporting future production growth.

Nevertheless, the divestment initiative remains subject to buyer interest, valuation negotiations and transaction execution. Its ultimate financial and operational impact will depend on which assets are sold and the terms achieved.

For now, Chevron's efforts highlight a broader strategy of balancing portfolio optimization with continued investment in high-potential offshore resources.

CVX’s Zacks Rank & Other Key PicksChevron is one of the largest publicly traded oil and gas companies, with operations that span almost every corner of the globe. Currently, CVX flaunts a Zacks Rank #1 (Strong Buy).

Investors interested in the energy sector may consider some other top-ranked stocks like Canadian Natural Resources Limited (CNQ - Free Report) , Crescent Energy Company (CRGY - Free Report) and Delek US Holdings, Inc. (DK - Free Report) , each sporting a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Calgary-based Canadian Natural Resources is one of the largest independent energy companies in Canada engaged in the exploration, development and production of oil and natural gas. The Zacks Consensus Estimate for CNQ’s 2026 earnings indicates 61.4% year-over-year growth.

Crescent Energy is a U.S. onshore oil and gas producer focused on three major basins: the Eagle Ford in Texas, the Permian in Texas and New Mexico, and the Uinta in Utah. The Zacks Consensus Estimate for CRGY’s 2026 earnings indicates 46.7% year-over-year growth.

Brentwood, TN-based Delek US Holdings is an independent refiner, transporter and marketer of petroleum products. The Zacks Consensus Estimate for DK’s 2026 earnings indicates 169.4% year-over-year growth.