Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Get insights on thousands of stocks from the global community of over 7 million individual investors at Simply Wall St.

For investors considering whether Merck at around US$120.76 still offers value or whether most of the upside is already reflected in the price, this article walks through the key checks investors often rely on. With the stock showing returns of 0.4% over 7 days, 7.5% over 30 days, 13.4% year to date and 53.0% over 1 year, many holders are now asking whether the current price fairly reflects the business. Recent headlines around Merck have focused on its position as a major pharmaceuticals player, ongoing product pipelines and broader sector sentiment. These factors can all influence how investors think about risk and potential, and together they often shape how much of a premium or discount the market is willing to place on the shares. On Simply Wall St’s valuation checks, Merck currently has a value score of 3 out of 6. This article will compare different valuation approaches and then finish by outlining a more holistic way to think about what the stock might be worth.

Merck delivered 53.0% returns over the last year. See how this stacks up to the rest of the Pharmaceuticals industry.

Approach 1: Merck Discounted Cash Flow (DCF) Analysis

A Discounted Cash Flow, or DCF, model takes estimates of the cash a company could generate in the future and discounts them back to today, so you can compare that stream of cash to the current share price.

For Merck, Simply Wall St uses a 2 Stage Free Cash Flow to Equity model. The latest twelve month free cash flow is about $14.0b. Analyst sourced projections extend out several years, with total free cash flow for 2030 shown at $24.6b, and the model then extrapolates further years based on those inputs.

Using these projected cash flows, the DCF model arrives at an estimated intrinsic value of $228.62 per share. Against the recent price of about $120.76, this implies the stock is 47.2% undervalued according to this approach.

This result suggests the cash flow outlook embedded in the model is more optimistic than what the current market price reflects. As a result, the DCF points to meaningful upside potential if those projections play out.

Result: UNDERVALUED

Our Discounted Cash Flow (DCF) analysis suggests Merck is undervalued by 47.2%. Track this in your watchlist or portfolio, or discover 46 more high quality undervalued stocks.MRK Discounted Cash Flow as at Jun 2026

Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for Merck.

Approach 2: Merck Price vs Earnings

For established, profitable companies like Merck, the P/E ratio is a common way to think about value because it links what you pay for each share to the earnings that support that price. Higher growth expectations and lower perceived risk usually justify a higher P/E, while slower growth or higher risk tend to pull a “normal” or “fair” P/E lower.

Story Continues

Merck currently trades on a P/E of 33.38x. That sits above the Pharmaceuticals industry average of 15.07x and also above the peer group average of 26.03x. On its own, this might suggest investors are willing to pay a premium.

Simply Wall St’s Fair Ratio for Merck is 33.40x. This is a proprietary estimate of the P/E that might be reasonable given factors such as earnings growth, profit margins, industry, market cap and company specific risks. Because it blends these elements, the Fair Ratio can often be more tailored than a simple comparison with industry or peer averages, which do not adjust for Merck’s specific profile.

The actual P/E of 33.38x sits very close to the Fair Ratio of 33.40x, indicating the stock is priced at roughly the level this framework would suggest.

Result: ABOUT RIGHTNYSE:MRK P/E Ratio as at Jun 2026

P/E ratios tell one story, but what if the real opportunity lies elsewhere? Start investing in legacies, not executives. Discover our 20 top founder-led companies.

Upgrade Your Decision Making: Choose your Merck Narrative

Earlier it was mentioned that there is an even better way to understand valuation, so Narratives bring that to life by letting you attach a clear story about Merck to your numbers, including your view on future revenue, earnings and margins, then linking that story to a forecast and a Fair Value you can compare with today’s price.

On Simply Wall St’s Community page, Narratives are available as an easy tool used by millions of investors. You can see, for example, one Merck Narrative built around a higher Fair Value near US$150 that leans on oncology pipeline potential and margin expansion, alongside a more cautious Narrative closer to US$101 that focuses on pricing pressure, Keytruda reliance and M&A execution risks.

Each Narrative ties these assumptions into a Fair Value that updates when new information such as news, earnings or deal announcements is added. This helps you decide whether the current price looks high, low or close to your own view and whether that supports buying, holding or waiting according to your personal approach.

For Merck however we will make it really easy for you with previews of two leading Merck Narratives:

Taken together, these give you a clear bull and bear framing that you can stress test against your own expectations for earnings, margins and the oncology pipeline.

🐂 Merck Bull Case

Fair Value: US$129.74 per share

Implied undervaluation vs last close: about 6.9% below this Fair Value

Analyst revenue growth assumption: 5.15% a year

Analysts see oncology and related acquisitions, including the Terns deal, as key to supporting future earnings, with over 20 potential growth drivers and a much larger late phase pipeline compared with a few years ago. Their models assume higher net profit margins over time, supported by R&D, new product launches such as WINREVAIR and CAPVAXIVE, and sizeable manufacturing projects that could improve efficiency. This camp judges that, at around US$120.76, the stock sits modestly below its Fair Value, so the current price is broadly in line with the consensus view that Merck is close to fairly priced on these earnings and margin assumptions.

🐻 Merck Bear Case

Fair Value: US$101.30 per share

Implied overvaluation vs last close: about 19.2% above this Fair Value

Analyst revenue growth assumption: 3.14% a year

The more cautious analysts focus on pricing pressure, regulatory risk and eventual patent expiries, especially around KEYTRUDA, and see these as constraints on how much Merck can grow revenue and earnings. They build in slower revenue growth and only modest margin expansion, with a lower future P/E multiple that reflects concerns about competition from biosimilars, generics and potential policy driven price cuts. On this view, a share price around US$120.76 sits well above Fair Value, so these analysts regard the market as pricing in more optimism than their numbers support.

Both Narratives rely on explicit assumptions for revenue, margins, valuation multiples and discount rates, so your next step is to decide which set of assumptions feels closer to your own view of Merck's oncology pipeline, pricing power and acquisition execution, or whether your story sits somewhere in between the two.

To see how the wider community is weighing these trade offs and where your own view fits on that spectrum, it is worth reviewing the full range of Narratives that investors have already built for this stock, including bull, bear and blended cases, and then adjusting the inputs to match your personal thesis, time horizon and risk tolerance.

To see how these results tie into long-term growth, risks, and valuation, check out the full range of community narratives for Merck on Simply Wall St. Add the company to your watchlist or portfolio so you'll be alerted when the story evolves.

Do you think there's more to the story for Merck? Head over to our Community to see what others are saying!NYSE:MRK 1-Year Stock Price Chart

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include MRK.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Marks the first approved combinations of a PD-1 and HIF-2α inhibitor

Approvals based on Phase 3 LITESPARK-022 trial that showed KEYTRUDA in combination with WELIREG reduced the risk of disease recurrence, metastasis or death by 28% compared to KEYTRUDA plus placebo

Represents the first and only global Phase 3 study to have demonstrated an improvement in disease-free survival over KEYTRUDA monotherapy in adjuvant ccRCC

RAHWAY, N.J., June 12, 2026--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with WELIREG® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2α inhibitor combination regimens.

The approvals are based on results from the pivotal Phase 3 LITESPARK-022 trial. LITESPARK-022 enrolled 1,841 patients and demonstrated that KEYTRUDA in combination with WELIREG significantly improved disease-free survival (DFS), the trial’s primary endpoint, reducing the risk of disease recurrence, metastasis or death by 28% (HR=0.72 [95% CI 0.59-0.87]; p=0.0003) for patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions compared to KEYTRUDA plus placebo. The estimated 24-month DFS rate was 81% (95% CI 0.78-0.83) with KEYTRUDA plus WELIREG compared to 74% (95% CI 0.71-0.77) with KEYTRUDA plus placebo. Median DFS was not reached in either arm. Overall survival (OS) results were not yet mature at this interim analysis. The effectiveness of KEYTRUDA QLEX for its approved indications has been established based upon evidence from the adequate and well-controlled studies conducted with KEYTRUDA and additional data from MK-3475A-D77 comparing the pharmacokinetic, efficacy, and safety profiles of KEYTRUDA QLEX and KEYTRUDA.

The WELIREG prescribing information contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception. WELIREG can render some hormonal contraceptives ineffective. WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen or hospitalization. Monitor oxygen saturation before initiation of, and periodically throughout, treatment with WELIREG. For more information, see "Selected Safety Information" below.

Story Continues

KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients. KEYTRUDA and KEYTRUDA QLEX are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions in any or multiple organs, which can occur during or after treatment, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, other transplant (including corneal graft) rejection; severe and life-threatening infusion or injection-related reactions; fatal and other serious complications in patients who receive allogeneic hematopoietic stem cell transplantation before or after beginning treatment; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when KEYTRUDA or KEYTRUDA QLEX is added to a thalidomide analogue plus dexamethasone, which is not recommended outside of controlled trials. Immune-mediated adverse reactions listed here may not include all such possible severe or fatal reactions. For more information, see "Selected Safety Information" below.

"Patients with earlier-stage renal cell carcinoma at high risk of recurrence after surgery may see their cancer return, frequently as metastatic disease," said Dr. Toni K. Choueiri, director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg professor of medicine, Harvard Medical School. "The results of the LITESPARK-022 trial demonstrated the ability of pembrolizumab in combination with belzutifan to reduce the risk of disease recurrence, metastasis, or death by 28%, which represents an important new option for these patients to help keep their clear cell renal cell carcinoma from coming back."

"Reflecting on my own experience as a clinical oncologist, I know the significant impact that improved disease-free survival can have on the lives of patients," said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. "These approvals demonstrate Merck’s commitment to pursuing innovative treatment options that may help these patients experience longer periods without disease."

"The FDA approval of the novel KEYTRUDA and WELIREG combination is exciting news for the kidney cancer community," said Bryan Lewis, CEO and co-founder, KidneyCan. "This progress reflects an important step in addressing the needs of patients with earlier-stage renal cell carcinoma."

Study design and additional data from LITESPARK-022

LITESPARK-022 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05239728) evaluating WELIREG in combination with KEYTRUDA compared to placebo plus KEYTRUDA for the adjuvant treatment of ccRCC post nephrectomy. Eligible patients had intermediate-high or high risk of recurrence of RCC, or M1 no evidence of disease (NED). Patients must have undergone a partial or radical nephrectomy, and if indicated, metastasectomy within two years of nephrectomy, within ≥4 weeks prior to the time of screening. Patients were excluded from the trial if they had received prior systemic therapy for advanced RCC. The trial enrolled 1,841 patients who were randomized (1:1) to receive either:

WELIREG (120 mg orally once daily) plus KEYTRUDA (400 mg intravenously [IV] every six weeks) for up to 9 cycles (54 weeks) until disease recurrence or unacceptable toxicity (n=921), or; KEYTRUDA (400 mg IV every six weeks) plus oral placebo for up to 9 cycles (54 weeks) until disease recurrence or unacceptable toxicity (n=920).

The major efficacy outcome measure was investigator-assessed DFS and an additional outcome measure was OS.

The safety of WELIREG in combination with KEYTRUDA was evaluated in LITESPARK-022. A total of 915 patients received WELIREG in combination with KEYTRUDA and a total of 913 patients received oral placebo in combination with KEYTRUDA. The median duration of exposure to WELIREG was 12.4 months (range 1 day to 20.1 months). The median duration of exposure to KEYTRUDA in the treatment arm was 11.1 months (range: 1 day to 16.1 months).

Serious adverse reactions occurred in 30% of patients who received WELIREG in combination with KEYTRUDA. The most frequently reported serious adverse reactions (≥1%) were pneumonia (2%), hypoxia (1.9%), pneumonitis (1.6%), arrhythmia (1.5%), diarrhea (1.1%), and acute kidney injury (1.1%). Fatal adverse reactions occurred in 1.1% of patients who received WELIREG in combination with KEYTRUDA, including sepsis (0.1%).

WELIREG was permanently discontinued due to adverse reactions in 27% of patients. Adverse reactions which resulted in permanent discontinuation of WELIREG in ≥1% of patients included anemia (4%), fatigue (2.2%), rash (2%), increased alanine aminotransferase (ALT) (1.7%), hypoxia (1.6%), diarrhea (1.4%), pneumonitis (1.3%), increased aspartate aminotransferase (AST) (1.1%), and hepatic function abnormal (1%).

KEYTRUDA was permanently discontinued due to adverse reactions in 23% of patients. Adverse reactions which resulted in permanent discontinuation of KEYTRUDA in ≥1% of patients included increased ALT (4.5%), increased AST (3%), pneumonitis (2.4%), diarrhea (2.4%), and rash (1.5%).

Dosage interruptions of WELIREG due to an adverse reaction occurred in 52% of patients. Of the patients who received WELIREG in combination with KEYTRUDA, 30% were ≥65 years old and 5% were ≥75 years old. Dose interruptions of WELIREG occurred in 57% of patients ≥65 years of age and in 49% of younger patients. Adverse reactions which required dosage interruption of WELIREG in ≥2% of patients included anemia (25%), fatigue (3.7%), increased ALT (3.5%), diarrhea (3.4%), increased AST (3.4%), COVID-19 (2.6%), hypoxia (2.5%), pyrexia (2.5%), musculoskeletal pain (2.1%), and rash (2.1%).

Dose interruptions of KEYTRUDA due to an adverse reaction occurred in 29% of patients. Adverse reactions which required dosage interruption of KEYTRUDA in ≥2% of patients included anemia (3.2%), diarrhea (3%), increased ALT (3%), and increased AST (2.5%).

Dose reductions of WELIREG due to an adverse reaction occurred in 34% of patients. Dose reductions of WELIREG occurred in 39% of patients ≥65 years of age and in 32% of younger patients. Adverse reactions which required dose reduction in ≥3% of patients included anemia (17%), hypoxia (3.5%), increased ALT (3.2%), and fatigue (3.1%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, in patients who received WELIREG in combination with KEYTRUDA were decreased hemoglobin (95%), increased ALT (57%), fatigue (49%), increased AST (46%), decreased lymphocytes (38%), and increased alkaline phosphatase (29%).

About renal cell carcinoma

Renal cell carcinoma (RCC) is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths from the disease worldwide. In the U.S., it is estimated there will be more than 80,000 new cases of kidney cancer diagnosed and more than 15,000 deaths from the disease in 2026. Renal cell carcinoma is about twice as common in men as in women. Cases of RCC might be discovered incidentally during imaging tests for other reasons. Clear cell renal cell carcinoma, which accounts for 70% of RCC diagnoses, is the most common subtype.

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 Merck’s research in genitourinary cancers

Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 ongoing clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers.

About WELIREG® (belzutifan) 40 mg tablets, for oral use

WELIREG, Merck’s first-in-class hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, is an orally administered small-molecule that in conditions of hypoxia or impairment of VHL protein function, blocks HIF-2alpha and HIF-1beta interaction, which may reduce the transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth. By inhibiting HIF-2α signaling, WELIREG may disrupt key pathways certain tumors may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumor survival.

WELIREG has received prior regulatory approvals in certain patients with von Hippel-Lindau (VHL) disease-associated tumors, advanced renal cell carcinoma with a clear cell component (ccRCC) and pheochromocytoma or paraganglioma (PPGL). As part of a broader clinical program, Merck continues to research WELIREG for people with RCC and selected solid tumors across different treatment settings, to further understand where WELIREG may provide clinical benefit.

Indications for WELIREG (belzutifan) in the U.S.

von Hippel-Lindau (VHL) disease

WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

Renal Cell Carcinoma with a Clear Cell Component (ccRCC)

WELIREG, in combination with KEYTRUDA or KEYTRUDA QLEX, is indicated for the adjuvant treatment of adult patients with ccRCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

WELIREG is indicated for the treatment of adult patients with advanced ccRCC following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Pheochromocytoma or Paraganglioma (PPGL)

WELIREG is indicated for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).

Selected Safety Information for WELIREG

Warning: Embryo-Fetal Toxicity

Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective.

Anemia

WELIREG can cause severe anemia that can require blood transfusion.

Monitor for anemia before initiation of, and periodically throughout, treatment with WELIREG. Transfuse patients as clinically indicated. Withhold, reduce dose, or permanently discontinue WELIREG based on severity.

In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months).

The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established.

In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced ccRCC and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs.

In LITESPARK-022 (n=915), decreased hemoglobin occurred in 95% of patients receiving adjuvant treatment for ccRCC and 11% had Grade 3 or higher events. Median time to onset of anemia was 42 days (range: 1 day to 11.1 months). Of the patients with anemia, 5% received transfusions only, 8% received ESAs only, and 1.3% received both transfusion and ESAs.

In LITESPARK-015 (n=72), anemia occurred in 96% of patients with PPGL and 22% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 22.1 months). Of the patients with anemia, 20% received transfusions only, 26% received ESAs only, and 6% received both transfusion and ESAs.

Hypoxia

WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.

Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose. For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a health care provider.

In LITESPARK-004, hypoxia occurred in 1.6% of patients with VHL disease.

In LITESPARK-005, hypoxia occurred in 15% of patients with advanced ccRCC and 10% had Grade 3 events. Of the patients with hypoxia, 69% were treated with oxygen therapy. Median time to onset of hypoxia was 30.5 days (range: 1 day to 21.1 months).

In LITESPARK-022, hypoxia occurred in 7% of patients receiving adjuvant treatment for ccRCC and 5% had Grade 3 or higher events. Of the patients with hypoxia, 47% were treated with oxygen therapy. Median time to onset of hypoxia was 93 days (range: 9 days to 11.7 months).

In LITESPARK-015, hypoxia occurred in 13% of patients with PPGL and 10% had Grade 3 hypoxia. Median time to onset of hypoxia was 35 days (range: 6 days to 23.9 months). Of the patients with hypoxia, 67% were treated with oxygen therapy.

Embryo-Fetal Toxicity

Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman.

Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Adverse Reactions

Adverse Reactions in LITESPARK-004 (VHL Disease)

Serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each).

WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness.

Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%).

The most common adverse reactions (≥25%), including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin (93%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%).

Adverse Reactions in LITESPARK-022 (Adjuvant ccRCC)

Serious adverse reactions occurred in 30% of patients receiving WELIREG in combination with KEYTRUDA. The most frequently reported serious adverse reactions (≥1%) were pneumonia (2%), hypoxia (1.9%), pneumonitis (1.6%), arrhythmia (1.5%), diarrhea (1.1%), and acute kidney injury (1.1%). Fatal adverse reactions occurred in 1.1% of patients who received WELIREG in combination with KEYTRUDA, including sepsis (0.1%).

WELIREG was permanently discontinued due to adverse reactions in 27% of patients. Adverse reactions which resulted in permanent discontinuation of WELIREG in ≥1% of patients included anemia (4%), fatigue (2.2%), rash (2%), increased alanine aminotransferase (ALT) (1.7%), hypoxia (1.6%), diarrhea (1.4%), pneumonitis (1.3%), increased aspartate aminotransferase (AST) (1.1%), and hepatic function abnormal (1%).

Dosage interruptions of WELIREG due to an adverse reaction occurred in 52% of patients. Of the patients who received WELIREG in combination with KEYTRUDA, 30% were ≥65 years old and 5% were ≥75 years old. Dose interruptions of WELIREG occurred in 57% of patients ≥65 years of age and in 49% of younger patients. Adverse reactions which required dosage interruption of WELIREG in ≥2% of patients included anemia (25%), fatigue (3.7%), increased ALT (3.5%), diarrhea (3.4%), increased AST (3.4%), COVID-19 (2.6%), hypoxia (2.5%), pyrexia (2.5%), musculoskeletal pain (2.1%), and rash (2.1%).

Dose reductions of WELIREG due to an adverse reaction occurred in 34% of patients. Dose reductions of WELIREG occurred in 39% of patients ≥65 years of age and in 32% of younger patients. Adverse reactions which required dose reduction in ≥3% of patients included anemia (17%), hypoxia (3.5%), increased ALT (3.2%), and fatigue (3.1%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, in patients who received WELIREG in combination with KEYTRUDA were decreased hemoglobin (95%), increased ALT (57%), fatigue (49%), increased AST (46%), decreased lymphocytes (38%), and increased alkaline phosphatase (29%).

Adverse Reactions in LITESPARK-005 (Advanced ccRCC)

Serious adverse reactions occurred in 38% of patients. The most frequently reported serious adverse reactions (≥2%) were hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%), and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of patients who received WELIREG, including sepsis (0.5%) and hemorrhage (0.5%).

WELIREG was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions which resulted in permanent discontinuation (≥0.5%) were hypoxia (1.1%), anemia (0.5%), and hemorrhage (0.5%).

Dosage interruptions due to an adverse reaction occurred in 39% of patients. Of the patients who received WELIREG, 28% were 65 to 74 years, and 10% were 75 years and over. Dose interruptions occurred in 48% of patients ≥65 years of age and in 34% of younger patients. Adverse reactions which required dosage interruption in ≥2% of patients were anemia (8%), hypoxia (5%), COVID-19 (4.3%), fatigue (3.2%), and hemorrhage (2.2%).

Dose reductions due to an adverse reaction occurred in 13% of patients. Dose reductions occurred in 18% of patients ≥65 years of age and in 10% of younger patients. The most frequently reported adverse reactions which required dose reduction (≥1.0%) were hypoxia (5%) and anemia (3.2%).

The most common adverse reactions (≥25%), including laboratory abnormalities, were decreased hemoglobin (88%), fatigue (43%), musculoskeletal pain (34%), increased creatinine (34%), decreased lymphocytes (34%), increased alanine aminotransferase (32%), decreased sodium (31%), increased potassium (29%), and increased aspartate aminotransferase (27%).

Adverse Reactions in LITESPARK-015 (PPGL)

Serious adverse reactions occurred in 36% of patients. The most frequently reported serious adverse reactions (≥2%) were anemia and hypertension (4.2% each) and pyelonephritis, pneumonia, hypoxia, dyspnea and hemorrhage (2.8% each).

WELIREG was permanently discontinued due to adverse reactions in 2 patients (2.8%). Adverse reactions which resulted in permanent discontinuation were increased alanine aminotransferase and paraparesis (1.4% each).

Dosage interruptions due to an adverse reaction occurred in 40% of patients. Of the patients who received WELIREG, 13% were ≥65 years old and 4.2% were ≥75 years. Adverse reactions which required dosage interruption in >3% of patients were hypoxia, nausea, and fatigue (4.2% each).

Dose reductions due to an adverse reaction occurred in 14% of patients. The most frequently reported adverse reaction which required dose reduction was hypoxia (4.2%).

The most common (≥25%) adverse reactions, including laboratory abnormalities, that occurred in patients were anemia (96%), fatigue (56%), musculoskeletal pain (56%), decreased lymphocytes (54%), increased alanine aminotransferase (51%), increased aspartate aminotransferase (42%), increased calcium (34%), dyspnea (33%), increased potassium (31%), decreased leukocytes (30%), headache (29%), increased alkaline phosphatase (25%), dizziness (26%) and nausea (25%).

Drug Interactions

Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended.

Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding.

Lactation

Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose.

Females and Males of Reproductive Potential

WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG.

Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose.

Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown.

Pediatric Use

Use of WELIREG in pediatric patients aged 12 years and older is supported by evidence from an adequate and well-controlled study of WELIREG in adults with additional pharmacokinetic data demonstrating that belzutifan exposure is predicted to be within range of that observed in adults, and that the course of locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma is sufficiently similar in adults and pediatric patients to allow extrapolation of data in adults to pediatric patients.

The safety and effectiveness of WELIREG have not been established in patients with VHL or ccRCC, or in pediatric patients younger than 12 years of age with PPGL.

Renal Impairment

For patients with severe renal impairment (eGFR 15-29 mL/min estimated by MDRD), monitor for increased adverse reactions and modify the dosage as recommended.

Hepatic Impairment

For patients with moderate and severe hepatic impairment, monitor for increased adverse reactions and modify the dosage as recommended.

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.

About KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use, 165 mg + 2,000 units/mL

KEYTRUDA QLEX is a fixed-combination drug product of pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody and berahyaluronidase alfa enhances dispersion and permeability to enable subcutaneous administration of pembrolizumab. KEYTRUDA QLEX is administered as a subcutaneous injection into the thigh or abdomen, avoiding the 5 cm area around the navel, over one minute every three weeks (2.4 mL) or over two minutes every six weeks (4.8 mL).

Selected Indications in the U.S. for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph)

Renal Cell Carcinoma

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

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

KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with WELIREG, for the adjuvant treatment of adult patients with RCC with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

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

Selected Safety Information for KEYTRUDA and KEYTRUDA QLEX

Contraindications

KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to berahyaluronidase alfa, hyaluronidase or to any of its excipients.

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA and KEYTRUDA QLEX are monoclonal antibodies that belong 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 or KEYTRUDA QLEX 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 and KEYTRUDA QLEX depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA and KEYTRUDA QLEX require 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 and KEYTRUDA QLEX 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. Immune-mediated pneumonitis occurred in 5% (13/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including fatal (0.4%), Grade 3 (2%), and Grade 2 (1.2%) adverse reactions.

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 and KEYTRUDA QLEX 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. Immune-mediated colitis occurred in 1.2% (3/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 3 (0.8%) and Grade 2 (0.4%) adverse reactions.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA and KEYTRUDA QLEX 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. Immune-mediated hepatitis occurred in 0.4% (1/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 2 (0.4%) adverse reactions.

KEYTRUDA With Axitinib or KEYTRUDA QLEX With Axitinib

KEYTRUDA and KEYTRUDA QLEX, when either is used 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 or KEYTRUDA QLEX 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 and KEYTRUDA QLEX can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA and KEYTRUDA QLEX 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. Adrenal insufficiency occurred in 2% (5/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 3 (0.4%) and Grade 2 (0.8%) adverse reactions.

Hypophysitis

KEYTRUDA and KEYTRUDA QLEX 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 and KEYTRUDA QLEX 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 and KEYTRUDA QLEX 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 and KEYTRUDA QLEX 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 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.

Thyroiditis occurred in 0.4% (1/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 2 (0.4%). Hyperthyroidism occurred in 8% (20/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 2 (3.2%). Hypothyroidism occurred in 14% (35/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 2 (11%).

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 and KEYTRUDA QLEX 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. Type 1 DM occurred in 0.4% (1/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA and KEYTRUDA QLEX 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 and KEYTRUDA QLEX 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 and KEYTRUDA QLEX 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. Immune-mediated dermatologic adverse reactions occurred in 1.6% (4/251) of patients receiving KEYTRUDA QLEX in combination with chemotherapy, including Grade 4 (0.8%) and Grade 3 (0.8%) adverse reactions.

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, KEYTRUDA QLEX, 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 (2.8%), 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.

Hypersensitivity and Infusion- or Administration-Related Reactions

KEYTRUDA and KEYTRUDA QLEX can cause severe or life-threatening administration-related reactions, including hypersensitivity and anaphylaxis. With KEYTRUDA and KEYTRUDA QLEX, monitor for signs and symptoms of infusion- and administration-related systemic reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. Infusion-related reactions have been reported in 0.2% of 2799 patients receiving KEYTRUDA. 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. Hypersensitivity and administration related systemic reactions occurred in 3.2% (8/251) of patients receiving KEYTRUDA QLEX in combination with platinum doublet chemotherapy, including Grade 2 (2.8%). Interrupt injection (if not already fully administered) and resume if symptoms resolve for mild or moderate systemic reactions. For severe or life-threatening systemic reactions, stop injection and permanently discontinue KEYTRUDA QLEX.

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 their mechanism of action, KEYTRUDA and KEYTRUDA QLEX can each 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 or KEYTRUDA QLEX and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In study MK-3475A-D77, when KEYTRUDA QLEX was administered with chemotherapy in metastatic non–small cell lung cancer (NSCLC), serious adverse reactions occurred in 39% of patients. Serious adverse reactions in ≥1% of patients who received KEYTRUDA QLEX were pneumonia (10%), thrombocytopenia (4%), febrile neutropenia (4%), neutropenia (2.8%), musculoskeletal pain (2%), pneumonitis (2%), diarrhea (1.6%), rash (1.2%), respiratory failure (1.2%), and anemia (1.2%). Fatal adverse reactions occurred in 10% of patients including pneumonia (3.2%), neutropenic sepsis (2%), death not otherwise specified (1.6%), respiratory failure (1.2%), parotitis (0.4%), pneumonitis (0.4%), pneumothorax (0.4%), pulmonary embolism (0.4%), neutropenic colitis (0.4%), and seizure (0.4%). KEYTRUDA QLEX was permanently discontinued due to an adverse reaction in 16% of 251 patients. Adverse reactions which resulted in permanent discontinuation of KEYTRUDA QLEX in ≥2% of patients included pneumonia and pneumonitis. Dosage interruptions of KEYTRUDA QLEX due to an adverse reaction occurred in 45% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included neutropenia, anemia, thrombocytopenia, pneumonia, rash, and increased aspartate aminotransferase. The most common adverse reactions (≥20%) were nausea (25%), fatigue (25%), and musculoskeletal pain (21%).

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-A39, when KEYTRUDA was administered in combination with enfortumab vedotin 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; 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 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-905, the most common adverse reactions (≥20%) occurring in cisplatin-ineligible patients with MIBC treated with KEYTRUDA in combination with enfortumab vedotin (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%), urinary tract infection (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 urinary tract infection (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), increased alanine aminotransferase, increased aspartate aminotransferase, diarrhea, dysgeusia, and toxic epidermal necrolysis (1.2% each). Of the 167 patients in the KEYTRUDA in combination with enfortumab vedotin arm who received neoadjuvant treatment, 7 (4.2%) patients 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, urinary tract infection, 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 and underwent radical cystectomy, 6 (4.1%) patients 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 43% (n=100) of patients; the most frequent (≥2%) were urinary tract infection (8%); acute kidney injury and pyelonephritis (5% each); urosepsis (4%); and hypokalemia, intestinal obstruction, and sepsis (2% 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 28% of patients; the most frequent (>1%) 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 p

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Bristol Myers Squibb BMY is navigating a revenue mix shift as growth products portfolio now assumes a larger role in the business, helping mitigate the impact of declining sales from mature products facing generics.

The growth portfolio — including Opdivo, Opdivo Qvantig, Orencia, Yervoy, Reblozyl, Camzyos, Breyanzi, Opdualag, Zeposia, Sotyku, Krazati and Cobenfy — is becoming central to top-line resilience. Sales from this segment rose 12% in the first quarter of 2026, lifting its contribution to 54% of total revenues from 49.7% in the first quarter of 2025. This shift signals improving revenue durability and supports a more favorable long-term growth outlook.

Within this mix, Reblozyl, Breyanzi, Opdualag, Qvantig and Cobenfy propelled growth in the first quarter.

Opdivo Qvantig (nivolumab and hyaluronidase-nvhy- subcutaneous formulation) has witnessed strong uptake across all approved tumor types in the United States.

Other key drugs are contributing to revenue growth, though at varying stages of maturity.

Opdualag sales remain robust, particularly in the United States, where it continues to serve as a standard of care in first-line melanoma.

Reblozyl recorded strong sales growth, driven by continued adoption in both first-line and second-line treatment settings for patients with myelodysplastic syndrome (MDS)-associated anemia.

Breyanzi continues to deliver solid growth, driven by ongoing uptake across its approved large B-cell lymphoma indications in both the United States and international markets. The strong performance highlights sustained demand for the therapy and supports expectations for continued commercial expansion.

Camzyos continues to gain traction in the cardiovascular market, supported by growing demand and increased adoption among eligible patients.

In immunology, Sotyktu remains an important growth driver. The recent approval in psoriatic arthritis expands its commercial opportunity and strengthens BMY's presence in rheumatology. Additional upside could come from ongoing phase III programs in systemic lupus erythematosus and Sjögren's disease, which may further broaden the drug's addressable market, if successful.

Newer therapies like Cobenfy also add optionality to the long-term story, with early launch traction and potential label expansions positioning it as a future growth lever.

The transition is not without challenges. The legacy portfolio — including Eliquis, Revlimid, Pomalyst, Sprycel and Abraxane — still represents 46% of revenues and continues to face significant erosion due to loss of exclusivity for four drugs (Revlimid, Pomalyst, Sprycel and Abraxane).

Story Continues

BMY's Competition in Oncology Space

Oncology is a key therapeutic area of focus for Bristol Myers, which is developing and delivering transformational medicines in this space.

The company competes with big pharma giants like Merck MRK and Pfizer PFE in this space.

The immuno-oncology space is dominated by pharma giant MRK's blockbuster drug Keytruda (pembrolizumab).

Keytruda is approved for several types of cancer and alone accounts for around 55% of MRK's pharmaceutical sales. Merck is currently working on different strategies to drive long-term growth of Keytruda.

Pfizer is one of the largest and most successful drugmakers in the field of oncology. It has an innovative oncology product portfolio of antibody-drug conjugates (ADCs), small molecules, bispecifics and other immune-oncology biologics that treat a wide range of cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer.

Pfizer's position in oncology was strengthened with the addition of Seagen.

The company inked a licensing agreement with 3SBio for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, outside China.

BMY's Price Performance, Valuation & Estimates

Shares of Bristol Myers have gained 5.5% year to date against the industry's decline of 3.9%.Zacks Investment Research

Image Source: Zacks Investment Research

From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, shares currently trade at 9.17x forward earnings, higher than its mean of 8.59x but lower than the large-cap pharma industry's 17.67x.Zacks Investment Research

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 EPS has moved north to $6.32 from $6.29 in the past 60 days, while that for 2027 has moved south to $6.05 from $6.09 in the same time frame.Zacks Investment Research

Image Source: Zacks Investment Research

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

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report

Pfizer Inc. (PFE) : Free Stock Analysis Report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

The recommendations of Wall Street analysts are often relied on by investors when deciding whether to buy, sell, or hold a stock. Media reports about these brokerage-firm-employed (or sell-side) analysts changing their ratings often affect a stock's price. Do they really matter, though?

Before we discuss the reliability of brokerage recommendations and how to use them to your advantage, let's see what these Wall Street heavyweights think about Merck (MRK).

Merck currently has an average brokerage recommendation (ABR) of 1.73, on a scale of 1 to 5 (Strong Buy to Strong Sell), calculated based on the actual recommendations (Buy, Hold, Sell, etc.) made by 30 brokerage firms. An ABR of 1.73 approximates between Strong Buy and Buy.

Of the 30 recommendations that derive the current ABR, 18 are Strong Buy and two are Buy. Strong Buy and Buy respectively account for 60% and 6.7% of all recommendations.

Brokerage Recommendation Trends for MRKBroker Rating Breakdown Chart for MRK

Check price target & stock forecast for Merck here>>>

The ABR suggests buying Merck, but making an investment decision solely on the basis of this information might not be a good idea. According to several studies, brokerage recommendations have little to no success guiding investors to choose stocks with the most potential for price appreciation.

Are you wondering why? The vested interest of brokerage firms in a stock they cover often results in a strong positive bias of their analysts in rating it. Our research shows that for every "Strong Sell" recommendation, brokerage firms assign five "Strong Buy" recommendations.

This means that the interests of these institutions are not always aligned with those of retail investors, giving little insight into the direction of a stock's future price movement. It would therefore be best to use this information to validate your own analysis or a tool that has proven to be highly effective at predicting stock price movements.

Zacks Rank, our proprietary stock rating tool with an impressive externally audited track record, categorizes stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), and is an effective indicator of a stock's price performance in the near future. Therefore, using the ABR to validate the Zacks Rank could be an efficient way of making a profitable investment decision.

Zacks Rank Should Not Be Confused With ABR

Although both Zacks Rank and ABR are displayed in a range of 1--5, they are different measures altogether.

The ABR is calculated solely based on brokerage recommendations and is typically displayed with decimals (example: 1.28). In contrast, the Zacks Rank is a quantitative model allowing investors to harness the power of earnings estimate revisions. It is displayed in whole numbers -- 1 to 5.

Story Continues

It has been and continues to be the case that analysts employed by brokerage firms are overly optimistic with their recommendations. Because of their employers' vested interests, these analysts issue more favorable ratings than their research would support, misguiding investors far more often than helping them.

In contrast, the Zacks Rank is driven by earnings estimate revisions. And near-term stock price movements are strongly correlated with trends in earnings estimate revisions, according to empirical research.

In addition, the different Zacks Rank grades are applied proportionately to all stocks for which brokerage analysts provide current-year earnings estimates. In other words, this tool always maintains a balance among its five ranks.

Another key difference between the ABR and Zacks Rank is freshness. The ABR is not necessarily up-to-date when you look at it. But, since brokerage analysts keep revising their earnings estimates to account for a company's changing business trends, and their actions get reflected in the Zacks Rank quickly enough, it is always timely in indicating future price movements.

Is MRK Worth Investing In?

In terms of earnings estimate revisions for Merck, the Zacks Consensus Estimate for the current year has remained unchanged over the past month at $5.17.

Analysts' steady views regarding the company's earnings prospects, as indicated by an unchanged consensus estimate, could be a legitimate reason for the stock to perform in line with the broader market in the near term.

The size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #3 (Hold) for Merck. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>

It may therefore be prudent to be a little cautious with the Buy-equivalent ABR for Merck.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Phibro Animal Health Corporation PAHC is drawing investor attention because its growth story is increasingly tied to Animal Health, the company’s largest and most strategically important business. The segment now anchors the revenue base, while vaccines, medicated feed additives (MFA) and nutritional specialties give Phibro multiple avenues for expansion.

The stock’s near-term setup depends on whether this segment can keep offsetting risks from regulation, currency swings and uneven demand in smaller businesses.

Here’s a look at Phibro’s stock performance over the past 12 months.Zacks Investment Research

Image Source: Zacks Investment Research

PAHC’s Growth Engine Inside Animal Health

Animal Health accounted for 74% of Phibro’s total revenues in fiscal 2025, making it the company’s clear growth engine. The segment grew 36% from fiscal 2024, reflecting the strength of a broader product platform across MFAs, nutritional specialty products and vaccines. The company develops, manufactures and markets more than 550 product presentations in this business, giving it a wide base of customers and species exposure.

For investors, the focus is simple. If Animal Health continues to grow, it can help Phibro absorb volatility in Mineral Nutrition and Performance Products while supporting a higher-quality earnings base.

Phibro’s MFA Franchise Gets a Bigger Runway

Phibro’s MFA franchise remains central to the Animal Health story, with its leading Stafac/V-Max/Eskalin platform is approved in more than 30 countries. The integration of Zoetis Inc.’s ZTS MFA business has brought more than 37 established product lines marketed across approximately 80 countries, along with six manufacturing sites in the United States, Italy and China.

That broader footprint expands Phibro’s ability to serve customers across regions and supports a larger recurring revenue base. This added scale is important because it does not rely on a single product or geography.

PAHC’s Q3 Segment Mix Shows the Momentum

The fiscal third-quarter 2026 results showed how that platform is translating into revenue momentum. Animal Health net sales increased 13% year over year to $291.2 million, ahead of the internal model projection of $265.7 million.

The acquired MFA business generated a full quarter of revenues and grew 25% over the prior-year period. Legacy MFA sales increased 5%, helped by demand in North America and certain antimicrobials sold by the Ethanol Performance business. Nutritional specialty product sales rose 8% on higher North America demand and higher companion animal sales.

Vaccines net sales were up 16% year over year. That segment mix supported management’s updated fiscal 2026 outlook, including net sales of $1.46 billion to $1.50 billion and adjusted EBITDA of $247 million to $255 million.

Story Continues

Phibro’s Vaccines Add a Differentiated Growth Vector

Phibro’s vaccine business gives Animal Health a growth avenue that differs from mature feed additive categories. In fiscal third-quarter 2026, vaccine sales rose 16%, driven by higher international demand, including Israel, along with stronger domestic swine demand and increased sales of autogenous vaccines.

The business includes approximately 50 product lines for poultry disease prevention, covering areas such as Infectious Bursal Disease, Infectious Bronchitis, Newcastle Disease, Reovirus, Salmonella and Coryza. As disease pressures shift, vaccines can become a more differentiated part of the portfolio because they are less exposed to generic competition than some feed additive categories.

Phibro is also investing in vaccine manufacturing capacity, including its production facility in Guarulhos, Brazil. That capacity expansion supports volume growth and broader access across geographies.

PAHC’s Global Footprint Helps Smooth Species Cycles

Phibro’s international reach adds another layer to the Animal Health case. The company markets nearly 770 product lines in more than 80 countries to about 4,000 customers, with operations focused on regions where livestock production is concentrated in large commercial farms.

That strategy supports product adoption and recurring demand. In fiscal third-quarter 2026, net sales rose 14% year over year in Europe, the Middle East and Africa, 9% in Asia Pacific, and 7% in Latin America and Canada.

Take a look at Phibro’s valuation.Zacks Investment Research

Image Source: Zacks Investment Research

Large peers such as Zoetis and Merck & Co., Inc. MRK also show how broad animal health platforms can benefit from scale, product depth and geographic reach, though Phibro’s mix remains more concentrated around its own feed additive, vaccine and nutrition strengths.

Phibro’s Outlook Balances Tailwinds With Known Risks

Phibro’s Health growth is being supported by the Zoetis MFA portfolio, steady legacy demand and higher vaccine volumes. Management also raised the low end of full-year expectations, a sign that recent execution has improved visibility. Yet, Brazil’s antimicrobial transition creates uncertainty for virginiamycin and bacitracin, while Mecadox remains under regulatory and legal scrutiny. Foreign exchange can also add earnings volatility, with fiscal third-quarter results including $1.9 million of foreign currency losses. Competition is another factor.

PAHC carries a Zacks Rank #2 (Buy), but the path is likely to remain uneven if Brazil disruption, currency pressure or generic competition weigh on the Animal Health growth engine.

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

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Zoetis Inc. (ZTS) : Free Stock Analysis Report

Phibro Animal Health Corporation (PAHC) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE.

Merck Animal Health has agreed to acquire TARGAN, a biodevice company focused on poultry solutions. The deal adds automated, technology driven tools aimed at the poultry sector to Merck's animal health offering. This marks a further step for Merck into animal health technologies alongside its human medicines business.

Merck (NYSE:MRK) is drawing fresh attention after its animal health unit moved to acquire TARGAN, a poultry focused biodevice developer. With the share price at $120.76 and a value score of 3, investors may view this as additional context when considering Merck, including its recent 13.4% year to date return and 53.0% return over the past year.

For shareholders, the TARGAN deal indicates an effort to build more depth in animal health and agriculture technology, areas that operate alongside Merck's established human pharmaceuticals business. Future updates on how TARGAN's technologies are integrated and commercialized within Merck Animal Health will help clarify what this development could mean for Merck's broader portfolio and competitive position in animal health solutions.

Wall Street's queuing for one rocket. While SpaceX counts down to its IPO, other companies tied to the new space race are already in orbit. → 20 Compelling Space Companies watchlist · Global Space Race Investing Ideas screener · Scan the sector by valuation on Rocket Lab's valuation page.NYSE:MRK Earnings & Revenue Growth as at Jun 2026

📰 Beyond the headline: 4 risks and 2 things going right for Merck that every investor should see.

Quick Assessment

⚖️ Price vs Analyst Target: At US$120.76 versus a consensus target of US$129.74, the stock sits about 7% below analyst expectations, which is inside the 10% buffer zone. ✅ Simply Wall St Valuation: Shares are flagged as trading about 47.2% below an estimated fair value, so this news lands while the stock screens as undervalued. ✅ Recent Momentum: A 30 day return of 7.5% shows the market has been pricing in more optimism recently.

There's only one way to know the right time to buy, sell or hold Merck. Head to Simply Wall St's company report for the latest analysis of Merck's Fair Value.

Key Considerations

📊 The TARGAN acquisition expands Merck Animal Health into poultry biodevices, which could make the animal health segment a more meaningful part of the overall story. 📊 Watch for updates on deal closing, integration costs, and any disclosures on revenue contribution from TARGAN over time. ⚠️ Merck already carries a high level of debt and has profit margins of 13.6% versus 27.3% last year, so investors may want to see that any extra spending linked to this deal is carefully managed.

Story Continues

Dig Deeper

For the full picture including more risks and rewards, check out the complete Merck analysis. Alternatively, you can check out the community page for Merck to see how other investors believe this latest news will impact the company's narrative.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Companies discussed in this article include MRK.

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Gilead Sciences Inc. (NASDAQ:GILD) is one of the top large cap value stocks to buy now. On June 8, Gilead Sciences and Merck announced positive topline results from two Phase 3 clinical trials, ISLEND-1 and ISLEND-2, evaluating their investigational once-weekly oral HIV treatment. The regimen, which combines islatravir and lenacapavir, successfully met its primary efficacy endpoint at Week 48 in both studies, showing statistical non-inferiority when compared to daily standard-of-care antiretroviral therapies.

This novel combination uses two distinct mechanisms of action: islatravir, a next-generation nucleoside analog, and lenacapavir, a first-in-class capsid inhibitor that disrupts the HIV lifecycle at multiple stages. The companies reported that the safety profile of the once-weekly tablet was generally comparable to existing treatments, with no new safety concerns identified throughout the trials.Is Gilead (GILD) One of the Top Large Cap Value Stocks to Buy Now?

If approved, the regimen would become the first long-acting oral HIV treatment taken only once per week, offering patients increased flexibility and discretion. Gilead Sciences Inc. (NASDAQ:GILD) and Merck plan to submit these Phase 3 findings to global regulatory authorities and present detailed data at an upcoming scientific congress to further support the development of this potential new standard of care.

Gilead Sciences Inc. (NASDAQ:GILD) is a drug manufacturer that develops medicines for unmet medical needs. The company provides treatments for HIV-1, chronic hepatitis C, primary biliary cholangitis, chronic hepatitis B, and serious invasive fungal infections. It also offers T-cell and CAR T-cell therapies for adult patients, intravenous injections, and treatments for COVID-19.

While we acknowledge the potential of GILD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 33 Stocks That Should Double in 3 Years and Cathie Wood 2026 Portfolio: 10 Best Stocks to Buy.

Disclosure: None. Follow Insider Monkey on Google News.

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Mergers and acquisitions (M&A) activity across pharmaceutical and biotech sectors has accelerated significantly in 2026, extending the strong recovery that began in 2025.

A recent surge in dealmaking underscores the industry's focus on portfolio expansion and continuous pipeline innovation, alongside a growing emphasis on AI-driven drug discovery. Oncology and immuno-oncology companies have always been at the top of acquisition targets. Major players are actively pursuing licensing agreements and collaborations around promising drugs and candidates to further strengthen and diversify their core portfolios.

Quick Take on Recent M&A Deals

Pharma conglomerate Johnson & Johnson recently announced that it will acquire Firefly Bio for $1 billion and gain access to its Firelink degrader antibody conjugate platform. The deal strengthens Johnson & Johnson's oncology pipeline by adding a targeted approach for KRAS-driven cancers, supporting its efforts to develop treatments for some of the most common and challenging solid tumors.

Other pharma giants Eli Lilly LLY and Novartis NVS have been on an acquisition spree this year.

Lilly recently announced agreements to acquire Curevo, LimmaTech Biologics, and Vaccine Company, expanding its infectious disease research and development capabilities.

Lilly has been actively expanding its pipeline through acquisitions. LLY is all set to acquire Ajax Therapeutics, which will add AJ1-11095, a potential first-in-class oral type II JAK2 inhibitor currently in phase I testing for myelofibrosis patients previously treated with type I JAK2 inhibitors, to its pipeline.  The company also announced a deal to acquire clinical-stage biotechnology company Kelonia Therapeutics, Inc, a pioneer in vivo gene delivery.

The company had earlier agreed to acquire Centessa Pharmaceuticals for up to $7.8 billion, which will add orexin-based sleep disorder candidate cleminorexton to its pipeline. Lilly also struck a deal worth up to $2.4 billion for Orna Therapeutics, to gain access to its circular RNA-based immune cell engineering platform. Lilly also acquired Ventyx Biosciences to strengthen its portfolio of oral therapies targeting inflammatory diseases.

Swiss pharma bigwig Novartis, too, has been very active on the M&A front.  NVS is set to acquire Excellergy Inc., strengthening its immunology pipeline with a focus on food allergies and other IgE-mediated conditions. The deal brings in EXL-111, a phase I, half-life-extended anti-IgE antibody.

Earlier this year, Novartis acquired Avidity Biosciences, adding its antibody oligonucleotide conjugate (AOC) platform and three late-stage programs, further bolstering its neuromuscular pipeline.

Story Continues

Last month, Merck MRK acquired Terns Pharmaceuticals for $53 per share in cash. The deal adds TERN-701, a potential best-in-class treatment for chronic myeloid leukemia that recently received FDA Breakthrough Therapy Designation. The acquisition strengthens Merck's oncology pipeline.

Among biotech giants, Gilead Sciences, Inc. GILD is ramping up its external innovation strategy through targeted acquisitions to strengthen its pipeline and reduce reliance on its core HIV franchise.

Gilead and partner Lakefront Biotherapeutics (formerly known as Galapagos) recently acquired Ouro Medicines, adding gamgertamig, a clinical-stage BCMAxCD3 T-cell engager, to strengthen their autoimmune disease and inflammation pipeline.

Last month, Gilead acquired Tubulis, a clinical-stage biotech focused on developing next-generation antibody-drug conjugates (ADCs), strengthening its oncology pipeline.

Earlier this year, GILD acquired Arcellx for about $7.8 billion. The acquisition gives Gilead full ownership of anito-cel, an investigational late-stage CAR-T therapy for multiple myeloma with a potential U.S. decision by December 2026.

Another biotech giant Biogen recently acquired Apellis Pharmaceuticals $41 per share in cash plus contingent value rights worth up to an additional $4 per share tied to future sales milestones. The acquisition adds two commercialized therapies, Empaveli and Syfovre, to Biogen's portfolio. Together, the drugs generated $689 million in sales in 2025. The transaction strengthens Biogen's presence in immunology and rare diseases while establishing a foothold in nephrology.

Earlier this week, GSK plc GSK announced that it will acquire clinical-stage biopharmaceutical company Nuvalent for $10.6 billion, gaining three lung cancer assets, including late-stage ROS1 inhibitor zidesamtinib and ALK inhibitor neladalkib, both under FDA review. The deal strengthens GSK's oncology pipeline, expands its presence in lung cancer, and is expected to contribute to sales and operating profit growth beginning in 2027.

GSK earlier acquired RAPT Therapeutics to strengthen its immunology pipeline. The company also bought 35Pharma, adding HS235, a potential best-in-class therapy for pulmonary hypertension.

Last week, Servier (an independent international pharmaceutical group governed by a foundation) agreed to acquire the muscular dystrophy business of Edgewise Therapeutics in a deal worth up to $2.65 billion, including $1.55 billion upfront and up to $1.1 billion in milestone payments.

Road Ahead in 2026

Consolidation remains a key theme as companies seek to offset patent cliffs and diversify revenue streams. Acquisitions offer a faster, less risky route than in-house development, especially as innovation cycles shorten.

With strong cash reserves and increasing adoption of advanced technologies like AI, M&A activity is expected to remain robust through 2026. Smaller biotechs, often constrained by funding, will likely remain prime acquisition targets, further fueling deal momentum.

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

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report

Novartis AG (NVS) : Free Stock Analysis Report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Eli Lilly and Company (LLY) : Free Stock Analysis Report

Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

For Immediate Release

Chicago, IL – June 11, 2026 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Merck & Co., Inc. MRK, The Southern Co. SO, Lumentum Holdings Inc. LITE and Peoples Bancorp of North Carolina, Inc. PEBK.

Here are highlights from Wednesday’s Analyst Blog:

Top Research Reports for Merck, Southern Company and Lumentum

The Zacks Research Daily presents the best research output of our analyst team. Today's Research Daily features new research reports on 16 major stocks, including Merck & Co., Inc., The Southern Co. and Lumentum Holdings Inc., as well as a micro-cap stock Peoples Bancorp of North Carolina, Inc.. The Zacks microcap research is unique as our research content on these small and under-the-radar companies is the only research of its type in the country.

These research reports have been hand-picked from the roughly 70 reports published by our analyst team today.

You can see all of today's research reports here >>>

Today's Featured Research Reports

Merck's shares have outperformed the Zacks Large Cap Pharmaceuticals industry over the past year (+53.3% vs. +25.2%). The company's blockbuster drug, Keytruda, and new products have been driving sales. Animal Health is also contributing to growth. Though Keytruda will lose patent exclusivity in 2028, its sales are expected to remain strong until then.

Merck's new products, Winrevair, Welireg and Capvaxive, key pipeline progress and expansion of its respiratory and infectious disease and oncology portfolios through the acquisitions of Verona Pharma, Cidara Therapeutics and Terns Pharmaceuticals have improved its long-term growth prospects. This progress has increased confidence that Merck can maintain growth even after Keytruda loses exclusivity.

However, it faces several near-term challenges, including persistent challenges for Gardasil in China, potential competition for Keytruda, and rising competitive and generic pressure on some of its drugs.

(You can read the full research report on Merck here >>>)

Shares of Southern Company have gained +7.1% over the past year against the Zacks Utility - Electric Power industry's gain of +23.2%. The company is a leading U.S. electric utility with a stable, recession-resistant business model, benefiting from strong electricity demand growth, particularly from data centers and hyperscale customers, and a robust pipeline exceeding 75 gigawatts of potential projects.

Southern Company is expanding its regulated generation and transmission assets, investing in battery storage and renewable projects, and maintaining a 25-year streak of dividend increases, appealing to income-focused investors.

However, elevated leverage with $67.1 billion in long-term debt, capital-intensive infrastructure needs, exposure to economic slowdowns, regulatory risks, ongoing depreciation charges, and weather-driven earnings volatility limit financial flexibility. Hence, investors are advised to wait for a better entry point.

(You can read the full research report on Southern Company here >>>)

Lumentum's shares have outperformed the Zacks Communication - Components industry over the past year (+968.3% vs. +313.6%). The company is benefiting from sustained AI and cloud network buildouts, with record fiscal Q3 revenue and expanding profitability as laser chips and cloud transceivers scale.

Management's Q4 outlook calls for another step up in revenue and operating margin, supported by continued EML growth, scale-across components like pump and narrow linewidth lasers, and a ramp in 1.6T transceivers with initial internal CW laser integration. A multiyear OCS purchase agreement and the acquisition of an additional indium phosphide fab, backed by a larger cash balance, extend capacity and visibility, while CPO development moves toward revenue.

However, supply constraints and outsourcing dependence can delay shipments, and ongoing ASP and customer concentration risks remain a headwind. Industrial lasers remain muted and can dilute the mix.

(You can read the full research report on Lumentum here >>>)

Shares of Peoples Bancorp of North Carolina have outperformed the Zacks Banks - Southeast industry over the past year (+66.1% vs. +15.4%). This microcap company with a market capitalization of $236.97 million has its investment thesis supported by improving earnings power, driven by balance-sheet management, loan growth and a stable deposit franchise. Margin expansion reflects effective asset-liability management and favorable funding dynamics, while loan growth continues to support revenue generation.

Strong capital levels and a conservative dividend policy provide flexibility to support future growth and shareholder returns. However, key risks include rising operating expenses, potential margin compression from higher funding costs and higher credit costs tied to portfolio growth.

Fee income remains sensitive to appraisal-related activity. Valuation reflects investor caution around the sustainability of earnings growth and credit performance. Further upside will depend on sustaining profitability, maintaining credit quality and delivering consistent earnings growth.

(You can read the full research report on Peoples Bancorp of North Carolina here >>>)

Story Continues

Free: Instant Access to Zacks' Market-Crushing Strategies

Since 2000, our top stock-picking strategies have blown away the S&P's +7.7% average gain per year. Amazingly, they soared with average gains of +48.4%, +50.2% and +56.7% per year.

Today you can tap into those powerful strategies – and the high-potential stocks they uncover – free. No strings attached.

Get all the details here >>

Media Contact

Zacks Investment Research

800-767-3771 ext. 9339

support@zacks.com

https://www.zacks.com

Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Southern Company (The) (SO) : Free Stock Analysis Report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Lumentum Holdings Inc. (LITE) : Free Stock Analysis Report

Peoples Bancorp of North Carolina, Inc. (PEBK) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

View Comments

Haftungsausschluss: Der Text wurde mit Hilfe einer KI zusammengefasst und übersetzt. Für Aussagen aus dem Originaltext wird keine Haftung übernommen!

Investors deciding between Lexicon Pharmaceuticals(NASDAQ:LXRX) and Pfizer(NYSE:PFE) face a choice between an emerging high-growth biotech player and an established global pharmaceutical titan with massive scale.

These two companies operate at opposite ends of the size spectrum, with one focusing on specialized precision medicine while the other manages a vast portfolio of vaccines and therapies. This comparison explores their recent financial health and risk profiles.

The case for Lexicon Pharmaceuticals

Lexicon Pharmaceuticals operates as a contender among biotech stocks by utilizing gene science to develop treatments for chronic conditions. The company primarily focuses on its commercial product, INPEFA, while licensing its programs to partners like Viatris for international markets. Specific customer concentration data was not disclosed in recent filings.

In FY 2025, revenue reached nearly $49.8 million, representing approximately 60% growth over the previous year. Despite this improvement, the company reported a net loss of $50.3 million for the period.

As of its December 2025 balance sheet, the debt-to-equity ratio was roughly 0.6x. This ratio compares total debt to shareholder equity, indicating the extent to which a firm relies on borrowed money.

The case for Pfizer

Pfizer is a global biopharmaceutical leader that discovers, manufactures, and distributes medicines and vaccines across approximately 200 countries. With a workforce of nearly 75,000 employees, the company maintains a dominant presence in both developed and emerging markets. Its scale allows it to manage a massive product pipeline simultaneously, though specific major customers are not disclosed in its filings.

During FY 2025, revenue reached approximately $62.6 billion, representing a slight decrease of nearly 1.6% from the prior year. The company reported net income of roughly $7.8 billion. This level of profitability resulted in a net margin of close to 12.4%.

Based on the December 2025 balance sheet, the debt-to-equity ratio was approximately 0.8x. Free cash flow for the fiscal year was approximately $9.1 billion, providing substantial capital for dividends and research.

Risk profile comparison

Lexicon Pharmaceuticals faces significant regulatory risks, particularly regarding the approval process for candidates such as ZYNQUISTA for type 1 diabetes. The company also carries an accumulated deficit of nearly $2.0 billion, which may necessitate additional capital raises on unfavorable terms. Furthermore, a single entity, Artal Group, holds roughly 35% of the shares, limiting the influence of smaller retail shareholders.

Story Continues

Pfizer faces significant revenue concentration, with 12 products accounting for roughly 65% of its total 2025 revenue. The company faces a period of patent expirations between 2026 and 2030, which could lead to significant competition from generic drug makers. Additionally, government pricing regulations and competition from large peers such as Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) could affect long-term profitability.

Valuation comparison

While Lexicon Pharmaceuticals lacks a Forward P/E due to its net losses, Pfizer appears much more affordable based on its P/S ratio.

Metric Lexicon Pharmaceuticals Pfizer Sector Benchmark Forward P/E n/a 8.7x 24.9x P/S ratio 16.8x 2.3x

Sector benchmark uses the SPDR XLV sector ETF. Valuation metrics sourced from Financial Modeling Prep (FMP) and may differ from other data providers.

Which stock would I buy in 2026?

Finding a low-priced, development-stage biotech stock that explodes into a long-term 10-bagger on the success of a treatment that eventually reaches market is a dream for investors. Unfortunately, it usually stays that way: a dream that doesn’t become reality. Development-stage pharma companies often fail to get a blockbuster drug to market.

Lexicon Pharmaceuticals is not exactly development stage. It has one product on the market, INPEFA, for a once-a-day tablet for treating heart failure, but it generated just $1.1 million in sales in the first quarter of 2026. Most of the interest around Lexicon is for developmental drugs for chronic pain and cardiometabolic treatments. There are some positives in the trials, but it’s always worth keeping in mind that positive trials can still fail to bring a drug to market due to late regulatory rejections or a developer’s belief that the drug won’t find much market. Lexicon’s low stock price, which has traded between $1 and $2.50 since July 2025, indicates the speculative nature of the business.

Pfizer isn’t a hot growth stock, but it’s also one of the giants of the pharmaceutical industry. The company had a post-COVID letdown of sorts, as pandemic-related demand ebbed, but the business has been flexing its might this year. In its first quarter, Pfizer beat Wall Street analysts’ expectations on sales and net income. That is partly because Pfizer has been buying growth — it recently acquired oncology specialist Seagen and posted 20% growth in that business’s products. Prifzer is also allocating significant resources to new drug development, with 20 drug development starts scheduled for 2026 and eight data readouts expected, which report on the progress of treatments in development. After falling behind in the GLP-1 weight-loss drug market, Pfizer is also making strides toward becoming a competitor, with very positive Phase II (of III) trial results for an injectable GLP-1 reported earlier this year.

With more than $6 billion in cash, a forward price-to-earnings ratio of a bargain basement 8.7, and a tasty yield of 7% based on its recent price of $26, Pfizer is the choice for 2026.

Should you buy stock in Lexicon Pharmaceuticals right now?

Before you buy stock inLexicon Pharmaceuticals, consider this:

The Motley FoolStock Advisoranalyst team just identified what they believe are the 10 best stocksfor investors to buy now… andLexicon Pharmaceuticalswasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years.

Consider whenNetflixmade this list on December 17, 2004... if you invested $1,000 at the time of our recommendation,you’d have $442,220! Or when Nvidiamade this list on April 15, 2005... if you invested $1,000 at the time of our recommendation,you’d have $1,230,114!

That performance is why people listen. With a track record ofbeating the S&P 500 by nearly 5x,Stock Advisoroffers a distinct advantage. Don't miss the latest top 10 list, available withStock Advisor, and join an investing community built for the long haul.

See the 10 stocks »

*Stock Advisor returns as of June 11, 2026.

Brendan Coffey has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Eli Lilly, Merck, and Pfizer. The Motley Fool has a disclosure policy.

Lexicon Pharmaceuticals vs. Pfizer: Which Drugmaker Stock Is a Better Buy in 2026? was originally published by The Motley Fool

View Comments