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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/

Pharmaceutical outfit Moderna (MRNA -7.82%) recently raised its status as a prospective investment. Specifically, earlier this month, Nasdaq Inc. -- which owns and operates the Nasdaq Stock Market -- added Moderna to its Nasdaq-100 index. The index tracks the collective performance of the Nasdaq's 100 largest listings that aren't part of the financial sector.

On the surface, it doesn't mean much; it certainly doesn't alter the company's fiscal performance.

Still, it's a bullish development if only because it puts the company on more investors' radars. It also prompts fund managers overseeing exchange-traded funds (ETFs) meant to mirror the performance of the Nasdaq-100 Index (like the Invesco QQQ Trust (QQQ -2.50%)) to purchase this stock, so their underlying portfolios accurately reflect the index.

Image source: Getty Images.

And this can be significant. Invesco's ETF alone now holds on the order of $2 billion worth of Moderna stock -- more than 2% of the $94 billion company -- while about 80% of all outstanding MRNA shares are now institutionally owned. By taking a chunk of already-issued shares out of individual investors' hands and putting them under institutional control where they tend to stay put for a while, a stock becomes more difficult to own, and therefore more expensive for ordinary investors to buy.

It's still not the top reason to consider adding this name to your portfolio, though. That reason remains the potential of its cancer vaccines, and in particular, Moderna's intismeran autogene. Combined with Merck's Keytruda as a treatment for certain types of melanoma, this drug showed impressive efficacy in phase 3 trial results announced early this year ... something else more investors are now aware of.

That being said, August's FDA approval of an updated COVID-19 vaccine, as well as the recent approval of a Moderna-made flu vaccine, are also contributing factors to this year's 700% run-up for the stock, which boosted the company's market cap enough to qualify it for inclusion in the Nasdaq-100.

James Brumley has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Merck and Moderna. The Motley Fool recommends Nasdaq. The Motley Fool has a disclosure policy.

SummaryModerna has staged a dramatic rebound, becoming the best-performing S&P 500 stock YTD, driven by pipeline optimism and strong technical momentum.I maintain a "Hold" rating on MRNA due to persistent unprofitability, negative free cash flow, and a valuation highly dependent on pipeline execution.Key catalysts include upcoming Q3 earnings on November 6 and Analyst Day on November 12, with high implied volatility and significant event-driven price risk.MRNA's technicals are bullish, with support at $170–$177 and a measured move upside target near $380, but valuation remains story-driven and speculative. hapabapa/iStock Editorial via Getty Images

Moderna (MRNA) has been perhaps the most remarkable comeback story in markets over the past 12 months. The best-performing S&P 500 stock YTD, shares bottomed under $25 over the course of a few quarters last year, finally starting to revive as 2025 came

9.83K Followers

Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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

Shares of Moderna (MRNA +14.21%) jumped more than 14% on Friday, following reports of a major new cancer research initiative.

Image source: Getty Images.

A new counteroffensive against cancerThe National Institutes of Health (NIH) plans to begin a campaign to fast-track cancer treatment research in December, according to a report by The New York Times. The program hopes to replicate the success of efforts to develop Covid-19 vaccines during the early stages of the pandemic.

The public-private partnership would bring together researchers and other resources from a range of healthcare companies and nonprofits to accelerate scientific discoveries. Initial research is expected to focus on pancreatic, liver, and colorectal cancer, as well as pediatric tumors.

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Moderna is a leader in cancer vaccine researchThe initiative comes at a time when advances in artificial intelligence (AI) and mRNA technology are making it possible for doctors to design treatments tailored to each patient's immune system.

On Aug. 19, Moderna and Merck (MRK +2.26%) announced that their co-developed investigational mRNA-based therapy, intismeran, when administered in combination with Merck's Keytruda, increased the time before cancer returned or spread in patients with high-risk melanoma.

These and other encouraging clinical trial results are prompting healthcare leaders to devote more resources to cancer research. That could help to accelerate Moderna's development timelines, potentially enabling the biotech to deliver new therapies to patients -- and profits to shareholders -- faster than previously expected.

Joe Tenebruso has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Merck and Moderna. The Motley Fool has a disclosure policy.

Shares of Moderna, Inc. (NASDAQ:MRNA – Get Free Report) gapped down prior to trading on Wednesday. The stock had previously closed at $203.46, but opened at $186.55. Moderna shares last traded at $190.8560, with a volume of 6,389,386 shares.

Moderna News Summary Here are the key news stories impacting Moderna this week:

Positive Sentiment: Investor interest remains strong in Moderna’s oncology program. Positive results and expectations for detailed Phase 3 melanoma data at next month’s ESMO meeting continue to support the view that the cancer-vaccine pipeline could become a major growth driver. Is A Cancer Vaccine Coming? Positive Sentiment: Moderna appointed Juan Andres as chief operating officer, adding leadership capacity as it prepares for the potential launch and commercial scale-up of intismeran autogene and expands its oncology portfolio. Moderna Adds Chief Operating Officer Role Neutral Sentiment: Buyers stepped in after the initial selloff, indicating that some investors continue to prioritize Moderna’s cancer-vaccine opportunity over valuation concerns. The company’s respiratory-vaccine expansion and oncology results also provide potential longer-term growth as COVID-19 demand normalizes. Moderna Climbs Despite Citigroup Downgrade Negative Sentiment: Citigroup downgraded Moderna to Sell from Hold, arguing that the stock’s outsized 2026 rally has priced in unrealistic expectations for future cancer-drug sales. Citi raised its price target to $80 from $60, but the target remains substantially below the current trading level, underscoring the valuation risk. Moderna Stock Has Run Too Far, Too Fast Negative Sentiment: The downgrade highlights uncertainty over whether early oncology data can translate into commercially significant sales. After the sharp run-up, profit-taking and skepticism about execution, launch timing, and Moderna’s still-negative earnings profile are weighing on sentiment. Moderna Stock Slumps as Citi Says It’s Time to Sell Analyst Ratings Changes Several equities research analysts have recently issued reports on the company. Sanford C. Bernstein reiterated a “market perform” rating on shares of Moderna in a report on Friday, September 25th. Loop Capital set a $135.00 price objective on Moderna in a report on Wednesday, August 19th. Bradesco Corretora raised shares of Moderna to an “outperform” rating in a research report on Friday, August 28th. Singular Research raised shares of Moderna to a “hold” rating in a research report on Wednesday, September 23rd. Finally, Jefferies Financial Group reiterated a “hold” rating on shares of Moderna in a research note on Wednesday, August 19th. Seven equities research analysts have rated the stock with a Buy rating, thirteen have given a Hold rating and five have assigned a Sell rating to the company’s stock. According to MarketBeat.com, the company has an average rating of “Hold” and an average price target of $77.83.

Check Out Our Latest Stock Report on Moderna Moderna Trading Down 1.9% The company has a fifty day simple moving average of $122.75 and a two-hundred day simple moving average of $78.93. The company has a debt-to-equity ratio of 0.09, a current ratio of 2.29 and a quick ratio of 2.18. The company has a market capitalization of $75.43 billion, a P/E ratio of -23.65 and a beta of 1.09.

Moderna (NASDAQ:MRNA – Get Free Report) last announced its quarterly earnings results on Friday, July 31st. The company reported ($1.97) earnings per share for the quarter, topping analysts’ consensus estimates of ($2.03) by $0.06. The company had revenue of $145.00 million during the quarter, compared to analysts’ expectations of $102.93 million. Moderna had a negative return on equity of 28.30% and a negative net margin of 141.43%.The business’s quarterly revenue was up 2.1% compared to the same quarter last year. During the same quarter in the previous year, the firm earned ($2.13) earnings per share. On average, analysts forecast that Moderna, Inc. will post -6.09 earnings per share for the current fiscal year.

Insider Buying and Selling In other Moderna news, President Stephen Hoge sold 40,281 shares of the stock in a transaction that occurred on Tuesday, September 15th. The stock was sold at an average price of $146.07, for a total transaction of $5,883,845.67. Following the transaction, the president owned 1,562,029 shares in the company, valued at $228,165,576.03. This trade represents a 2.51% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which is available at the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Shannon Klinger sold 3,471 shares of Moderna stock in a transaction that occurred on Tuesday, September 1st. The shares were sold at an average price of $139.95, for a total transaction of $485,766.45. Following the completion of the transaction, the insider directly owned 74,129 shares in the company, valued at approximately $10,374,353.55. This represents a 4.47% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. The sale was made to cover tax withholding obligations related to the vesting of equity awards. In the last ninety days, insiders sold 118,882 shares of company stock worth $16,862,280. 10.80% of the stock is currently owned by insiders.

Institutional Inflows and Outflows A number of hedge funds and other institutional investors have recently bought and sold shares of the company. BlackRock Inc. acquired a new position in Moderna during the 2nd quarter worth $2,142,877,000. Capital World Investors acquired a new stake in shares of Moderna in the fourth quarter valued at about $378,299,000. Theleme Partners LLP acquired a new stake in shares of Moderna in the second quarter valued at about $564,272,000. Norges Bank bought a new position in shares of Moderna in the fourth quarter worth about $79,707,000. Finally, Wellington Management Group LLP increased its stake in shares of Moderna by 4.4% in the second quarter. Wellington Management Group LLP now owns 2,461,574 shares of the company’s stock worth $172,384,000 after purchasing an additional 103,977 shares during the period. 75.33% of the stock is currently owned by institutional investors and hedge funds.

Moderna Company Profile (Get Free Report)

Moderna, Inc is a biotechnology company that develops medicines and vaccines using messenger RNA (mRNA) technology. Its platform is designed to instruct cells to produce proteins that can help prevent or treat disease, supporting the company’s work across infectious diseases, immuno-oncology, rare diseases, autoimmune conditions, and cardiovascular diseases.

Moderna’s commercial products include Spikevax, an mRNA vaccine for COVID-19, and mRESVIA, an mRNA vaccine for respiratory syncytial virus (RSV) in older adults.

Further Reading Five stocks we like better than Moderna Everyone in AI Is Quietly Copying Palantir’s Playbook Advanced Micro Devices Is Spending $8.2 Billion to Learn What AI Needs Next JPMorgan Bets on Genius Sports as the Market Loses Patience Apple’s $5.7 Billion Patent Verdict Raises a Bigger Royalty Question Receive News & Ratings for Moderna Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Moderna and related companies with MarketBeat.com's FREE daily email newsletter.

Juan Andres to Return to Moderna as Chief Operating Officer

Jerh Collins to Retire Following Four Years of Leadership at Moderna

CAMBRIDGE, MA / ACCESS Newswire / September 30, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced the addition of a Chief Operating Officer role to support the increasing scale and diversification of the Company.

The new role comes as Moderna prepares for the potential launch and scale-up of intismeran autogene following positive Phase 3 results and continues to advance a broader oncology portfolio. The Company has also expanded the infectious disease franchise, which now includes five approved vaccines following the recent U.S. FDA approval of Moderna's seasonal flu vaccine and the European Commission marketing authorization of the Company's seasonal flu plus COVID combination vaccine.

Juan Andres will return to Moderna as Chief Operating Officer, effective October 5, 2026. Mr. Andres will report to Chief Executive Officer Stéphane Bancel and serve on the Company's Executive Committee. As Chief Operating Officer, Mr. Andres will work across the Company to help drive focus, prioritization and execution while leading the manufacturing organization.

Moderna also announced that Jerh Collins, Ph.D., Chief Technical Operations and Quality Officer, has decided to retire from the Company.

"I am very pleased to welcome Juan back to Moderna as our Chief Operating Officer," said Stéphane Bancel, Chief Executive Officer of Moderna. "As we enter the next chapter of Moderna, Juan's experience leading complex global operations will be invaluable. He knows Moderna deeply and was an extraordinary partner to me as we built and scaled the Company. I look forward to working with him again as we execute on our strategy."

Mr. Andres previously spent nearly six years at Moderna, joining the Company in 2017 and serving as Chief Technical Operations and Quality Officer from 2018 through 2022. He later served as President, Strategic Partnerships and Enterprise Expansion before retiring from Moderna in 2023. During his tenure, he led the build-out and unprecedented scale-up of Moderna's manufacturing capabilities, including the rapid expansion of the Company's global manufacturing network to support the production and supply of Moderna's COVID-19 vaccine.

"I am excited to return to Moderna at such an important moment for the Company," said Mr. Andres. "Moderna has always been a special place to me, and the opportunity ahead is tremendous. I look forward to working with Stéphane and colleagues across the Company to execute on our priorities and deliver more mRNA medicines to patients around the world."

"I am also deeply grateful to Jerh for his leadership, partnership and commitment to Moderna over the past four years," said Mr. Bancel. "He has made significant contributions to our Company and built a very strong team that will carry forward the important work of manufacturing and technical operations. I wish Jerh and his family all the best in his retirement."

"It has been a privilege to be part of Moderna and to lead our Technical Operations and Quality organization," said Dr. Collins. "I am incredibly proud of what our teams have accomplished together for patients, and grateful to the many colleagues I have had the opportunity to work alongside. As I look ahead to retirement, I have great confidence in the team and in Moderna's future."

Dr. Collins joined Moderna in October 2022 and became Chief Technical Operations and Quality Officer in January 2023. During his tenure, he helped transition Moderna's manufacturing footprint for an endemic vaccine market, advanced the Company's manufacturing capabilities in the UK, Canada and Australia, and established the manufacturing model to support intismeran autogene. Prior to Moderna, he spent nearly 30 years at Novartis in roles of increasing responsibility across pharmaceutical production and manufacturing.

Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

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.

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 regarding the Company's appointment of Mr. Andres as Chief Operating Officer, the potential launch and scale-up of intismeran autogene, the advancement of Moderna's business and oncology portfolio, and the Company's strategy, priorities and plans to deliver mRNA medicines. 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 those other 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 hereof.

Moderna Contacts

Media:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
[email protected]

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

SOURCE: Moderna, Inc.

Phase 3 data for intismeran autogene in the adjuvant treatment of patients with resected stage IIB-IV melanoma selected for presentation at a Presidential Symposium

Moderna to host an investor event via webcast on Saturday, October 24, at 7:00 PM CEST / 1:00 PM EDT

CAMBRIDGE, MA / ACCESS Newswire / September 21, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that three abstracts on intismeran autogene, an investigational mRNA-based individualized neoantigen therapy, have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2026, which will be held October 23-27 in Madrid, Spain.

The presentation details are as follows:

Presidential Symposium:

LBA1- INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL)
Session Type/Title: Presidential Symposium
Date & Time: Saturday, October 24, 4:30 PM CEST / 10:30 AM EDT
Presenter: Georgina V. Long (Sydney, Australia, NSW)Poster Presentations:

Abstract 3151P: Adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma: results from a phase I study
Session Type/Title: Poster - Pancreatic cancer
Date & Time: Sunday, October 25, 12:00-12:45 PM CET
Presenter: David J. Pinato (London, United Kingdom)Abstract 2550TiP: INTerpath-014: A Phase 3 Study of Adjuvant Intismeran Autogene (Intismeran) Plus Subcutaneous Pembrolizumab (Pembro SC) or Intismeran Monotherapy vs Placebo in Completely Resected High-Risk Stage I NSCLC
Session Type/Title: Poster - NSCLC, early stage
Date & Time: Monday, October 26, 12:00-12:45 PM CET
Presenter: Charu Aggarwal (Philadelphia, United States of America)Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

Moderna Investor Event

Moderna will host a live webcast on Saturday, October 24, at 7:00 PM CEST / 1:00 PM EDT. The webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for at least 30 days following the presentation.

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 Contacts

Media:

Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
[email protected]

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

SOURCE: Moderna, Inc.

Moderna Just Doubled Overnight, and 2 More Healthcare Stocks Could Follow ItModerna NASDAQ: MRNA President Stephen Hoge said the company’s recently announced positive Phase III results for its investigational personalized cancer vaccine, intismeran, in adjuvant melanoma support a broader effort to use T-cell priming in multiple tumor types.

Speaking at a Morgan Stanley event, Hoge said the melanoma study was the first to show a statistically significant and clinically meaningful benefit over Merck’s KEYTRUDA in the adjuvant melanoma setting, according to Moderna and its partner Merck. He described the results as validation of Moderna’s decade-long scientific hypothesis that priming T cells to recognize tumor-specific mutations can generate a substantial anti-cancer response.

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MarketBeat Week in Review – 08/17 - 08/21“It’s not a checkpoint inhibitor,” Hoge said of the approach. “This is T-cell priming, not T-cell exhaustion.”

Broad Cancer Development Program Moderna and Merck have nine ongoing clinical trials involving intismeran, including multiple late-stage studies. The program includes three randomized Phase III trials in lung cancer as well as studies in melanoma, renal cell carcinoma and bladder cancer.

Moderna’s 177% Surge Has Investors Asking What Comes NextHoge said the company remains focused on reaching break-even in 2028, a target he said is based on the expected strength of Moderna’s infectious-disease vaccine business. Investments already made in intismeran and its clinical program are included in that outlook, he said.

While Moderna may consider expanding investment in the cancer vaccine program, Hoge said decisions would remain data-dependent. Potential future areas include monotherapy use and treatment in earlier-stage disease, including Stage 1 cancer.

The company expects the full melanoma data to be presented at a future medical meeting, though Hoge did not identify a specific venue. He said investors and clinicians will likely evaluate whether Phase III results resemble the earlier Phase II findings, how outcomes vary by disease stage and patient subgroups, and the timing and shape of separation in recurrence-related curves over time.

Hoge said the Phase II melanoma analyses showed favorable hazard ratios across tumor mutational burden, PD-1 status and tumor inflammation measures. However, he cautioned that it remains unclear how broadly the findings will apply across tumor types, particularly those considered less immunologically active.

Upcoming Bladder and Kidney Cancer Readouts Among nearer-term data points, Hoge highlighted fully enrolled, event-driven Phase II studies in renal cell carcinoma and muscle-invasive bladder cancer. Each trial has roughly 300 patients randomized one-to-one against standard care, with KEYTRUDA serving as the comparator in the renal cell and muscle-invasive bladder studies.

He said these studies could help determine whether intismeran can add to the benefit of PD-1 therapy beyond melanoma. Renal cell carcinoma has lower tumor mutational burden than melanoma, although Hoge noted that mutations such as frameshifts and insertions or deletions can also create antigens that the immune system may recognize.

Moderna is also conducting a Phase II trial in non-muscle-invasive bladder cancer evaluating intismeran as monotherapy. Hoge said that study could provide insight into whether the therapy can be used earlier in disease and without a checkpoint inhibitor.

On potential regulatory paths, Hoge said a melanoma approval could address many of the manufacturing, safety and chemistry-related elements needed for future applications. Whether individual Phase II studies could support registration would depend on the strength and statistical significance of their clinical evidence, he said.

Manufacturing and Retreatment Potential Hoge said Moderna has treated about 3,000 patients with intismeran, including an estimated 1,500 to 2,000 over the past 18 months, through its global clinical-trial system across more than 40 countries. The company has built a purpose-designed, automated manufacturing facility in Marlborough that is currently supplying trials.

He said the first of seven manufacturing suites at the facility should have sufficient capacity for an initial commercial launch, while additional capacity could be added with about 12 months of lead time. Hoge contrasted intismeran’s manufacturing process with CAR-T cell therapies, saying the final product uses similar chemical material across patients while the genetic sequence is individualized.

Moderna expects the long-term margin profile for intismeran to be competitive with other complex biologics rather than cell therapies, though Hoge said pricing discussions would be premature before more clinical data are available.

Hoge also said a patient whose cancer recurs could potentially receive a newly designed personalized vaccine targeting mutations in the relapsed tumor, though he emphasized that Moderna does not yet have clinical data supporting such retreatment.

Respiratory Vaccine Portfolio Expands Beyond oncology, Hoge said Moderna now has five product approvals across COVID-19, influenza, respiratory syncytial virus, a flu/COVID combination product and its next-generation COVID vaccine, mNEXSPIKE. He said the expanded portfolio improves the company’s ability to pursue portfolio-based contracting with governments, health systems and pharmacies.

Moderna’s current guidance calls for up to 10% top-line growth this year, Hoge said. He pointed to the U.S. approval of mFluSiva, Moderna’s influenza vaccine for older adults, and the European launch of its flu/COVID combination vaccine as potential contributors to the company’s commercial outlook.

Hoge said mFluSiva’s mRNA-based production process avoids egg-based manufacturing, which he said can contribute to antigenic mismatch. For the combination vaccine, he cited the potential benefit of delivering flu and COVID protection in one shot while reducing storage and administration needs for health systems.

About Moderna (NASDAQ:MRNA)Moderna, Inc is a biotechnology company that develops messenger RNA (mRNA) medicines and vaccines. Its platform is designed to provide cells with instructions to produce proteins that may help prevent or treat infectious diseases, cancer and other medical conditions.

The company's commercial products include Spikevax, an mRNA vaccine for COVID-19, and mRESVIA, an mRNA vaccine for respiratory syncytial virus (RSV) in older adults. Moderna also maintains a pipeline of investigational programs in areas such as seasonal influenza, cytomegalovirus, oncology and rare diseases.

Founded in 2010 and headquartered in Cambridge, Massachusetts, Moderna serves markets in the United States and internationally through regulatory approvals, commercial partnerships and distribution arrangements.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Key Takeaways Moderna's mFlusiva is the first mRNA-based seasonal flu vaccine approved by the FDA.GSK's mRNA flu candidate targets HA and NA, generating higher immune responses in a phase II study.Moderna has time to establish mFlusiva before GSK's candidate potentially reaches the market. Moderna (MRNA - Free Report) recently secured FDA approval for mFlusiva, the first mRNA-based seasonal flu vaccine. The decision is a significant milestone for the company, which gets an opportunity to establish a foothold in another multibillion-dollar market while further diversifying its revenue base beyond COVID-19 vaccines.

However, even before Moderna has had much time to establish its newly approved vaccine in the market, a new competitive challenge has emerged. GSK plc (GSK - Free Report) recently announced plans to advance its investigational mRNA-based flu vaccine into late-stage development later this month, following positive phase II study results.

GSK’s Move Reinforces Confidence in Moderna’s mRNA PlatformModerna has recently undergone a significant shift in investor sentiment following the positive late-stage results for its personalized mRNA cancer therapy developed with partner Merck (MRK - Free Report) . The results have helped reinforce the potential of Moderna’s mRNA technology beyond infectious diseases, particularly oncology, providing another indication that the platform could support growth across multiple therapeutic areas.

GSK’s decision to advance an mRNA-based flu vaccine into phase III development could also be viewed as another sign that large pharmaceutical companies increasingly see mRNA as a viable next-generation technology. Rather than being viewed solely as a competitive development, GSK’s investment in the technology could further strengthen confidence in the broader mRNA platform and its potential across vaccine applications.

GSK’s Vaccine Could Also Raise the Competitive Bar for ModernaGSK’s candidate is important not simply because it uses mRNA, but because it is designed to target two proteins on the surface of the flu virus — hemagglutinin (HA) and neuraminidase (NA). HA helps the virus attach to and enter cells, while NA facilitates the spread of newly formed virus particles from infected cells. By targeting both proteins, GSK is pursuing a potentially broader approach to flu prevention.

That distinction matters for Moderna because, like most existing flu vaccines, mFlusiva is based on targeting HA. GSK’s advancement of the mRNA vaccine is supported by results from a phase II study, which showed that its flu vaccine generated higher immune responses than standard-dose vaccines in younger adults and high-dose vaccines in older adults.

This could potentially position GSK’s candidate as a differentiated competitor to Moderna once it reaches the market. However, GSK’s vaccine is still at least a couple of years away from reaching the market and is subject to phase III results, where its efficacy will be tested. This gives Moderna valuable time to establish mFlusiva in the market and build awareness before GSK potentially arrives.

Meanwhile, Moderna’s mFlusiva will compete for market share against established non-mRNA-based flu vaccines marketed by GSK, Sanofi (SNY - Free Report) and CSL Seqirus, all of which have a significant presence in the seasonal influenza market.

MRNA’s Price Performance, Valuation & EstimatesShares of Moderna have skyrocketed more than 400% year to date, significantly outperforming the industry’s 10% growth.

Image Source: Zacks Investment Research

From a valuation standpoint, the company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 24.28 times forward 12-month sales, higher than the industry average of 1.94 times.

Image Source: Zacks Investment Research

Estimates for Moderna’s 2026 and 2027 loss per share have improved over the past 30 days.

Image Source: Zacks Investment Research

Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Moderna (MRNA -3.35%) shares have made an incredible comeback this year. Up by nearly sixfold over the past 12 months, the stock, formerly one of the top COVID-19 vaccine plays, has surged thanks to developments with the non-COVID aspects of its pipeline.

The most recent surge, sending the stock up around 127% in a matter of weeks, stems from a breakthrough for the biotech company. Now, the question is whether Moderna can hold on to, much less add to, these latest gains.

Image source: Getty Images.

Moderna and its cancer vaccine super rally Post-pandemic, investors bailed on what was once one of the most-followed biotech stocks amid pessimism about the company's ability to further monetize its mRNA technology. But then, as the company made further progress with its Intismeran Autogene vaccine candidate, bearishness shifted back to bullishness, turning Moderna into an incredible comeback story.

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Then, on Aug. 19, Moderna, along with pharmaceutical company Merck (MRK -0.80%), announced positive top-line results for its phase 3 INTerpath-001 trial. This trial involved giving Stage IIB-IV melanoma patients a combination of Intismeran Autogene and Merck's Keytruda.

Separating substance from hype On one hand, Moderna's super rally on the INTerpath-001 news made sense because this study strongly suggests that Moderna can succeed in employing its mRNA technology to develop effective oncology treatments. Given the massive total addressable market for such treatments, it's logical for the market to rerate shares significantly.

Then again, while the prospect of personalized cancer vaccines represents a serious game changer for medicine, keep in mind two things. First, the extent of Moderna's latest rally was likely boosted by a short squeeze. Shares initially surged by as much as 175% on the news and have since pulled back. A further cooldown in excitement could continue playing out.

Second, while by all means a likely game changer for Moderna, commercialization of these oncology MRNA products remains years away. With a nearly $60 billion market capitalization, estimated 2026 revenue of just $2.1 billion, and a stock price around $140 to $145 per share against forecast losses of $8.55 per share this year, future potential with oncology appears heavily baked in.

Even if bullish on Moderna's comeback catalyst, you may want to wait for further weakness before buying.

Moderna Stock Jumps as Wolfe Upgrade Puts Cancer Pipeline in Spotlight Summary

Moderna shares rallied as Wolfe Research upgraded the stock following encouraging late-stage results for its personalized cancer vaccine

Moderna MRNA shares climbed nearly 13% on Tuesday as investors weighed new analyst support following encouraging results from the company's late-stage cancer program.

The move came after Wolfe Research upgraded its view on the biotechnology company. BofA Securities also recently lifted its price target to $170, adding to the positive analyst momentum around the stock.

The focus is on Moderna's partnership with Merck and their Phase 3 INTerpath-001 study. The trial tested intismeran autogene, an individualized mRNA-based vaccine, together with Keytruda in patients with surgically treated high-risk melanoma.

Results released Aug. 19 showed the study achieved its main measure of recurrence-free survival. It also met a secondary goal involving the time before melanoma spread to other parts of the body.

The data could help reinforce Moderna's efforts to build a broader pipeline beyond its established vaccine business. Investors will likely look for additional clinical progress as the oncology program advances.

Positive cancer data and rising analyst support could provide another catalyst for Moderna shares, although further clinical developments remain important.

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

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Moderna stock shed 7% on Wednesday with no company news to blame, reopening a brutal question that its 439% year-to-date rally had been drowning out: what exactly does a $59 billion valuation buy on a revenue base this thin?

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Moderna stock is giving back a large chunk of Tuesday’s rally. The pullback reopens a question that a summer melt-up has largely papered over: what does a market capitalization near $59 billion actually value on this income statement?

Moderna (NASDAQ:MRNA | MRNA Price Prediction) stock is down 7% to $148.02 midday Wednesday, and no fresh company news is on the wire to explain the slide. Also lower, BioNTech SE (NASDAQ:BNTX) stock is down 2% to $111.60, a much shallower giveback that suggests the pain is Moderna-specific.

The iShares Biotechnology ETF (NASDAQ:IBB) is down 0.6% to $215.04, so the biotech cluster is barely wobbling. Meanwhile, the SPDR S&P 500 ETF Trust (NYSEARCA:SPY) is unchanged at $765.57, keeping the broad market backdrop quiet.

Profit-Taking After a Vertical Run Moderna stock closed 14% higher on Tuesday, back above $150, after Wolfe Research upgraded Moderna stock to Peer Perform from Underperform. The firm offered no new price target and pegged unadjusted peak sales at $9.2 billion across the four main indications for intismeran, the personalized cancer vaccine Moderna is developing with Merck (NYSE:MRK).

That upgrade capped a violent ascent. Moderna stock was up 439% year to date through Tuesday’s close, so a 7% giveback here reads as profit-taking after a rally that stretched the chart well beyond any near-term news catalyst.

The move has been remarkably compressed on a shorter frame as well. Moderna stock was up 194% over the trailing month through Tuesday’s close, so a 7% single-day pullback sits well within the range of recent daily swings for the name.

Modest Fundamentals for a $59 Billion Cap Moderna carries no trailing P/E ratio, because there is no trailing profit to divide into. Q2 2026 revenue was $145 million, up 2.1% year over year, and the loss of $1.97 per share matched the $1.97 consensus estimate exactly. The net loss narrowed to $782 million from $825 million a year earlier, aided by cost of sales that fell 22% to $93 million on manufacturing productivity gains.

Q1 2026 was noisier for Moderna: a loss of $3.40 per share on $389 million in revenue, with a net loss of $1.34 billion that absorbed an $878 million non-recurring litigation settlement charge. Full-year 2025 revenue was $1.94 billion, down 39%, and the company posted a net loss of $2.82 billion, or $7.26 per share.

Moderna’s management guides to up to 10% revenue growth in 2026 and year-end cash and investments of $4.7 billion to $5.2 billion. The bull case is a pipeline story where Wolfe Research alone sees $9.2 billion in peak sales from one program, and that pipeline value is legitimately hard to capture in a trailing earnings multiple. The bear case is that a $59.09 billion valuation now embeds a drug that isn’t yet approved on a revenue base of $145 million a quarter.

BioNTech Repricing With Less Drama BioNTech stock is moving far more calmly on the same session, and that gap matters. Moderna stock has repriced harder in both directions during the last week, so the read-across from Moderna stock’s session to the wider mRNA group looks weaker than it did a month ago.

The read-across works in both directions here. Moderna stock’s rally has been about proprietary pipeline optionality rather than a rising tide for mRNA platforms, which makes BioNTech SE’s muted follow-through a coherent signal on its own terms.

Merck sits in the story as the partner name on intismeran. The Moderna and Merck program is running together with KEYTRUDA across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma, which is where the $9.2 billion peak sales figure ultimately has to be earned.

What to Watch Next Given the violence of recent moves, investors sizing their exposure here may want to keep their position sizing modest and define their risk budget before adding on either dips or breakouts. Single-session swings of 7% down one day and 14% up the day before aren’t a backdrop in which full-size trades protect capital well.

Investors can watch for whether Moderna stock get capture and maintain the $150 level, which would frame the current pullback as a healthy shakeout rather than the start of a broader unwind after the year-to-date run. Moreover, traders could look for signs that the biotech cluster stays firm as Moderna decompresses, since a widening gap between the mRNA leader and its sector suggests the market is now trading pipeline outcomes over platform hype.

Contact [email protected] for any questions or corrections.

Shares of Moderna Inc. (NASDAQ:MRNA) are trading lower Monday morning, taking a breather following a multi-day surge driven by clinical trial success.

Moderna stock is trading near recent highs. What’s next for MRNA stock? Phase 3 Trial Success Validates mRNA Oncology PlatformThe major catalyst arrived last week, when Moderna and development partner Merck & Co. announced positive topline results from their Phase 3 INTerpath-001 trial. The study evaluated intismeran autogene, an experimental individualized mRNA cancer vaccine, in combination with Merck’s Keytruda for patients with high-risk Stage IIB-IV melanoma.

The trial met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival, demonstrating that the combination therapy significantly extended the time patients lived without cancer returning compared to Keytruda alone.

The successful readout represents the first positive Phase 3 trial result for a personalized mRNA cancer vaccine, providing a landmark proof-of-concept for Moderna’s platform beyond COVID-19 and respiratory treatments.

Following the Wednesday announcement, Moderna’s stock surged over 120% in a single trading session, sparking a wave of Wall Street analyst upgrades and adding tens of billions in market capitalization.

MRNA Shares Slide Monday MorningMRNA Price Action: Moderna shares were trading lower by 6.49% at $135.71 at the time of publication on Monday, according to Benzinga Pro data.

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19.8.2026 13:36, MRK, MRNA, NVAX, BNTX

Farmaceutické společnosti Moderna a Merck & Co. oznámily, že jejich personalizovaná protinádorová vakcína ve velké studii pozdní fáze pomohla snížit recidivu melanomu. Jde o první úspěšnou studii závěrečné fáze u jakékoli protinádorové terapie založené na mRNA.

Studie splnila hlavní cíl, když prokázala, že vakcína v kombinaci s imunoonkologickým lékem Keytruda od Mercku snižuje míru návratu melanomu ve srovnání se samotnou imunoterapií. Splněn byl i klíčový sekundární cíl, když vakcína pomohla bránit šíření nádorů do dalších částí těla. Konkrétní čísla k přežití bez recidivy firmy nezveřejnily, studie dále pokračuje a má posoudit, zda pacienti s vakcínou žijí déle.

Vakcína nazvaná intismeran autogene je vyvinuta pomocí technologie mRNA, která stála za covidovou vakcínou Moderny, a každá dávka se upravuje na míru podle konkrétních mutací nádoru daného pacienta. Podávána byla pacientům po chirurgickém odstranění nádoru, kontrolní skupina dostávala samotnou Keytrudu. Ve studii střední fáze měli pacienti s kombinací po pěti letech o 49 % nižší pravděpodobnost úmrtí nebo návratu rakoviny než ti na samotné Keytrudě.

Obě společnosti budou o podání žádosti o registraci jednat s regulátory a data představí na nadcházející lékařské konferenci. Generální ředitel Moderny Stéphane Bancel uvedl, že přípravek by mohl být schválen už v roce 2027 v závislosti na průběhu regulačního řízení. Merck a Moderna testují vakcínu i u dalších typů rakoviny včetně rakoviny plic, studie s melanomem jsou ale nejdále.

Vývoj akcií Akcie Moderny se obchodují na burze NASDAQ pod tickerem MRNA a v předburzovní fázi obchodování posilují o 62,42 % na 102,26 USD. Akcie Merck & Co., obchodované na NYSE pod tickerem MRK, přidávají 6,89 % na 144,48 USD.

Pozitivně reagují i další výrobci vakcín. Německý BioNTech, jehož americké depozitní certifikáty (ADR) se obchodují na NASDAQ pod tickerem BNTX a reprezentují jednu podkladovou akcii, roste o 11,05 % na 103 USD. Novavax (NVAX) posiluje o 4,04 % na 8,25 USD.

Zdroj: Bloomberg

Michal Bárta
Fio banka, a.s.
Prohlášení

mFLUSIVA becomes Moderna's fifth approved product globally and fourth FDA-approved product

Company expects supply to be available in select retailers in the coming weeks

CAMBRIDGE, MA / ACCESS Newswire / August 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older. This approval follows unanimous recommendations from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) supporting mFLUSIVA for adults 50 years of age and older.

"The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna. "Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible."

The FDA's approval of mFLUSIVA in adults 50 through 64 years of age is based on results from a randomized, observer-blind, active-controlled, Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06602024), which enrolled 40,805 adults aged 50 years and older across 11 countries. The primary objectives in this study were to evaluate the safety and reactogenicity of mFLUSIVA, and to evaluate relative vaccine efficacy (rVE) of mFLUSIVA versus a standard dose (SD) active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.

Use in adults 65 years of age and older was granted accelerated approval based on results from a randomized, observer-blind, active-controlled clinical trial (ClinicalTrials.gov Identifier: NCT05827978), which enrolled 2,992 adults 65 years of age and older in the United States. The primary objective in this study was to evaluate the immunogenicity of mFLUSIVA versus a high-dose (HD) inactivated influenza vaccine comparator. The effectiveness of mFLUSIVA in adults 65 years of age and older is also supported by the descriptive analysis of rVE in the randomized, observer-blind, active-controlled, Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06602024). Confirmation of clinical benefit in this population will be assessed in a postmarketing clinical trial.

The Phase 3 program demonstrated an acceptable safety profile for mFLUSIVA, with no new safety concerns identified, consistent with previously reported studies of mFLUSIVA.

Moderna expects to have mFLUSIVA available for eligible populations in the U.S. for the 2026-2027 respiratory virus season, alongside Spikevax® (COVID-19 Vaccine, mRNA), mRESVIA® (Respiratory Syncytial Virus Vaccine) and mNEXSPIKE® (COVID-19 Vaccine, mRNA).

mRNA-1010 has been accepted for regulatory review in the European Union, Canada and Australia. Regulatory submissions in additional countries are planned during 2026.

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.

mFLUSIVA®, mNEXSPIKE®, mRESVIA® and Spikevax® are registered trademarks of Moderna.

INDICATION

What is mFLUSIVA® (Influenza vaccine, mRNA)?

mFLUSIVA is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine. mFLUSIVA is approved for use in persons 50 years of age and older.

The indication for persons 65 years of age and older is approved under accelerated approval based on immune responses. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORTANT SAFETY INFORMATION

You should not get mFLUSIVA if you had a severe allergic reaction to any ingredient in mFLUSIVA.

Tell your healthcare provider about all of your medical conditions, including if you:

have any allergies or have had a severe allergic reaction after receiving a previous dose of any other vaccine

have had Guillain-Barré syndrome (severe muscle weakness) after getting an influenza vaccine

are immunocompromised or are on a medicine that affects your immune response

are breastfeeding, pregnant or plan to become pregnant

have ever fainted in association with an injection

What are the risks of mFLUSIVA?

Severe allergic reactions are rare but can happen after vaccination with mFLUSIVA. If a severe allergic reaction occurs, it would usually happen within minutes to one hour after a dose of mFLUSIVA. Because of this, your healthcare provider may ask you to stay for a short time after your vaccination.

Side effects that have been reported in clinical trials with mFLUSIVA include:

Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm as the injection, swelling (hardness), and redness.

General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, and fever.

These may not be all the possible side effects of mFLUSIVA. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

Please click for mFLUSIVA Full Prescribing Information and Information for Recipients and Caregivers.

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: the availability of mFLUSIVA in the U.S. for the 2026-2027 respiratory season; the results of postmarketing clinical studies for mFLUSIVA; ongoing regulatory review in the European Union, Canada and Australia; and planned regulatory submissions in additional countries. 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.

Moderna Contacts

Media:

Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
[email protected]

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

SOURCE: Moderna, Inc.

Moderna (MRNA - Free Report) came out with a quarterly loss of $1.97 per share in line with the Zacks Consensus Estimate. This compares to a loss of $2.13 per share a year ago. These figures are adjusted for non-recurring items.

A quarter ago, it was expected that this biotechnology company would post a loss of $3.02 per share when it actually produced a loss of $1.18, delivering a surprise of +60.93%.

Over the last four quarters, the company has surpassed consensus EPS estimates three times.

Moderna, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $145 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 14.49%. This compares to year-ago revenues of $142 million. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Moderna shares have added about 96.4% since the beginning of the year versus the S&P 500's gain of 8.7%.

What's Next for Moderna?While Moderna has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Moderna was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$1.28 on $942.25 million in revenues for the coming quarter and -$8.64 on $2.09 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 35% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, ANI Pharmaceuticals (ANIP - Free Report) , is yet to report results for the quarter ended June 2026. The results are expected to be released on August 7.

This drugmaker is expected to post quarterly earnings of $2.01 per share in its upcoming report, which represents a year-over-year change of +11.7%. The consensus EPS estimate for the quarter has been revised 0.3% lower over the last 30 days to the current level.

ANI Pharmaceuticals' revenues are expected to be $262.73 million, up 24.3% from the year-ago quarter.

CAMBRIDGE, MA / ACCESS Newswire / July 16, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced the dosing of the first U.S. participant in its Phase 1 study evaluating mRNA-4200, a tumor-targeted cancer antigen therapy candidate, in patients with advanced or metastatic solid tumors. mRNA-4200 encodes for seven antigens commonly shared across patients and tumor types and is designed to help induce and expand T-cell responses against selected tumor targets.

"mRNA-4200 represents our third off-the-shelf cancer antigen therapy candidate and builds on our efforts to explore broad applicability across multiple cancer types," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "By encoding multiple shared tumor targets, this investigational therapy reflects our ongoing efforts to expand the potential of cancer immunotherapy beyond single-target approaches as we continue working to transform cancer care for patients."

The first dose was administered by Dr. William McKean, Clinical Investigator at START Mountain Region in Salt Lake City, Utah, part of The START Center for Cancer Research, the world's largest community-based early-phase oncology site network.

"The first patient dosed in a study represents far more than an operational milestone--it marks the beginning of evaluating a new therapeutic approach that has the potential to impact patients with advanced cancer," said Dr. McKean. "We are proud to continue our collaboration with Moderna and to support the clinical development of mRNA-4200 by providing patients with early access to promising investigational treatments while generating the clinical evidence needed to advance cancer research."

The Phase 1 trial (ClinicalTrials.gov identifier: NCT06880549) is an open-label, multicenter, dose-escalation study that will evaluate the safety and tolerability of mRNA-4200 administered with checkpoint inhibitor therapy in adult participants with advanced solid tumors.

mRNA-4200 was developed in collaboration with Immatics under the Database Program. mRNA-4200 incorporates targets identified using Immatics' XPRESIDENT® target discovery and validation platform and its bioinformatics and AI platform XCUBE®.

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 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: the ability for mRNA-4200 to help induce and expand T-cell responses against selected tumor targets; and the potential of Moderna's mRNA platform in oncology. 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.

Moderna Contacts

Media:

Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
[email protected]

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

START Contacts

Lauren Panco
Vice President, Marketing
+1 609-216-4920
[email protected]

SOURCE: Moderna, Inc.

Moderna logo is seen displayed in this illustration taken, May 3, 2022. REUTERS/Dado Ruvic/Illustration Purchase Licensing Rights, opens new tab

CompaniesJuly 9 (Reuters) - Moderna (MRNA.O), opens new tab said on Thursday it has secured a European Commission contract to ​supply its respiratory syncytial virus vaccine ‌to six countries in the region.

Here are the details:

Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.

The agreement gives the participating countries - Austria, ​Denmark, Ireland, Luxembourg, Norway and Portugal - ​access to up to 24 million ⁠doses of the vaccine over as ​many as four years, the company said.

The ​vaccine, mRESVIA, will be supplied in a ready-to-use, single-dose pre-filled syringe, making administration easier for healthcare ​professionals, Moderna said.

The company had a ​similar joint procurement framework agreement with the European ‌Commission ⁠for COVID-19 vaccines last year.

mRESVIA is authorized in the European Union to prevent lower respiratory tract disease caused by RSV ​in adults.

RSV ​is ⁠a common respiratory virus that causes seasonal infections such as ​the flu and is a leading ​cause ⁠of pneumonia and death in infants and older adults.

Moderna has four approved mRNA vaccines for ⁠respiratory ​infections, including a combined ​influenza and COVID-19 vaccine authorized in Europe.

Reporting by Christy ​Santhosh in Bengaluru; Editing by Leroy Leo

Our Standards: The Thomson Reuters Trust Principles., opens new tab

Key Takeaways Moderna outlined a strategy to expand its mRNA platform beyond vaccines into multiple therapies.Shares of the company rallied as Science Day spotlighted oncology, autoimmune and cell therapy programs.MRNA expects early-stage programs, including in vivo CAR-T and CAR-M therapies, to enter the clinic by 2027. Shares of Moderna (MRNA - Free Report) have surged 33.5% over the past week, adding nearly $8 billion to the company's market value.

The rally was sparked by Moderna's Science Day, where management outlined its vision to evolve beyond vaccines into a diversified biotechnology company. The event showcased how the company plans to leverage its messenger RNA (mRNA) platform across multiple therapeutic areas, including oncology, autoimmune diseases and cell therapy, while unveiling a new research and early development framework to accelerate pipeline innovation.

Moderna Leverages Its mRNA Platform Beyond VaccinesAs part of its long-term strategy, the company has grouped its business into three development horizons. Moderna emphasized that its commercial products, late-stage pipeline assets — including respiratory vaccine programs and its Merck (MRK - Free Report) -partnered personalized cancer therapy — as well as investigational rare disease therapies, represent Horizon 1, the foundation of its current business.

Beyond these established programs, Moderna introduced Horizon 2 and Horizon 3, underscoring its ambition to expand the application of its mRNA platform well beyond vaccines. Horizon 2 comprises emerging therapeutic modalities already in clinical development, including cancer antigen therapies, T-cell engagers, cell therapy enhancers and an investigational therapy for multiple sclerosis.

Horizon 3 comprises earlier-stage research programs that have not yet entered the clinic but are expected to advance into first-in-human studies before the end of 2027. These include in vivo CAR-T and CAR-M cell therapies, which could become the company's next-generation growth platforms.

Moderna is not alone in broadening the application of mRNA technology. The company’s rival BioNTech (BNTX - Free Report) is also leveraging its mRNA platform beyond vaccines and building an extensive pipeline across oncology and other disease areas to diversify its long-term growth prospects.

Why Investors Are Paying Attention to MRNA StockInvestors appear to have welcomed Moderna's efforts to expand the use of its mRNA platform beyond vaccines. Among the highlights was mRNA-6007, the company's first investigational in vivo CAR-T candidate for autoimmune diseases such as systemic lupus erythematosus (SLE), representing Moderna's entry into cell therapies. The program is part of the company's Horizon 3 pipeline, which management expects to advance into clinical studies by the end of 2027.

More broadly, the event underscored Moderna's strategy to use its mRNA platform to develop multiple classes of medicines spanning oncology, rare diseases, autoimmune disorders and cell therapies. By broadening the application of its mRNA platform across diverse therapeutic areas, the company aims to diversify future revenue streams beyond respiratory vaccines. The strategy appears to have resonated with investors, helping lift the stock to a 52-week high of $81.40.

MRNA’s Price Performance, Valuation & EstimatesShares of Moderna have skyrocketed more than 170% year today, significantly outperforming the industry’s 5.5% growth.

Image Source: Zacks Investment Research

From a valuation standpoint, the company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 13.16 times forward 12-month sales, higher than the industry average of 1.91 times.

Image Source: Zacks Investment Research

Estimates for Moderna’s 2026 and 2027 bottom line have declined over the past 60 days.

Image Source: Zacks Investment Research

Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Moderna Today

$70.03 +0.33 (+0.47%)

As of 06/30/2026 04:00 PM Eastern

52-Week Range$22.28▼

$73.28Price Target$37.13

Shares of Moderna NASDAQ: MRNA are behaving like it's 2020. The stock is up nearly 20% since the company’s Science Day event.

At that time, Moderna revealed its strategy for using mRNA to combat cancer and rare diseases. It’s a move beyond vaccines, and investors seem to like it.

Get Moderna alerts:

Looks, however, can be deceiving. Prior to the event, MRNA had short interest of over 16.5% which required over 10 days for short sellers to cover their positions.

The result? A classic short squeeze that has sent the stock to nearly double its consensus price target of around $37 as of June 30.

However, the price movement by itself isn’t disqualifying. The expansion of mRNA as a treatment for diseases is where the promise has always been. Therefore, investors are left with a decision ahead of its Q2 2026 earnings report, scheduled for July 30.

Why mRNA Still MattersThe promise of mRNA is that it changes how medicine gets made. Traditional drugs are manufactured in factories and injected into the body. mRNA medicines work differently. They deliver genetic instructions, and the body's own cells produce the protein needed to treat the disease.

That matters for two reasons. The same platform can be reprogrammed for different diseases by changing only the instructions. And that flexibility could make drug development faster and more efficient over time.

COVID-19 vaccines proved the platform works in infectious disease. The question Moderna is now trying to answer is whether the same approach can deliver meaningful results for cancer, autoimmune diseases, and rare diseases.

If the answer is yes, the platform becomes far more valuable than its vaccine franchise alone. That's the long-term story driving the recent move.

3 Horizons, 1 Long RunwayAt Science Day, Moderna organized its business into three "Horizons" that map how the platform scales over time.

Horizon 1 is Moderna’s commercial engine. It includes four approved vaccines (Spikevax, mRESVIA, mNEXSPIKE, and mCOMBRIAX), the investigational intismeran autogene cancer therapy, and a rare disease franchise led by a propionic acidemia treatment. This accounts for the bulk of the company’s current revenue.

Horizon 2 is the next wave. T-cell engagers targeting multiple myeloma and ovarian cancer, cancer antigen therapies for solid tumors and Lynch syndrome, and a multiple sclerosis therapeutic linked to the Epstein-Barr virus. Most are in Phase 1 or Phase 2 trials. The earliest meaningful readout is mRNA-1195 for multiple sclerosis, which is expected in the second half of 2026.

Horizon 3 is the long-term bet. The headline asset is mRNA-6007, an in vivo CAR-T therapy aimed at lupus. Moderna expects this to enter human trials by the end of 2027.

That’s a whole lot of potential. However, none of Horizon 2 or Horizon 3 will generate revenue until after 2028. Phase 1 and Phase 2 readouts are clinical milestones, not commercial ones. The path from trial to approval to launch takes years.

Why Caution Is WarrantedOn June 26, the day after Moderna’s Science Day event, Piper Sandler reiterated its Overweight rating on MRNA and raised its price target to $77 from $69. Even at the former price target, Piper Sandler was already one of the most bullish analysts.

It’s important to note, however, that the new price target doesn’t leave much upside for MRNA after its recent gains. Analysts may be holding off on issuing opinions until the company’s earnings report, especially since there won’t be any revenue or earnings from these new initiatives for several years.

That puts the entire burden on Horizon 1. The four approved vaccines, the intismeran Phase 3 program, and disciplined cash management have to fund the pipeline long enough for the platform story to pay off.

That’s why long-term investors who aren’t in the stock should wait for a better entry point. It’s also a reason for current shareholders to take some risk off the table.

Where the Squeeze Logically Gives BackThe most likely first pullback level is $60. It's a round-number psychological level and represents a healthy give-back of about half the move off the mid-June breakout. Pullbacks of that size are normal after a sharp rally; they are normal profit-taking and leave the bullish structure intact.  Anyone trimming into the squeeze would look to add back near this level.

The deeper, higher-conviction support is $55. That was the top of the April-to-June trading range, and the launch point of the Science Day breakout candle. Prior resistance becomes new support, and this is where the squeeze froth fully resets without breaking the thesis.

The line in the sand is $52, where the 50-day SMA sits at $51.83. A close below that level would mean the breakout has failed, and the stock has fallen back into the range it traded in before Science Day. At that point, the platform re-rate needs a fresh catalyst, such as the July 30 earnings report, to reassert itself.

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Key Takeaways Moderna outlined a three-horizon pipeline strategy to diversify beyond vaccines across new therapies.MRNA plans to advance its first in vivo CAR-T candidate into clinical studies by the end of 2027.Moderna highlighted AI integration to speed drug discovery and cited several upcoming clinical catalysts. Shares of Moderna (MRNA - Free Report) rose nearly 13% on Friday after the company unveiled a long-term strategy to transform itself from a vaccine-maker into a diversified biotechnology company.

Moderna Looks Beyond Its Vaccine BusinessAt its Science Day event, Moderna outlined plans to expand beyond its traditional vaccine business by leveraging its messenger RNA (mRNA) platform across multiple therapeutic areas.

To execute this strategy, the company has divided its pipeline into three horizons. Horizon 1 comprises its commercial products and late-stage pipeline assets, including the Merck (MRK - Free Report) -partnered personalized cancer therapy, intismeran autogene, and rare disease therapeutics.

Horizon 2 focuses on emerging clinical programs currently being evaluated in early-stage studies. These include cancer antigen therapies such as mRNA-4359, mRNA-4106 and mRNA-4200, along with T-cell engagers, cell therapy enhancers and an investigational therapy for multiple sclerosis.

In contrast, Horizon 3 or "future modalities," consists of earlier-stage research programs that have yet to enter the clinic. These include in vivo CAR-T and CAR-M cell therapies, which could become the company's next-generation growth platforms. As part of this horizon, Moderna unveiled mRNA-6007, its first in vivo CAR-T therapy, which it plans to develop for systemic lupus erythematosus (SLE) and other B-cell-mediated autoimmune diseases. The company expects to advance the candidate into clinical studies by the end of 2027.

MRNA Stock PerformanceThe broader pipeline strategy highlights Moderna's efforts to leverage its mRNA platform beyond vaccines and build multiple long-term growth franchises across oncology, rare diseases, autoimmune disorders and cell therapies. Investors appear to have welcomed this diversification strategy, helping lift the stock to a 52-week high of $69.29.

Year to date, the stock has skyrocketed 128% compared with the industry’s 5% growth.

Image Source: Zacks Investment Research

Moderna Explores AI to Accelerate Drug DiscoveryBeyond expanding its pipeline, Moderna also highlighted plans to expand its use of artificial intelligence (AI) to accelerate drug discovery and development. The company is integrating AI, machine learning and platform data to improve target identification, optimize molecule design and streamline clinical development.

Management believes these capabilities will help improve R&D productivity and support the development of future mRNA-based medicines across multiple therapeutic areas.

Upcoming Catalysts Drive MRNA StockSeveral near-term catalysts could support Moderna’s long-term growth strategy. These include a potential FDA approval of its seasonal influenza vaccine, which is expected early next month.

Investors will also be watching several important clinical milestones that could serve as catalysts for the stock over the coming quarters. These include phase III data on intismeran in melanoma, a readout from the company's late-stage norovirus vaccine program and data from the registrational study evaluating its propionic acidemia candidate.

MRNA’s Zacks RankModerna currently carries a Zacks Rank #3 (Hold).

Key Picks Among Biotech StocksSome better-ranked stocks from the sector are Immunocore (IMCR - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost nearly 11% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.

Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.56 to $4.27. INDV’s shares are up nearly 17% year to date.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.

Moderna (MRNA 1.03%) has been on fire this year. As of this writing, the company's shares have slightly more than doubled to date. What's more, the biotech has an important catalyst on the horizon. Let's find out whether there is any upside left for the company.

Image source: Getty Images.

Racing toward an approval Moderna has been working on an influenza vaccine, mRNA-1010. It submitted regulatory applications for this candidate earlier this year. The U.S. Food and Drug Administration (FDA) should approve or reject Moderna's application by Aug. 5. It's an important date for the biotech company, as an approval in this field might allow it to establish itself as a leader in the flu market. True, plenty of flu vaccines exist, but their efficacy is usually not very impressive, typically between 40% to 60% in the U.S. In phase 3 studies, mRNA-1010 performed better than approved vaccines in patients aged 50 and older who tend to be more at risk of severe cases of the disease, hospitalization, and death.

And if there was any doubt about whether mRNA-1010 would get the FDA's green light, recent developments have made that outcome practically certain. Members of an advisory committee convened by the FDA to give their opinion on whether mRNA-1010 should earn approval unanimously voted in favor. The health regulatory agency doesn't always follow the advice of these experts, but it almost always does. It would be surprising if mRNA-1010 doesn't get the nod.

Today's Change

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-0.62

Current Price

$

59.80

What does this mean for the stock? Moderna's shares soared after the advisory committee's vote of confidence for mRNA-1010. So, it's likely the market has already priced in a positive outcome, and the stock won't move much once mRNA-1010 is approved. However, there are still good reasons to invest in Moderna. The company is once again demonstrating its innovative qualities with mRNA-1010, just as it did with its coronavirus vaccine, which became a leader in that niche. The flu vaccine market isn't that large. According to some estimates, it was worth $8.9 billion last year, although it will continue growing at a good clip for the foreseeable future. Moderna's potential sales in this niche alone do not justify its $24.5 billion market cap, especially given that it generates meager revenue from its currently approved products.

That said, the vaccine maker has a rich pipeline with several products that could become key growth drivers. For instance, Moderna is developing mRNA-4157, an investigational personalized cancer vaccine that has shown highly encouraging clinical trial results and is now undergoing several phase 2 and phase 3 studies. Moderna is also going after difficult targets. The company is developing an HIV vaccine. Moderna's success in the flu vaccine market will help it pursue even more lucrative markets. Over the next five years, the company could have a much broader portfolio of approved products while generating strong revenue and earnings. That's why Moderna's shares are still attractive, even after climbing by about 100% this year.

FDA Advisory Committee To Review Moderna Flu Vaccine ApplicationThe company submitted an application in December 2025 for mFlusiva (mRNA-1010), an mRNA-based trivalent influenza vaccine.

The VRBPAC panel’s vote will focus on the risk-benefit profile of mFlusiva for influenza prevention in adults aged 50 to 64 years, and in the 65-year-and-older population.

The briefing document released on Tuesday identified no major deficiencies.

The primary efficacy analysis demonstrated that mRNA-1010 (TIV) met all prespecified sequential success criteria—noninferiority, superiority, and super-superiority—relative to the standard-dose (SD) comparator.

Questions Around Comparator Choice And Clinical DataThe VRBPAC members will consider whether the standard-dose flu vaccine used as the control was the most appropriate comparator. High-dose, recombinant, and adjuvanted flu vaccines are generally preferred for adults 65 and older.

FDA Decision Timeline And Proposed Approval StrategyFollowing a Type A meeting, the FDA assigned a Prescription Drug User Fee Act goal date of August 5 for mRNA-1010. It’s for adults aged 50 and older.

Moderna proposed a regulatory pathway based on age, seeking full approval for adults aged 50 to 64 and accelerated approval for adults 65 and older, along with a postmarketing requirement to conduct an additional study in older adults.

Moderna Analyst Sees Opportunity But Flags Some UncertaintiesWilliam Blair noted that the scope of Moderna's postmarketing commitments remains unclear. The company's willingness to fund potentially costly Phase IV studies are important given management's guidance to limit additional spending on its respiratory vaccine franchise.

Analyst Myles Minter said mFluSiva could become a meaningful driver of Moderna's revenue growth in 2027 if approved.

However, Minter maintained a Market Perform rating, citing the need for greater visibility into Phase 3 INTERPATH-001 data for intismeran in adjuvant melanoma, expected in 2026, which he views as a more significant long-term catalyst for the stock.

MRNA Stock Price Activity: Moderna shares rose 1.19% at $56.06 during premarket trading on Wednesday, according to Benzinga Pro data.

Photo: pcruciatti / Shutterstock

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