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Cardinal Capital Management lifted its stake in shares of Merck & Co., Inc. (NYSE:MRK – Free Report) by 3.6% during the 3rd quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission (SEC). The firm owned 99,742 shares of the company’s stock after acquiring an additional 3,507 shares during the period. Merck & Co., Inc. accounts for about 1.7% of Cardinal Capital Management’s investment portfolio, making the stock its 13th largest position. Cardinal Capital Management’s holdings in Merck & Co., Inc. were worth $14,578,000 as of its most recent filing with the Securities and Exchange Commission (SEC).

Other hedge funds have also modified their holdings of the company. Round Rock Advisors LLC increased its position in Merck & Co., Inc. by 0.7% during the second quarter. Round Rock Advisors LLC now owns 9,901 shares of the company’s stock worth $1,272,000 after purchasing an additional 66 shares during the last quarter. Cascade Financial Partners LLC boosted its holdings in shares of Merck & Co., Inc. by 0.5% in the 2nd quarter. Cascade Financial Partners LLC now owns 14,746 shares of the company’s stock valued at $1,895,000 after purchasing an additional 80 shares during the last quarter. Somerset Trust Co boosted its holdings in shares of Merck & Co., Inc. by 0.9% in the 2nd quarter. Somerset Trust Co now owns 8,701 shares of the company’s stock valued at $1,118,000 after purchasing an additional 81 shares during the last quarter. Stonebridge Financial Group LLC grew its stake in shares of Merck & Co., Inc. by 0.9% during the 2nd quarter. Stonebridge Financial Group LLC now owns 8,747 shares of the company’s stock valued at $1,124,000 after buying an additional 81 shares during the period. Finally, Stronghold Wealth Management L.L.C. grew its stake in shares of Merck & Co., Inc. by 2.6% during the 2nd quarter. Stronghold Wealth Management L.L.C. now owns 3,237 shares of the company’s stock valued at $416,000 after buying an additional 82 shares during the period. 76.07% of the stock is owned by institutional investors and hedge funds.

Analyst Ratings Changes A number of research firms have recently commented on MRK. Zacks Research downgraded Merck & Co., Inc. from a “hold” rating to a “strong sell” rating in a report on Monday. Daiwa Securities Group upgraded Merck & Co., Inc. from a “neutral” rating to an “outperform” rating and set a $143.00 price target for the company in a research note on Wednesday, August 12th. UBS Group raised their price objective on Merck & Co., Inc. from $145.00 to $175.00 and gave the stock a “buy” rating in a report on Thursday, August 20th. BMO Capital Markets lifted their price objective on Merck & Co., Inc. from $142.00 to $170.00 and gave the company an “outperform” rating in a research note on Thursday, August 20th. Finally, CICC Research started coverage on Merck & Co., Inc. in a research note on Wednesday, June 24th. They issued an “outperform” rating and a $138.00 price objective on the stock. Seventeen research analysts have rated the stock with a Buy rating, nine have assigned a Hold rating and one has given a Sell rating to the stock. According to data from MarketBeat.com, the stock presently has an average rating of “Moderate Buy” and a consensus price target of $151.92.

Check Out Our Latest Research Report on Merck & Co., Inc. Merck & Co., Inc. Stock Performance Merck & Co., Inc. stock opened at $149.98 on Thursday. The firm has a market capitalization of $370.02 billion, a PE ratio of 119.98, a price-to-earnings-growth ratio of 6.85 and a beta of 0.21. Merck & Co., Inc. has a one year low of $82.01 and a one year high of $156.92. The stock’s 50 day moving average price is $146.55 and its 200 day moving average price is $129.88. The company has a debt-to-equity ratio of 1.22, a quick ratio of 1.10 and a current ratio of 1.32.

Merck & Co., Inc. (NYSE:MRK – Get Free Report) last issued its quarterly earnings data on Tuesday, August 4th. The company reported ($0.13) earnings per share (EPS) for the quarter, beating the consensus estimate of ($0.26) by $0.13. Merck & Co., Inc. had a net margin of 4.77% and a return on equity of 16.73%. The company had revenue of $16.61 billion during the quarter, compared to the consensus estimate of $16.37 billion. During the same quarter last year, the company earned $2.13 earnings per share. Merck & Co., Inc.’s revenue for the quarter was up 5.1% on a year-over-year basis. Merck & Co., Inc. has set its FY 2026 guidance at 2.660-2.760 EPS. As a group, sell-side analysts expect that Merck & Co., Inc. will post 2.66 EPS for the current fiscal year.

Merck & Co., Inc. Dividend Announcement The company also recently declared a quarterly dividend, which was paid on Wednesday, October 7th. Investors of record on Tuesday, September 15th were paid a dividend of $0.85 per share. The ex-dividend date of this dividend was Tuesday, September 15th. This represents a $3.40 annualized dividend and a yield of 2.3%. Merck & Co., Inc.’s payout ratio is 272.00%.

Merck & Co., Inc. News Summary Here are the key news stories impacting Merck & Co., Inc. this week:

Positive Sentiment: The European Commission approved KEYTRUDA plus Padcev as perioperative treatment for adults with resectable muscle-invasive bladder cancer. The expanded indication strengthens Merck’s oncology portfolio, supports additional long-term revenue opportunities and reinforces the commercial value of the two-drug combination. European Commission KEYTRUDA and Padcev approval Positive Sentiment: The latest trading session saw Merck outperform the broader market, reflecting investor interest in its strong oncology franchise and recent product catalysts. Merck outperforms the stock market Neutral Sentiment: Merck’s participation in the growing bioconjugation and cell-culture-media markets provides potential exposure to expanding biopharmaceutical research demand, but the reports offer no specific financial impact or new company guidance. Bioconjugation market report Cell culture media market report Neutral Sentiment: Reports on Merck’s phase 3 melanoma results and ETF selling could influence sentiment, but the available information does not provide enough detail to assess the magnitude or durability of either development. Merck phase 3 melanoma results Negative Sentiment: Zacks Research downgraded Merck from “hold” to “strong sell,” adding selling pressure and highlighting valuation or growth concerns. Negative Sentiment: KEYTRUDA and KEYTRUDA QLEX remain Merck’s primary earnings engine, while U.S. growth is expected to moderate as the drug approaches peak penetration. The looming patent cliff and a legal setback affecting subcutaneous KEYTRUDA sales in several European markets increase concerns about Merck’s ability to replace future lost revenue with newer treatments. Merck KEYTRUDA growth and patent cliff analysis Insider Transactions at Merck & Co., Inc. In other news, EVP Jennifer Zachary sold 80,315 shares of Merck & Co., Inc. stock in a transaction dated Wednesday, August 12th. The stock was sold at an average price of $133.46, for a total transaction of $10,718,839.90. Following the sale, the executive vice president directly owned 45,509 shares of the company’s stock, valued at approximately $6,073,631.14. The trade was a 63.83% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which can be accessed through this hyperlink. Also, EVP Chirfi Guindo sold 15,000 shares of the business’s stock in a transaction dated Thursday, August 6th. The stock was sold at an average price of $131.00, for a total value of $1,965,000.00. Following the completion of the transaction, the executive vice president owned 46,613 shares in the company, valued at approximately $6,106,303. This trade represents a 24.35% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. Insiders have sold a total of 228,238 shares of company stock worth $29,977,783 over the last three months. Insiders own 0.17% of the company’s stock.

Merck & Co., Inc. Profile (Free Report)

Merck & Co, Inc is a global healthcare company that develops, manufactures and markets prescription medicines, vaccines and animal-health products. Its pharmaceutical business focuses on oncology, infectious diseases, cardiology, immunology and other areas of significant medical need. The company serves patients, healthcare providers and institutions in markets worldwide.

Merck’s principal products include Keytruda, an immunotherapy used to treat a range of cancers; Gardasil and Gardasil 9, vaccines that help protect against human papillomavirus; and Januvia and Janumet, medicines used to manage type 2 diabetes.

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Key Takeaways Merck's Keytruda generated $16.40 billion in first-half 2026 sales, up 4.2% year over year.Keytruda Q3 sales could benefit from strong metastatic demand, earlier-stage launches and label expansions.Merck targets $35 billion in peak Keytruda sales by 2028, before biosimilars threaten future growth. Merck’s (MRK - Free Report) revenues are primarily derived from the oncology portfolio, led by its blockbuster PD-L1 inhibitor, Keytruda. The drug accounts for more than 55% of the company’s pharmaceutical sales.

Keytruda generated $16.40 billion in sales in the first six months of 2026, increasing 4.2% year over year. Keytruda Qlex, the subcutaneous formulation of Keytruda, contributed $590 million during this period. Keytruda Qlex can offer substantially quicker administration time than the intravenous infusion of Keytruda.

Building on this growing momentum, we expect investors to keep a close eye on Keytruda's sales performance when Merck reports its third-quarter 2026 results on Oct. 29.

Keytruda sales are likely to have gained from continued strong momentum in metastatic indications and rapid uptake across earlier-stage launches during the third quarter. Recent label expansions, including Keytruda’s use in combination with Pfizer’s Padcev in muscle-invasive bladder cancer, have broadened its patient base and should also support sales growth.

The Zacks Consensus Estimate for Keytruda’s third-quarter sales stands at $7.45 billion.

Importantly, the company expects Keytruda’s strong growth to continue until the drug loses patent exclusivity in 2028. Management expects the drug to achieve peak sales of $35 billion by 2028 before it loses exclusivity.

However, Keytruda is expected to face significant biosimilar competition around 2028-2029. Once biosimilars enter, Keytruda’s sales are likely to decline sharply.

PD-L1 Inhibitors Competing With MRK's KeytrudaKeytruda faces competition from other PD-L1 inhibitors, including Bristol Myers’ (BMY - Free Report) Opdivo, Roche’s (RHHBY - Free Report) Tecentriq and AstraZeneca’s (AZN - Free Report) Imfinzi.

BMY’s Opdivo, like Keytruda, is approved across multiple cancer types, including lung, melanoma and kidney cancers. Bristol Myers recorded $4.63 billion in Opdivo sales in the first half of 2026, down 3.9% year over year.

Tecentriq is Roche’s leading immuno-oncology drug approved for multiple cancer indications. RHHBY recorded CHF 1.70 billion in Tecentriq sales in the first half of 2026, up 6% year over year.

AZN’s Imfinzi generated sales of $3.55 billion in the first half of 2026, up 29%, driven by strong demand growth across all regions from established indications and new launches. Imfinzi has strategically expanded its use across multiple cancer indications, strengthening AstraZeneca’s oncology portfolio.

MRK's Price Performance, Valuation and EstimatesYear to date, shares of Merck have rallied 37.7% compared with the industry’s 15.1% rise. The stock has also outperformed the sector and the S&P 500 during the same time frame, as seen in the chart below.

Image Source: Zacks Investment Research

From a valuation standpoint, Merck appears to be trading at a discount compared to the industry. Going by the price/earnings ratio, MRK’s shares currently trade at 17.94 forward earnings, lower than 18.33 for the industry. The stock is trading above its 5-year mean of 13.04.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 earnings per share has declined from $2.78 to $2.66, while the same for 2027 has declined from $9.67 to $9.27 over the past 60 days.

Image Source: Zacks Investment Research

MRK's Zacks RankMerck currently has a Zacks Rank #4 (Sell).

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

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of one-year results from the pivotal Phase 2b/3 BRUNELLO trial evaluating remigromig (MK-3000, formerly EYE103), an investigational, potentially first-in-class tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, for the treatment of diabetic macular edema (DME). Results were presented today at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans: BRUNELLO - 1-Year Pivotal Trial Results of Remigromig (MK-3000, formerly EYE103) for the Treatment of Diabetic Macular Edema; D. D'Amico.

In the BRUNELLO study, both remigromig dose arms met the primary endpoint independently, demonstrating non-inferiority in mean change from baseline in best corrected visual acuity (BCVA) at one year compared with monthly 0.5mg ranibizumab. Mean BCVA gains at Year 1 were +9.1 letters (95% CI, 8.1-10.1; p=0.0129, multiplicity-adjusted) with remigromig 0.5 mg and +8.7 letters (95% CI, 7.7-9.8; p=0.0222, multiplicity-adjusted) with remigromig 0.8 mg, compared with +11.8 letters with ranibizumab (95% CI, 10.7-12.8). Differences between treatment groups were within the prespecified non-inferiority margin and were not considered clinically meaningful. No secondary endpoints demonstrated superiority to ranibizumab.

While both doses of remigromig were generally well tolerated, adverse events related to proliferative diabetic retinopathy (PDR) occurred more frequently with remigromig than with ranibizumab (6.7% and 6.1% with remigromig 0.5 mg and 0.8 mg, respectively, versus 0.9%), inclusive of new-onset PDR.1 In addition, higher rates of treatment discontinuations due to adverse events were observed in the remigromig treatment arms compared with ranibizumab (4.9% and 4.5% with remigromig 0.5 mg and 0.8 mg, respectively, versus 0.9%). Additional analyses are underway to further characterize these findings. PDR rates may reflect natural disease progression in DME patients since remigromig focuses on repair and maintenance of the blood-retinal barrier rather than directly suppressing new vessel growth. PDR cases were generally manageable with standard-of-care treatment.

“Although anti-VEGF therapies remain the foundation of treatment for diabetic macular edema, up to two thirds of patients fail to achieve clinically meaningful vision gains after one year, underscoring the need to explore new biological pathways,” said Donald J. D’Amico, M.D., chair of Ophthalmology at Weill Cornell Medicine, Ophthalmologist-in-Chief, New York-Presbyterian Hospital and presenting author of the BRUNELLO study. “These findings ‒ which demonstrate for the first time that a biologic targeting the Wnt pathway can achieve visual acuity comparable to an established anti-VEGF therapy ‒ support continued evaluation of this novel approach as we look forward to additional Phase 3 results from the BAROLO study.”

“Despite important advances in care, up to 40% of patients with diabetic macular edema have persistent disease activity after six months of treatment, meaning that they do not respond or only partially respond to therapy, underscoring the need for new therapeutic approaches,” said Dr. David Guyer, founder, chief executive officer and president of EyeBio, a wholly owned subsidiary of Merck. “The BRUNELLO study provides important evidence that activating the Wnt pathway, which is involved in the repair and maintenance of the blood-retinal barrier, may offer a potential new way to help patients with DME and expand treatment options for retinal specialists and their patients.”

“The BRUNELLO results represent an important milestone for people living with diabetic macular edema, a leading cause of vision loss among people living with diabetes, which impacts nearly 1.6 million people in the U.S.,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “As the first new mechanism of action in more than 20 years to demonstrate non-inferior visual acuity compared with standard-of-care anti-VEGF therapy in a pivotal DME study, remigromig has the potential to expand treatment options for retinal specialists and patients. We thank the patients, caregivers and investigators whose participation made this study possible.”

The BRUNELLO trial data further strengthens Merck’s advancing ophthalmology pipeline, which is aimed at promoting retinal recovery by addressing specific retinal diseases associated with vascular leakage and neovascularization, including DME, neovascular (wet) age-related macular degeneration (NVAMD) and macular edema secondary to retinal vein occlusion (RVO).

Results from BRUNELLO will be discussed with regulatory authorities. Remigromig is also being evaluated in the ongoing pivotal Phase 2b/3 BAROLO study (NCT06957080) in patients with DME and in a Phase 2 proof-of-concept study (SUPER TUSCAN) in patients with NVAMD and RVO (NCT07205887).

The company is also developing MK-8748 (also known as Tiespectus, EYE201), a novel investigational bispecific antibody with a dual mechanism that directly activates the Tie2 pathway and inhibits VEGF with the goal of stabilizing retinal and choroidal blood vessels and reducing fluid accumulation in the macula. MK-8748 is currently being studied in two pivotal Phase 2b/3 trials for the treatment of NVAMD, TORRONTES (NCT07496567) and MALBEC (NCT07440225), and in two pivotal Phase 3 studies for the treatment of DME, SANGIOVESE (NCT07705555) and SYRAH (NCT07705607).

About the BRUNELLO trial

BRUNELLO is a randomized, double masked pivotal Phase 2b/3 trial (NCT06571045) evaluating the safety and efficacy of two dose levels (0.5 mg and 0.8 mg) of intravitreal (IVT) remigromig (MK-3000, formerly EYE103) versus active control 0.5mg ranibizumab in adults with DME. The trial enrolled 984 participants who were randomized 1:1:1 to receive low and high dose regimens of remigromig or ranibizumab every four weeks for the first year. In the second year, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. The primary endpoint is mean change in best-corrected visual acuity (BCVA) from baseline to week 52 in the study eye of the participants, using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) vision testing. The key secondary endpoints at week 52 are mean change from baseline in BCVA (superiority of remigromig vs. ranibizumab), and mean change from baseline in Central Subfield Thickness (CST) (superiority of remigromig vs. ranibizumab).

About Remigromig

Remigromig (MK-3000, formerly EYE103) is an investigational, potentially first-in-class tetravalent, tri-specific antibody designed to activate the Wingless-related integration site (Wnt) pathway, which is involved in the repair and maintenance of the blood-retinal-barrier. Remigromig is being studied in patients with certain retinal diseases including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Remigromig is administered by intravitreal injection.

About diabetic macular edema

Diabetic macular edema (DME) is a serious retinal condition and a leading cause of vision loss for people with diabetes. An estimated 1.6 million people are living with DME in the United States. DME occurs when damaged blood vessels leak into the retina, resulting in swelling in the macula, the central region of the retina crucial for precise vision necessary for everyday activities. The prevalence of DME is anticipated to rise with the increasing incidence of diabetes. While currently available treatments have helped to improve outcomes, a significant number of patients, up to 40%, do not respond or only partially respond to therapy, underscoring the need for new treatment approaches.

About Merck

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

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

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

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

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

1 PTs indicative of PDR: diabetic retinopathy (if LLT ‘proliferative diabetic retinopathy’), vitreous hemorrhage, iris neovascularization, retinal neovascularization, glaucoma (if LLT ‘neovascular glaucoma’), neovascularization

View source version on businesswire.com: https://www.businesswire.com/news/home/20261010000066/en/

Key Takeaways Halozyme won a Dutch ruling finding Keytruda SC infringes an MDASE patent.Merck must stop making and selling Keytruda SC across eight European markets.Halozyme's ENHANZE business remains separate and supports royalties from 10 commercialized products. Halozyme Therapeutics (HALO - Free Report) announced that a Dutch patent court has issued a ruling in its favor in a patent dispute with Merck (MRK - Free Report) over Keytruda’s subcutaneous (SC) formulation.

The court found that Merck’s Keytruda SC infringes one of Halozyme’s MDASE patents, which covers technology used to deliver drugs through SC injection. The ruling orders Merck to stop manufacturing and selling Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. It also prevents Merck from allowing its affiliates to continue selling the drug in these markets, including through the use of its European marketing authorization.

However, the court order does not affect the intravenous (IV) version of Keytruda. Patients will continue to have access to Keytruda IV because it is not covered by Halozyme’s patent or the court’s injunction.

This is not the first legal victory Halozyme has secured against Merck over Keytruda SC. In December 2025, a German court granted Halozyme a preliminary injunction that stopped Merck from distributing or offering Keytruda SC in Germany. HALO has also filed a separate patent infringement lawsuit against MRK in the United States, alleging that Keytruda SC, marketed as Keytruda Qlex, infringes 15 of its MDASE patents.

MRK Seeks to Fight the RulingMerck strongly disagrees with the Dutch court’s decision, according to Reuters. It considers Halozyme’s patent to be invalid globally and said its infringement allegation is without merit. Merck is evaluating its next steps.

The ruling is nevertheless an important setback for Merck as it seeks to expand the use of Keytruda. The SC version is intended to help extend Keytruda’s commercial opportunity as Merck approaches the loss of U.S. patent protection for the original formulation, with biosimilar competition potentially beginning in December 2028. Currently, the IV and SC versions together generate nearly half of Merck’s topline, making Keytruda an important part of the company’s strategy to preserve and extend the franchise.

For Halozyme, the widening restrictions on Keytruda SC could provide greater leverage in its broader patent dispute with Merck. While the latest ruling does not guarantee a financial benefit for HALO, additional court wins could strengthen its position in any future licensing or settlement discussions with Merck.

Year to date, the company’s shares have surged 65% compared with the industry’s 1% growth.

Image Source: Zacks Investment Research

The Dispute Does Not Affect HALO’s ENHANZE BusinessHalozyme stated that the MDASE technology involved in the Merck dispute is separate from its ENHANZE technology and licensing program. This is particularly important for investors, given that ENHANZE is a major source of the company’s royalty revenues.

Halozyme has collaboration agreements with large pharma companies, like J&J (JNJ - Free Report) and argenx (ARGX - Free Report) , among others, which use its ENHANZE technology to develop SC formulations of their various approved drugs.

J&J uses the technology to administer the multiple myeloma therapy Darzalex (marketed as Darzalex Faspro/SC). On the other hand, argenx uses the same to deliver the generalized myasthenia gravis therapy Vyvgart, marketed as Vyvgart Hytrulo.

Per Halozyme, ENHANZE has been used in 10 commercialized products across more than 100 markets, while its growing number of partnerships provides further opportunities for milestone payments and royalties as new programs advance toward commercialization.

HALO’s Zacks RankHalozyme currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its third-quarter 2026 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, Oct. 29. During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available at www.merck.com.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

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

Forward-Looking statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

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

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20261001868272/en/

Merck (MRK.N) said on Wednesday its experimental drug significantly reduced ​inflammatory skin lesions in patients with a chronic skin disease, meeting the ‌main goal of a mid-stage study.

The results bolster Merck's push into immunology and could position the drug, tulisokibart, as a potential new treatment option for ​hidradenitis suppurativa, also known as acne inversa, which causes small, ​painful lumps to form under the skin.

In the study, ⁠72% of patients who received the highest dose of tulisokibart achieved at ​least a 50% reduction in inflammatory skin lesions after 16 weeks, ​compared with 35% of patients on placebo.

RBC Capital analysts had expected about 52% to 58% of patients to achieve at least a 50% reduction in inflammatory ​skin lesions.

About 41% of patients receiving the highest dose of the ​drug also achieved a tougher measure requiring at least a 75% reduction in ‌lesions, ⁠compared with 15% on placebo, Merck said.

The company added that safety was comparable between treatment and placebo groups.

Merck acquired tulisokibart through its $10.8 billion purchase of Prometheus Biosciences in 2023.

Tulisokibart, which succeeded in a late-stage ​chronic bowel disease study ​in June, ⁠is among the drugs Merck is counting on to help offset the eventual loss of exclusivity on ​Keytruda, its blockbuster cancer immunotherapy, later this decade.

RBC ​Capital analysts ⁠project the market for hidradenitis suppurativa treatments to exceed $10 billion by 2035.

Biologic medicines are currently used by a small proportion of patients and ⁠treatment ​rates are expected to increase as new ​therapies become available, the analysts said.

Currently approved treatments for the condition include AbbVie's (ABBV.N) Humira ​and Novartis' (NOVN.S) Cosentyx.

Key Takeaways Merck and Daiichi withdrew the FDA filing for ifinatamab deruxtecan in relapsed ES-SCLC.FDA discussions found available data did not support accelerated approval for the ADC candidate.Enrollment nears completion in phase III IDeate-Lung02, which could support a future filing. Merck (MRK - Free Report) and partner Daiichi Sankyo announced that they have voluntarily withdrawn a regulatory filing with the FDA seeking accelerated approval for an investigational antibody-drug conjugate (ADC) called ifinatamab deruxtecan in lung cancer.

The companies were seeking approval for the ADC candidate to treat adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

Why Did Merck & Daiichi Withdraw the Filing?The decision was based on discussions with the FDA, which indicated that the available data — including results from the phase II IDeate-Lung01 study — did not satisfy the requirements needed to support accelerated approval.

However, the companies continue to evaluate ifinatamab deruxtecan in ES-SCLC. Patient enrollment is nearing completion in the phase III IDeate-Lung02 study, which compares the ADC with physician’s-choice chemotherapy in patients with relapsed ES-SCLC after one prior line of platinum-based chemotherapy.

The companies could use data from this late-stage study to support a future regulatory filing for ifinatamab deruxtecan with the FDA and other global health authorities, depending on the results. Merck and Daiichi Sankyo are also evaluating the ADC in two additional late-stage studies for castration-resistant prostate cancer (CRPC) and esophageal squamous cell carcinoma (ESCC).

MRK’s Stock PerformanceThe company’s shares have risen 41% year-to-date compared with the industry’s 13% growth.

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Another Blow to Merck’s Daiichi Sankyo PartnershipIfinatamab deruxtecan is being co-developed by Merck and Daiichi as part of an agreement signed in 2023. This deal also involved two other ADCs, namely patritumab deruxtecan and raludotatug deruxtecan.

Notably, this is the second candidate being developed under the agreement that was voluntarily withdrawn. Last year, Merck and Daiichi voluntarily withdrew a filing with the FDA for patritumab to treat certain previously-treated adult patients with advanced non-small cell lung cancer (NSCLC). The filing had originally been submitted seeking accelerated approval based on results from the phase II HERTHENA-Lung01 study. However, the companies subsequently withdrew the submission after top-line overall survival results from the confirmatory phase III HERTHENA-Lung02 study failed to achieve statistical significance, following discussions with the FDA.

The latest setback could create an opportunity for competing ADCs being developed by GSK plc (GSK - Free Report) and Roche (RHHBY - Free Report) . Earlier this month, GSK’s risvutatug rezetecan (ris-rez) and Roche’s tambotatug pelitecan (tam-peli) delivered positive phase III results in relapsed SCLC in China. Ris-rez reduced the risk of death by 54% versus topotecan (a chemotherapy drug) in the ARTEMIS-008 study, while tam-peli achieved a similar 54% reduction in the risk of death versus topotecan in the TAISHAN-302 study.

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

Merck (MRK.N) and Daiichi Sankyo (4568.T) have withdrawn their US application seeking accelerated approval for an ​experimental lung cancer therapy, the companies said on Friday, marking ‌the second pullback under their multibillion-dollar cancer alliance.

The decision followed discussions with the US Food and Drug Administration, which determined that the data from a ​mid-stage clinical study testing the therapy, ifinatamab deruxtecan, did ​not satisfy requirements needed to support an early green light.

The ⁠therapy was under review to treat adults with an aggressive ​condition, known as extensive-stage small cell lung cancer, whose disease had ​worsened after standard chemotherapy.

Ifinatamab deruxtecan belongs to a class of targeted cancer therapies, called antibody-drug conjugates, which work like "guided missiles" by killing tumor cells while leaving ​healthy ones unharmed.

It is the second of the three "guided missile" therapies, ​co-developed by Merck and Daiichi under their 2023 partnership worth up to $22 billion, to ‌face ⁠a US application withdrawal. Last year, the companies pulled the application for another lung cancer candidate, patritumab deruxtecan, after it failed to extend the lives of patients in a late-stage study.

Ifinatamab deruxtecan, patritumab deruxtecan ​and a third ​therapy, raludotatug deruxtecan, ⁠are all part of the collaboration.

Despite the setback, the companies said they would continue evaluating ifinatamab ​deruxtecan. Patient enrollment is nearly complete for a larger, ​late-stage ⁠trial comparing the therapy against other standard chemotherapy options.

The companies plan to use the results from that study to seek approvals from the ⁠FDA and ​other global health regulators.

The therapy is ​also being evaluated in separate late-stage clinical trials for advanced prostate and esophageal cancers.

Key Takeaways AstraZeneca targets $80 billion in revenues by 2030, backed by 20 planned new medicine launches.Merck's Keytruda remains a major growth driver, with peak sales expected to reach $35 billion by 2028.Both face patent pressures. MRK trades at a higher forward P/E than AZN. AstraZeneca (AZN - Free Report) and Merck (MRK - Free Report) are leading global drugmakers with broad and diversified portfolios. Merck is based in the United States, while AstraZeneca is headquartered in Cambridge, UK. Both have strong positions in oncology, which remains a key growth driver for each company.

Oncology accounts for more than 60% of Merck’s pharmaceutical revenues, led by blockbuster Keytruda, which contributes more than half of pharma sales. At AstraZeneca, oncology represents about 46% of total revenues, with segment sales rising 15% at constant exchange rates in the first half of 2026. Beyond oncology, AstraZeneca has a strong presence in immunology, rare diseases, vaccines and cardiovascular/respiratory medicine. Merck’s portfolio also spans vaccines, neuroscience, diabetes, virology and animal health.

The two companies also collaborate on the PARP inhibitor Lynparza, highlighting their strategic relationship in oncology.

Both drugmakers continue to post solid revenue and earnings growth and have promising long-term pipelines. However, with the stocks trading at current levels, which offers the more compelling investment opportunity? Comparing their fundamentals, growth prospects, valuations and key risks can provide a clearer view of their relative risk-reward profiles.

The Case for MRK StockMerck boasts more than six blockbuster drugs in its portfolio, with Keytruda being the key top-line driver. Keytruda, approved for several types of cancers, has played an instrumental role in driving Merck’s steady revenue growth over the past few years. Though Keytruda will lose patent exclusivity in 2028, its sales are expected to remain strong until then.

The company expects Keytruda to achieve peak sales of $35 billion by 2028. Merck’s other oncology drugs, Welireg, AstraZeneca-partnered Lynparza and Eisai-partnered Lenvima, are also contributing to top-line growth.

MRK’s Animal Health business is also a key contributor to its top-line growth, with sales expected to more than double by the mid-2030s.

Merck’s expanding drug pipeline and potential new blockbuster drugs beyond Keytruda look encouraging. Its late-stage pipeline has expanded substantially since 2021, supported by in-house progress as well as the addition of candidates through M&A deals. Merck expects to launch 20 new drugs by 2030, with many already launched.

Its new products, pulmonary arterial hypertension drug Winrevair, cancer drug Welireg and 21-valent pneumococcal conjugate vaccine, Capvaxive, have begun to contribute significantly to top-line growth.

In a key pipeline development, last month Merck and partner Moderna (MRNA - Free Report) announced positive top-line data from a phase III study, which evaluated their personalized cancer therapy combo as an adjuvant treatment for patients with completely resected stage IIB-IV melanoma. The phase III INTerpath-001 study evaluated Moderna’s investigational mRNA-based individualized neoantigen therapy (“INT”), intismeran autogene, in combination with Keytruda. The study met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival.

Merck is actively pursuing acquisitions to prepare for Keytruda’s 2028 patent expiration. Recent deals added Ohtuvayre through Verona Pharma, influenza candidate MK-1406 through Cidara, and potential blockbuster cancer drug MK-4208 through Terns Pharmaceuticals.

However, sales of Merck’s second-largest product, its HPV vaccine Gardasil, have slowed down, with sales declining 9% in the first half of 2026 amid weaker demand in China, Japan and the United States. The outlook remains challenging, particularly in China, where economic weakness, elevated channel inventories and growing competition from lower-cost domestic HPV vaccines are expected to keep 2026 revenues immaterial, while changes in U.S. vaccination recommendations are also weighing on demand.

Merck is heavily reliant on Keytruda. While Keytruda may be Merck’s biggest strength and a solid reason to own the stock, the company is excessively dependent on the drug. Keytruda’s core U.S. patent is expected to expire around 2028, with additional patents expiring shortly thereafter. Keytruda is expected to face significant biosimilar competition around 2028-2029. Once biosimilars enter the market, Keytruda’s sales are likely to decline sharply.

Merck faces continued revenue pressure from declining demand for its diabetes drugs Januvia/Janumet and increasing generic erosion across products such as Isentress/Isentress HD, Bridion and Dificid.

The Case for AZN StockAstraZeneca now has 16 blockbuster medicines, including Tagrisso, Fasenra, Farxiga, Imfinzi, Lynparza, Soliris and Ultomiris in its portfolio, with sales (product sales and alliance revenues) exceeding $1 billion. These drugs are driving AstraZeneca’s top-line growth, backed by increasing demand trends.

Newer drugs like Wainua, Airsupra, Saphnelo, Datroway (partnered with Daiichi Sankyo) and Truqap are also contributing to top-line growth, more than offsetting the LOE of some mature brands like Brilinta, Pulmicort and Soliris.

AZN expects continued revenue and earnings growth in 2026. It expects total revenues to grow by a mid-to-high single-digit percentage at CER in 2026, while core EPS is expected to increase by a low double-digit percentage at CER. The company is also on track to achieve a mid-30s percentage core operating margin by 2026.

AstraZeneca has set itself some visible targets for the next few years. It expects to generate $80 billion in total revenues by 2030. By that time frame, AstraZeneca plans to launch 20 new medicines, with around 11 already launched/approved. Two new drugs, Etcamah in breast cancer and Baxfendy in hypertension, are already approved this year.

AstraZeneca believes that many of these new medicines, like Datroway, Etcamah and Baxfendy, have peak-year revenue potential of more than $5 billion. Beyond these launches, AstraZeneca also boasts a broad portfolio of late-stage assets that are expected to deliver pivotal data before 2030, including multiple programs with multi-blockbuster potential. AstraZeneca expects a rich catalyst path ahead with several high-value readouts due over the next 18 months.

However, despite solid underlying financial performance, AstraZeneca faces its share of challenges. The loss of exclusivity of mature brands like Brilinta, Pulmicort and Soliris is hurting sales. Generic versions of one of the company's major drugs, Farxiga, have been launched in the United Kingdom, United States, Japan and China, and revenues are declining sharply.

China, though an important market for AstraZeneca, remains a somewhat uncertain market due to pricing pressure from volume-based procurement (VBP) programs and ongoing legal and compliance investigations involving the company’s former China head, Leon Wang. China contributes roughly 12% of the company's revenues. AZN’s stock has also taken a beating recently, with the company facing several pipeline setbacks in the past few months.

How Do Estimates Compare for AZN & MRK?The Zacks Consensus Estimate for AZN’s 2026 sales and EPS implies a year-over-year increase of 7.6% and 2.0%, respectively. EPS estimates for 2026 have declined from $10.22 per share to $9.34 per share over the past 60 days, while those for 2027 have declined from $11.47 to $10.54 over the same timeframe.

AZN Estimate MovementImage Source: Zacks Investment Research

The Zacks Consensus Estimate for MRK’s 2026 sales implies a year-over-year increase of 3.6%, while EPS is expected to decline 66.9%. EPS estimates for 2026 have declined from $3.21 to $2.97 over the past 60 days, while those for 2027 have declined from $9.71 to $9.66 over the same timeframe.

MRK Estimate MovementImage Source: Zacks Investment Research

Price Performance and Valuation of AZN & MRKSo far this year, AstraZeneca’s stock has declined 9.7% against the industry’s increase of 12.2%. Merck’s stock has risen 39.5%.

Image Source: Zacks Investment Research

MRK looks slightly more attractive than AstraZeneca from a valuation standpoint. Going by the price/earnings ratio, AstraZeneca’s shares currently trade at 16.27 forward earnings, lower than 18.18 for the industry as well as the stock’s 5-year mean of 17.32. Merck’s shares currently trade at 18.80 forward earnings, higher than the industry as well as the stock’s 5-year mean of 12.94.

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AstraZeneca’s dividend yield is 2.6%, while Merck’s is higher at 2.3%.

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AZN or MRK: Which is a Better Pick?Merck has a Zacks Rank #3 (Hold), while AstraZeneca has a Zacks Rank #5 (Strong Sell), which makes the former a clear winner.

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

AstraZeneca’s stock has declined this year, accompanied by downward revisions to earnings estimates. In addition, several of the company’s established medicines are facing patent expirations and pricing pressures, creating uncertainty about whether revenues from these mature products can be replaced quickly enough by newer launches and pipeline candidates. The company has also experienced several recent clinical setbacks.

On the other hand, Merck has one of the world’s best-selling drugs in its portfolio, generating billions of dollars in revenues. Though Keytruda will lose patent exclusivity in 2028, its sales are expected to remain strong until then. 

Moreover, its new products, strong progress in its pipeline, and business development and acquisitions have increased confidence that Merck may be able to maintain growth even after Keytruda loses exclusivity.

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer (MIBC). This recommendation, which also includes KEYTRUDA SC® [known as KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway. A final decision is expected by the fourth quarter of 2026.

“Despite advances in the treatment of muscle-invasive bladder cancer, recurrence remains a significant concern for many patients regardless of cisplatin eligibility, and up to half may be unable to receive cisplatin-based chemotherapy,” said Dr. Marjorie Green, senior vice president, oncology, global clinical development, Merck Research Laboratories. “If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for people with muscle-invasive bladder cancer regardless of cisplatin eligibility, expanding on the previously approved indication.”

The recommendation is based on results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), which was conducted in collaboration with Pfizer and Astellas. In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant improvement in event-free survival (EFS), reducing the risk of EFS events (defined as disease progression, recurrence or death) by 47% (HR=0.53 [95% CI, 0.41-0.70]; p<0.0001; 87/405 [21%] versus 146/403 [36%]) in patients with MIBC who are eligible for cisplatin-based chemotherapy compared to neoadjuvant chemotherapy (gemcitabine and cisplatin) and surgery. KEYTRUDA plus Padcev also demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 35% (HR=0.65 [95% CI, 0.48-0.89]; p=0.0029; 69/405 [17%] versus 99/403 [25%]) in these patients when compared to neoadjuvant chemotherapy and surgery. The trial showed KEYTRUDA plus Padcev demonstrated a statistically significant improvement in pathologic complete response (pCR) rate compared to neoadjuvant chemotherapy (55.8% [95% CI: 50.8, 60.7] versus 32.5% [95% CI: 28.0, 37.3]; p<0.0001).

In June 2026, the EC approved KEYTRUDA, which also includes KEYTRUDA SC, in combination with Padcev, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy based on the Phase 3 KEYNOTE-905 trial.

In July 2026, KEYTRUDA in combination with Padcev was approved by the U.S. Food and Drug Administration (FDA) as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with MIBC based on the Phase 3 KEYNOTE-B15 trial. This also represented the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimen approved in the U.S. for adults with MIBC regardless of cisplatin eligibility.

About bladder cancer
Bladder cancer is the eighth most common cancer worldwide, diagnosed in more than 635,000 patients each year globally. In Europe, it is estimated there were approximately 224,700 patients diagnosed with bladder cancer and more than 70,300 deaths from the disease in 2022. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence. Additionally, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone.

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

About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

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

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)
Urothelial Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with enfortumab vedotin-ejfv, for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In KEYNOTE-B96, when KEYTRUDA in combination with paclitaxel, with or without bevacizumab, was administered to patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1), serious adverse reactions occurred in 54% of patients receiving KEYTRUDA and paclitaxel with or without bevacizumab. Serious adverse reactions in ≥2% of patients were pneumonia (4.3%), urinary tract infection (3.9%), adrenal insufficiency, hyponatremia (3% each), COVID-19, decreased neutrophil count, pulmonary embolism (2.6% each), abdominal pain, anemia, colitis, diarrhea, febrile neutropenia, pyrexia, and vomiting (2.1% each).

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

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

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

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

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

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

The safety and effectiveness of KEYTRUDA QLEX for the treatment of pediatric patients 12 years and older who weigh greater than 40 kg have been established for:

Stage IIB, IIC, or III melanoma following complete resection Unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors Recurrent locally advanced or metastatic Merkel cell carcinoma Use of KEYTRUDA QLEX in pediatric patients for these indications is supported by evidence from adequate and well-controlled studies of KEYTRUDA in adults and additional pharmacokinetic and safety data for KEYTRUDA in pediatric patients 12 years and older. Pembrolizumab exposures in pediatric patients 12 years and older who weigh greater than 40 kg are predicted to be within range of those observed in adults at the same dosage.

The safety and effectiveness of KEYTRUDA as a single agent have been established in pediatric patients with melanoma (stage IIB, IIC, or III melanoma following complete resection in pediatric patients 12 and older), MCC, and MSI-H or dMMR cancer.

Use of KEYTRUDA in pediatric patients for these indications is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients.

The safety and effectiveness of KEYTRUDA QLEX have not been established in pediatric patients younger than 12 years of age for the treatment of melanoma, MCC, and MSI-H or dMMR cancer.

The safety and effectiveness of KEYTRUDA and KEYTRUDA QLEX have not been established in pediatric patients for other approved indications shown.

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

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

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

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

Additional Selected Indications in the U.S. for KEYTRUDA and KEYTRUDA QLEX
Melanoma
KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with unresectable or metastatic melanoma.

KEYTRUDA and KEYTRUDA QLEX are each indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

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

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the first-line treatment of adult patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations, and is:

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

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

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

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

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

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

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

KEYTRUDA and KEYTRUDA QLEX, as single agents, are each indicated for the treatment of adult patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. For this indication, KEYTRUDA also is indicated for the treatment of pediatric patients, and KEYTRUDA QLEX also is indicated for the treatment of pediatric patients 12 years and older.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test.

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

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

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

in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, or as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. Cervical Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with chemoradiotherapy (CRT), for the treatment of adult patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA).

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

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

Hepatocellular Carcinoma
KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1–containing regimen.

Biliary Tract Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

Merkel Cell Carcinoma
KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). For this indication, KEYTRUDA also is indicated for the treatment of pediatric patients, and KEYTRUDA QLEX also is indicated for the treatment of pediatric patients 12 years and older.

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.

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

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

Cutaneous Squamous Cell Carcinoma
KEYTRUDA and KEYTRUDA QLEX are each indicated for the treatment of adult patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

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

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

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

Ovarian Cancer
KEYTRUDA and KEYTRUDA QLEX are each indicated, in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.

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

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

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

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

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

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

Please see Prescribing Information for KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) at https://www.merck.com/product/usa/pi_circulars/k/keytruda_qlex/keytruda_qlex_pi.pdf and Medication Guide for KEYTRUDA QLEX at https://www.merck.com/product/usa/pi_circulars/k/keytruda_qlex/keytruda_qlex_mg.pdf.

More News From Merck & Co., Inc.

Commercial orbital laboratories could extend proven microgravity research, but regulation and return logistics remain unresolved. Summary

Space research already helped Keytruda; repeating that success requires new infrastructure.

Merck MRK, the pharmaceutical and oncology heavyweight, entered the next era of commercial space research with something unusually concrete: a medicine already benefiting from work conducted in orbit. Shares rose approximately 1.0% to $146.39 Thursday, based on the latest market price.

Research aboard the International Space Station helped scientists better understand protein crystallization, contributing to the development of a faster subcutaneous formulation of blockbuster cancer drug Keytruda. NASA's research overview explains that microgravity can produce larger and more orderly protein crystals, potentially giving researchers clearer structural information. As the ISS approaches retirement, commercial stations could offer drugmakers dedicated equipment and more predictable research schedules, although regulators still lack a purpose-built approval framework for medicines manufactured in space.

The commercial stakes are already enormous. Keytruda generated about $8.37 billion of Merck's latest $16.61 billion quarter, roughly half of total revenue, while the subcutaneous version contributed $463 million, or around 5.5% of Keytruda sales. The valuation picture adds another wrinkle: at $146.39, Merck trades 21.85% above its GF Value™ estimate of $120.14, signaling that investors are already paying a meaningful premium to the model's estimate of fair value. Space-based research has moved beyond scientific curiosity for Merck; the harder question is whether future orbital breakthroughs can become commercially meaningful medicines often enough to justify the cost, complexity and regulatory uncertainty.

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

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SEATTLE, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective,” the “Company,” “we,” “us,” and “our”) (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, today announced a clinical trial collaboration agreement with Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

The agreement supports the evaluation of Perspective’s targeted alpha-particle therapy [212Pb]PSV359 in combination with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy. This combination will be evaluated under an amendment to the Company’s ongoing Phase 1/2a study of [212Pb]PSV359 in patients with certain types of non-small cell lung cancer and colorectal cancer that express fibroblast activation protein alpha (FAP-α) (clinicaltrials.gov identifier NCT06710756). The study has completed enrollment in the first three monotherapy dose cohorts.

Perspective is sponsoring the study, and Merck is providing pembrolizumab at no cost.

“FAP-α is associated with the majority of solid tumors and with a tumor microenvironment historically characterized by poor drug penetration and immune suppression or exclusion,” said Markus Puhlmann, Perspective’s Chief Medical Officer. “By combining targeted radiopharmaceutical treatment with a well-established immune checkpoint inhibitor, we aim to evaluate whether this approach can reshape the tumor environment and potentially improve treatment outcomes for patients with advanced FAP-α-positive solid tumors.”

About FAP-α

FAP-α is a protein abundantly expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma, a part of the tumor microenvironment (TME) in the majority of epithelial cancers. In addition to expression on CAFs, FAP-α is expressed on certain cancer cells themselves, including sarcomas and mesotheliomas.1,2,3,4 Higher FAP-α expression has been found to be associated with poor prognosis in a number of solid tumors such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, stomach cancer, mesothelioma, head and neck cancer, esophageal cancer, and ovarian cancer.5,6,7,8,9,10 Expression of FAP-α in healthy tissues is usually low.3,4

About PSV359

PSV359 was designed to target and deliver 212Pb to tumor sites expressing FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga (known as PSV377) to detect FAP-α expression in individual patients. Preclinical imaging and therapy as well as human imaging results suggest Perspective's proprietary targeting ligand has improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues, which may result in a desirable therapeutic index.

Perspective is conducting a multi-center, open-label, dose-finding and dose-expansion study (clinicaltrials.gov identifier NCT06710756) of [212Pb]PSV359 in patients with advanced solid tumors that express FAP-α as determined by imaging with [203Pb]PSV359. The primary objective of the dose finding phase of the study is to assess the safety and tolerability of various doses of [212Pb]PSV359 in order to determine the recommended Phase 2 dose to be used in the expansion phase of the study, where anti-tumor activities may be an additional primary outcome measure.

About Perspective Therapeutics, Inc.

Perspective Therapeutics, Inc. is a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-generating isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging techniques that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables visualization of the specific tumor and subsequent treatment, potentially improving efficacy and minimizing toxicity.

The Company is advancing a portfolio of clinical-stage programs in the U.S., including bamzireotide navoxetan (VMT-α-NET, neuroendocrine tumors), lapemelanotide zapixetar (VMT01, melanoma), and PSV359 (solid tumors).

The Company is expanding its regional finished drug product candidate supply network, enabled by its proprietary 224Ra/212Pb generator platform used to manufacture clinical drug product candidates, to support the delivery of patient-ready drug product candidates for clinical trials and, if approved, commercial operations.

For more information, please visit the Company's website at www.perspectivetherapeutics.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "estimate," "believe," "predict," "potential," or "continue" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company’s preclinical and clinical development plans and the expected timing for the release of additional data from its clinical programs; the Company’s beliefs that its product candidates address certain unmet medical needs; the Company’s expectations regarding regulatory pathways for its product candidates; the Company’s expectations regarding its interactions with regulatory agencies and the expected timing thereof; the Company’s regional distribution and manufacturing capabilities; and other statements that are not historical fact.

The Company may not actually achieve the plans, intentions, or expectations disclosed in the forward-looking statements, and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Known risk factors include that the Company’s clinical trials may be more costly or take longer to complete than anticipated, or may never be completed, or may not generate results that warrant future development of the tested product candidate; the Company may elect to change its strategy regarding its product candidates and clinical development activities; economic and market conditions may worsen; and risks related to the sufficiency of the Company’s cash resources for its future operating expenses and capital expenditures. A more complete discussion of the risks and uncertainties facing the Company appears under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”), in the Company’s other filings with the SEC, and in the Company’s future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Media and Investor Relations Contacts:

Perspective Therapeutics IR:
Annie J. Cheng, CFA
[email protected]

ENTENTE Network of Companies
Katie Morris, PhD
[email protected]

1 Garin-Chesa P, Old LJ, Rettig WJ. Cell surface glycoprotein of reactive stromal fibroblasts as a potential antibody target in human epithelial cancers. Proc Natl Acad Sci U S A. 1990;87(18):7235-7239. doi:10.1073/pnas.87.18.7235
2 Dziadek S, Kraxner A, Cheng WY, et al. Comprehensive analysis of fibroblast activation protein expression across 23 tumor indications: insights for biomarker development in cancer immunotherapies. Front Immunol. 2024;15:1352615. Published 2024 Mar 15. doi:10.3389/fimmu.2024.1352615
3 Kratochwil C, Flechsig P, Lindner T, et al. 68Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019;60(6):801-805. doi:10.2967/jnumed.119.227967
4 Fitzgerald AA, Weiner LM. The role of fibroblast activation protein in health and malignancy. Cancer Metastasis Rev. 2020;39(3):783-803. doi:10.1007/s10555-020-09909-3
5 Cords L, Engler S, Haberecker M, et al. Cancer-associated fibroblast phenotypes are associated with patient outcome in non-small cell lung cancer. Cancer Cell. 2024;42(3):396-412.e5. doi:10.1016/j.ccell.2023.12.021
6 Coto-Llerena M, Ercan C, Kancherla V, et al. High Expression of FAP in Colorectal Cancer Is Associated With Angiogenesis and Immunoregulation Processes. Front Oncol. 2020;10:979. Published 2020 Jul 8. doi:10.3389/fonc.2020.00979
7 Henry LR, Lee HO, Lee JS, et al. Clinical implications of fibroblast activation protein in patients with colon cancer. Clin Cancer Res. 2007;13(6):1736-1741. doi:10.1158/1078-0432.CCR-06-1746
8 Wang S, Zheng Y, Yang F, et al. The molecular biology of pancreatic adenocarcinoma: translational challenges and clinical perspectives. Signal Transduct Target Ther. 2021;6(1):249. Published 2021 Jul 5. doi:10.1038/s41392-021-00659-4
9 Cohen SJ, Alpaugh RK, Palazzo I, et al. Fibroblast activation protein and its relationship to clinical outcome in pancreatic adenocarcinoma. Pancreas. 2008;37(2):154-158. doi:10.1097/MPA.0b013e31816618ce
10 Ma C, Xi S, Sun, H, et al. Identifying the oncogenic roles of FAP in human cancers based on systematic analysis. Aging 2023;15(14):7056-7083. doi: 10.18632/aging.204892

Archford Capital Strategies LLC lessened its stake in Merck & Co., Inc. (NYSE:MRK – Free Report) by 20.4% in the 2nd quarter, according to the company in its most recent Form 13F filing with the SEC. The firm owned 27,354 shares of the company’s stock after selling 6,991 shares during the period. Archford Capital Strategies LLC’s holdings in Merck & Co., Inc. were worth $3,515,000 at the end of the most recent reporting period.

Other institutional investors have also added to or reduced their stakes in the company. Kingdom Financial Group LLC. acquired a new position in Merck & Co., Inc. in the fourth quarter worth about $25,000. Abound Financial LLC bought a new position in shares of Merck & Co., Inc. during the 4th quarter worth approximately $26,000. Prosperity Bancshares Inc acquired a new stake in Merck & Co., Inc. in the 4th quarter valued at $26,000. High Note Wealth LLC boosted its stake in Merck & Co., Inc. by 58.9% in the 4th quarter. High Note Wealth LLC now owns 294 shares of the company’s stock valued at $31,000 after buying an additional 109 shares in the last quarter. Finally, IFC & Insurance Marketing Inc. bought a new stake in Merck & Co., Inc. in the fourth quarter valued at $31,000. 76.07% of the stock is owned by institutional investors and hedge funds.

Key Merck & Co., Inc. News Here are the key news stories impacting Merck & Co., Inc. this week:

Positive Sentiment: Analyst upgrades support valuation: Leerink Partners raised its price target from $127 to $161 and maintained an “outperform” rating, while Guggenheim increased its target from $146 to $170 and assigned a “buy” rating. The revisions suggest analysts see further upside from Merck’s commercial execution and pipeline. Benzinga analyst rating reports Positive Sentiment: Pipeline expansion addresses the Keytruda patent cliff: Merck is pairing antibody-drug conjugates (ADCs) with Keytruda in women’s cancers, seeking to improve outcomes in difficult-to-treat tumors while building future revenue sources before Keytruda faces patent pressure. Merck pairs ADCs with Keytruda in women’s cancer push Neutral Sentiment: Investor attention is focused on management commentary: Merck presented at the Wells Fargo 21st Annual Healthcare Conference and is scheduled to participate in Morgan Stanley’s global healthcare conference. These events may provide additional detail on Keytruda demand, pipeline progress and long-term growth plans. Wells Fargo healthcare conference transcript Neutral Sentiment: Keytruda and new products remain central to the bull case: Commentary highlights Keytruda’s current growth contribution and Merck’s efforts to develop products capable of extending momentum beyond the anticipated 2028 patent cliff. MRK’s strong recent performance and elevated valuation leave expectations high. Merck trading near 52-week high Negative Sentiment: Long-term patent risk remains: Investors are watching whether Merck can replace revenue that may be lost when Keytruda’s exclusivity weakens. The company’s ability to commercialize ADC combinations and other pipeline assets is therefore critical to sustaining growth and its current valuation. Merck outlook and GARDASIL commentary Wall Street Analysts Forecast Growth Several research analysts have issued reports on the company. Barclays increased their price objective on Merck & Co., Inc. from $140.00 to $150.00 and gave the stock an “overweight” rating in a research note on Wednesday, July 29th. Morgan Stanley raised shares of Merck & Co., Inc. from an “equal weight” rating to an “overweight” rating and upped their target price for the stock from $116.00 to $179.00 in a report on Thursday, August 20th. Wall Street Zen upgraded shares of Merck & Co., Inc. from a “hold” rating to a “buy” rating in a research report on Saturday, August 22nd. Bank of America lifted their price target on shares of Merck & Co., Inc. from $130.00 to $141.00 and gave the company a “buy” rating in a report on Tuesday, June 30th. Finally, Wolfe Research raised their price objective on shares of Merck & Co., Inc. from $155.00 to $180.00 and gave the stock an “outperform” rating in a report on Tuesday, August 25th. Sixteen research analysts have rated the stock with a Buy rating and eight have issued a Hold rating to the company’s stock. According to data from MarketBeat.com, the stock has a consensus rating of “Moderate Buy” and a consensus target price of $150.33. Check Out Our Latest Report on Merck & Co., Inc.

Insider Transactions at Merck & Co., Inc. In related news, EVP Richard R. Deluca sold 11,699 shares of the business’s stock in a transaction that occurred on Wednesday, August 12th. The shares were sold at an average price of $131.63, for a total transaction of $1,539,939.37. Following the completion of the sale, the executive vice president directly owned 110,167 shares of the company’s stock, valued at $14,501,282.21. The trade was a 9.60% decrease in their ownership of the stock. The transaction was disclosed in a filing with the SEC, which is available at this link. Also, EVP David R. Maraldo sold 18,706 shares of the business’s stock in a transaction that occurred on Wednesday, August 5th. The stock was sold at an average price of $128.72, for a total transaction of $2,407,836.32. Following the sale, the executive vice president directly owned 18,212 shares of the company’s stock, valued at approximately $2,344,248.64. This trade represents a 50.67% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. Over the last 90 days, insiders sold 228,238 shares of company stock valued at $29,977,783. 0.17% of the stock is currently owned by insiders.

Merck & Co., Inc. Price Performance Merck & Co., Inc. stock opened at $147.69 on Thursday. The business’s fifty day moving average is $135.91 and its two-hundred day moving average is $124.10. The company has a debt-to-equity ratio of 1.22, a quick ratio of 1.10 and a current ratio of 1.32. The firm has a market cap of $364.37 billion, a P/E ratio of 118.15, a P/E/G ratio of 6.46 and a beta of 0.21. Merck & Co., Inc. has a 52 week low of $77.58 and a 52 week high of $156.92.

Merck & Co., Inc. (NYSE:MRK – Get Free Report) last announced its earnings results on Tuesday, August 4th. The company reported ($0.13) earnings per share for the quarter, beating analysts’ consensus estimates of ($0.26) by $0.13. The company had revenue of $16.61 billion during the quarter, compared to analyst estimates of $16.37 billion. Merck & Co., Inc. had a return on equity of 16.73% and a net margin of 4.77%.The firm’s quarterly revenue was up 5.1% compared to the same quarter last year. During the same period last year, the company posted $2.13 earnings per share. Merck & Co., Inc. has set its FY 2026 guidance at 2.660-2.760 EPS. Equities research analysts forecast that Merck & Co., Inc. will post 2.76 earnings per share for the current fiscal year.

Merck & Co., Inc. Announces Dividend The company also recently declared a quarterly dividend, which will be paid on Wednesday, October 7th. Investors of record on Tuesday, September 15th will be issued a $0.85 dividend. The ex-dividend date is Tuesday, September 15th. This represents a $3.40 annualized dividend and a yield of 2.3%. Merck & Co., Inc.’s dividend payout ratio (DPR) is currently 272.00%.

About Merck & Co., Inc. (Free Report)

Merck & Co, Inc is a global healthcare company that develops, manufactures, and markets prescription medicines, vaccines, and animal-health products. The company serves patients, healthcare providers, and customers in markets worldwide through its Human Health and Animal Health businesses.

Merck’s pharmaceutical portfolio includes oncology, infectious disease, cardiology, immunology, and other therapeutic areas. Its products include Keytruda, an immunotherapy used to treat various cancers; Gardasil, a vaccine that helps protect against human papillomavirus (HPV); and Januvia, a treatment for type 2 diabetes.

Read More Five stocks we like better than Merck & Co., Inc. Qualcomm’s Data Center Bet Looks More Real After Amazon’s AI Deal GE Aerospace’s $11.75B Deal Puts Howmet Aerospace in Focus Casey’s Post-Earnings Drop May Give Investors a Better Entry Into a Quality Retailer Sovereign AI: Palantir and Nebius Cut the Cloud Cord Want to see what other hedge funds are holding MRK? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Merck & Co., Inc. (NYSE:MRK – Free Report).

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Cipla secured exclusive U.S. commercialization rights to Qilu's proposed biosimilar ahead of Keytruda's expected 2028 patent expiration. Summary

Merck must strengthen its Keytruda defense before potential U.S. biosimilar competition arrives.

Merck MRK, the pharmaceutical and vaccine heavyweight priced at $151.07, got a blunt warning Thursday: Keytruda's biosimilar countdown is getting louder. Cipla's U.S. subsidiary secured exclusive American commercialization rights to Qilu Pharmaceutical's proposed pembrolizumab biosimilar, QL2107, ahead of Keytruda's expected 2028 core patent expiration.

This is not an overnight threat. Qilu must still complete development, win regulatory approval and prove it can manufacture a comparable product at scale. Cipla takes over only if QL2107 reaches the U.S. market. The timing remains uncertain, but the direction is crystal clear: lower-priced competition is lining up, and Merck's window to protect its biggest franchise is narrowing.

Merck posted $8.4 billion in quarterly Keytruda and Keytruda Qlex sales, including $463 million from the newer subcutaneous version. Qlex already contributes about 5.5% of franchise revenue, making it a key part of Merck's patent-cliff defense. Yet investors are paying up: the $151.07 share price sits 25.87% above the $120.02 GF Value. That premium raises the stakes—Merck must move patients to Qlex, widen Keytruda's reach and build its next growth engine before biosimilars arrive.

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

Click for the complete disclosure

Key Takeaways Merck-Moderna's cancer vaccine met its Phase 3 goal in high-risk melanoma.Moderna surged 177%, whereas Merck gained 12.6% after the trial update.IDNA, PPH, CANC and XBI offer ETF exposure to MRK or MRNA. Merck (MRK - Free Report) and Moderna (MRNA - Free Report) delivered a significant breakthrough in melanoma treatment, with their jointly developed mRNA cancer vaccine showing positive results in its first-ever Phase 3 trial. This vaccine, combined with Merck’s exemplary immunotherapy Keytruda, met the primary goal of significantly extending the period patients lived without melanoma returning compared with Keytruda alone.

The immediate market reaction highlighted how important the trial could be for both healthcare stocks. On Aug. 19, Moderna’s shares skyrocketed nearly 177% following the announcement, whereas Merck rose 12.60%.

With rising incidence of skin cancers worldwide, along with the rapid adoption of innovative immuno-oncology drugs, the latest development puts a spotlight on MRK and MRNA, as well as healthcare exchange-traded funds (ETFs) holding them.

Immunotherapy Gaining Prominence in Melanoma TreatmentMelanoma treatment has evolved substantially over the past decade as checkpoint inhibitors and targeted therapies have replaced many older chemotherapy approaches.While traditional chemotherapy works by directly attacking rapidly dividing cells, immunotherapy helps the patient's immune system to destroy cancer cells and has led to significant progress in treating patients with advanced melanoma over the past few years.

Per the Institute of Cancer Research’s data published in 2024, more than 52% of people diagnosed with advanced melanoma are now surviving the disease for 10 years or more when they receive a combination immunotherapy treatment compared with only 1 in 20 patients with advanced melanoma surviving for five years, just 15 years ago.

Consequently, immunotherapy drugs like Merck’s Keytruda or Bristol Myers Squibb’s (BMY - Free Report) Nivolumab are gaining strong traction in melanoma treatment.

What Are Market Growth Prospects?With an estimated 234,680 cases of melanoma expected to be diagnosed in the United States in 2026, melanoma treatment, particularly immunotherapy, offers solid market growth opportunities.

To this end, the global melanoma therapeutics market, estimated at $5.83 billion in 2024, is projected to reach $10.27 billion by 2030, witnessing a 9.9% CAGR, according to Grand View Research. Importantly, immunotherapy is the largest and fastest-growing product segment, with the global melanoma immunotherapy market estimated to see a CAGR of 11.7% to reach $4.62 billion by 2030.

Against this backdrop, the latest breakthrough achieved by the cancer vaccine, co-developed by Merck and Moderna, should help these stocks capture a larger portion of the aforementioned melanoma immunotherapy market.

ETFs to WatchReuters reported that Barclays analysts estimate the Merck-Moderna vaccine to generate up to $3 billion in annual melanoma-related sales by 2035.

Against this backdrop, ETF investors eager to capitalize on the expected benefits of this vaccine breakthrough may want to gain exposure to the following healthcare ETFs, which hold Merck or Moderna or both.

iShares Genomics Immunology and Healthcare ETF (IDNA - Free Report) is a thematic healthcare ETF designed to capture long-term growth of genomics, immunology and bioengineering. MRNA holds 8.85% of this fund, enjoying the first spot, whereas MRK holds 3.66% at the seventh position.

It has net assets worth $256.7 million and an expense ratio of 0.47%. The fund trades at an average daily volume of 90,628 shares.

VanEck Pharmaceutical ETF (PPH - Free Report) is a focused healthcare ETF that provides exposure to major drugmakers and pharmaceutical companies globally. MRK holds 10.94% of this fund, enjoying the second spot.

It has total net assets worth $1.03 billion and an expense ratio of 0.36%. The fund trades at an average daily volume of 280,123 shares.

Tema Oncology ETF (CANC - Free Report) is an actively managed thematic ETF offering exposure to biotech companies shaping the future of cancer therapeutics and care. MRK holds a weightage of 3.56% in this fund, enjoying the seventh position.

It has assets under management worth $211.1 million and an expense ratio of 0.75%. The fund trades at an average daily volume of 33,006 shares.

State Street SPDR S&P Biotech ETF (XBI - Free Report) provides exposure to biotechnology stocks. MRNA holds 2.76% of its portfolio, having the first position.

It has assets under management worth nearly $11.40 billion and an expense ratio of 0.35%. The fund trades at an average daily volume of 9.02 million shares.

71 West Capital Partners increased its stake in shares of Merck & Co., Inc. (NYSE:MRK – Free Report) by 46.2% in the 2nd quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission. The institutional investor owned 16,058 shares of the company’s stock after buying an additional 5,071 shares during the quarter. 71 West Capital Partners’ holdings in Merck & Co., Inc. were worth $2,063,000 at the end of the most recent quarter.

Other institutional investors and hedge funds have also bought and sold shares of the company. Kingdom Financial Group LLC. bought a new position in shares of Merck & Co., Inc. during the 4th quarter valued at approximately $25,000. Abound Financial LLC purchased a new stake in Merck & Co., Inc. in the fourth quarter worth $26,000. Prosperity Bancshares Inc bought a new position in shares of Merck & Co., Inc. during the 4th quarter worth $26,000. High Note Wealth LLC grew its stake in shares of Merck & Co., Inc. by 58.9% during the 4th quarter. High Note Wealth LLC now owns 294 shares of the company’s stock worth $31,000 after acquiring an additional 109 shares during the period. Finally, IFC & Insurance Marketing Inc. bought a new position in shares of Merck & Co., Inc. during the 4th quarter worth $31,000. 76.07% of the stock is owned by hedge funds and other institutional investors.

Merck & Co., Inc. Trading Up 2.3% Shares of MRK opened at $152.43 on Friday. The stock has a market capitalization of $376.07 billion, a P/E ratio of 121.94, a PEG ratio of 6.43 and a beta of 0.19. Merck & Co., Inc. has a twelve month low of $77.58 and a twelve month high of $154.49. The company has a quick ratio of 1.10, a current ratio of 1.32 and a debt-to-equity ratio of 1.22. The firm has a fifty day simple moving average of $128.09 and a two-hundred day simple moving average of $121.23.

Merck & Co., Inc. (NYSE:MRK – Get Free Report) last released its quarterly earnings results on Tuesday, August 4th. The company reported ($0.13) EPS for the quarter, beating analysts’ consensus estimates of ($0.26) by $0.13. Merck & Co., Inc. had a return on equity of 16.73% and a net margin of 4.77%.The business had revenue of $16.61 billion during the quarter, compared to analyst estimates of $16.37 billion. During the same quarter in the prior year, the company posted $2.13 EPS. Merck & Co., Inc.’s quarterly revenue was up 5.1% compared to the same quarter last year. Merck & Co., Inc. has set its FY 2026 guidance at 2.660-2.760 EPS. On average, research analysts anticipate that Merck & Co., Inc. will post 2.77 EPS for the current year. Merck & Co., Inc. Dividend Announcement The business also recently declared a quarterly dividend, which will be paid on Wednesday, October 7th. Investors of record on Tuesday, September 15th will be issued a $0.85 dividend. The ex-dividend date is Tuesday, September 15th. This represents a $3.40 annualized dividend and a yield of 2.2%. Merck & Co., Inc.’s payout ratio is 272.00%.

Analyst Upgrades and Downgrades A number of equities analysts have weighed in on the stock. Bank of America increased their target price on shares of Merck & Co., Inc. from $130.00 to $141.00 and gave the stock a “buy” rating in a research report on Tuesday, June 30th. BMO Capital Markets boosted their price target on shares of Merck & Co., Inc. from $142.00 to $170.00 and gave the company an “outperform” rating in a research report on Thursday. Jefferies Financial Group lowered Merck & Co., Inc. from a “strong-buy” rating to a “hold” rating in a report on Wednesday. Weiss Ratings downgraded Merck & Co., Inc. from a “hold (c)” rating to a “hold (c-)” rating in a research note on Tuesday, August 11th. Finally, The Goldman Sachs Group lifted their target price on Merck & Co., Inc. from $140.00 to $160.00 and gave the company a “buy” rating in a report on Friday. Fifteen equities research analysts have rated the stock with a Buy rating and eight have issued a Hold rating to the company. According to MarketBeat, the stock presently has an average rating of “Moderate Buy” and an average target price of $144.10.

View Our Latest Stock Report on Merck & Co., Inc.

Trending Headlines about Merck & Co., Inc. Here are the key news stories impacting Merck & Co., Inc. this week:

Positive Sentiment: Merck and Moderna reported that their personalized cancer therapy met key Phase 3 goals, improving recurrence-free and distant metastasis-free survival for high-risk melanoma patients when added to Keytruda. The result is the first major late-stage win for an mRNA cancer vaccine and strengthens the potential for regulatory approval and broader oncology applications. MRK/MRNA’s Personalized Cancer Therapy Delivers First Phase III Win Positive Sentiment: Several Wall Street firms raised their outlooks for MRK: Goldman Sachs increased its price target to $160 and kept a Buy rating, while BMO raised its target to $170 and UBS lifted its target to $175. Morgan Stanley also upgraded the shares to Overweight with a $179 target after the cancer-trial success. Positive Sentiment: Investors see Merck’s newer products, acquired assets and pipeline programs as a potential growth cushion against Keytruda’s eventual patent expiration. The company’s expanding portfolio could help diversify revenue beyond its flagship drug. Can Merck’s New Drugs Offer Growth Cushion Ahead of Keytruda LOE? Neutral Sentiment: Unusually high options activity indicates heightened investor interest and potential volatility, but it does not by itself establish the direction of the stock. Negative Sentiment: RBC Capital Markets downgraded Merck to Sector Perform and set a $150 target, arguing that execution risks and the 2028 Keytruda loss of exclusivity are being underestimated. RBC said near-term catalysts are attractive, but the stock’s valuation leaves limited room for additional gains. Merck upgraded at Morgan Stanley after cancer trial win; RBC downgrades Negative Sentiment: Jefferies separately moved Merck from Strong Buy to Hold. The central concern is that the shares have already rallied substantially on the trial news, making the current valuation appear demanding relative to the remaining patent and execution risks. Insiders Place Their Bets In other Merck & Co., Inc. news, EVP Chirfi Guindo sold 10,000 shares of the firm’s stock in a transaction dated Thursday, August 13th. The shares were sold at an average price of $135.00, for a total value of $1,350,000.00. Following the completion of the sale, the executive vice president directly owned 36,613 shares in the company, valued at $4,942,755. This trade represents a 21.45% decrease in their ownership of the stock. The sale was disclosed in a filing with the SEC, which is available at this link. Also, EVP Richard R. Deluca sold 11,699 shares of Merck & Co., Inc. stock in a transaction that occurred on Wednesday, August 12th. The shares were sold at an average price of $131.63, for a total value of $1,539,939.37. Following the sale, the executive vice president directly owned 110,167 shares in the company, valued at approximately $14,501,282.21. The trade was a 9.60% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. Insiders have sold a total of 228,238 shares of company stock valued at $29,977,783 over the last quarter. 0.17% of the stock is owned by company insiders.

About Merck & Co., Inc. (Free Report)

Merck & Co, Inc is a global biopharmaceutical company engaged in the discovery, development, manufacture and marketing of prescription medicines, vaccines, biologic therapies and animal health products. Its portfolio spans multiple therapeutic areas with a particular emphasis on oncology, vaccines and infectious disease, as well as therapies for metabolic and chronic conditions. Among its well-known products are the cancer immunotherapy Keytruda (pembrolizumab) and the human papillomavirus vaccine Gardasil; the company also markets a range of medicines and vaccines for veterinary use through Merck Animal Health.

Founded in the late 19th century as the U.S.

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SHENZHEN, CHINA - JULY 27: In this photo illustration, a smartphone displays the logo of Merck & Co., Inc. (NYSE: MRK), a global pharmaceutical company developing medicines and vaccines, in front of a screen showing the company's latest stock market chart on July 27, 2026 in Shenzhen, Guangdong Province, China. (Photo illustration by Cheng Xin/Getty Images)

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This article was written by Doug Nathman, with research by his team at Trefis.

You wouldn’t anticipate a pharmaceutical powerhouse with a $368 billion market capitalization to produce results that leave growth investors feeling embarrassed. Nevertheless, in the past year, Merck (MRK) delivered an impressive 73% return to investors, outpacing the S&P 500. The peak occurred on August 19, 2026, when the stock reached unprecedented highs.

What triggered the recent surge? The direct catalyst was the successful clinical trial of the experimental mRNA cancer vaccine in collaboration with Moderna (MRNA). This achievement exhibited significant effectiveness, resulting in a notable increase in buying activity due to immediate revenue potential in oncology. However, yesterday's announcement merely confirms a larger strategy. The true factor driving the annual gain is how systematically Merck addressed the principal concern that has kept shareholders awake at night: What will transpire after the KEYTRUDA patent expiration?

For numerous years, the approaching loss of exclusivity for the blockbuster drug KEYTRUDA posed a substantial burden. The company’s leadership responded to this anxiety with a consistent stream of clinical and regulatory successes. The pipeline has produced concrete outcomes, transforming the company from one on the brink of a patent expiration to one that is constructing a dependable pathway for steady earnings growth.

What has the pipeline actually achieved?The pivotal event was the FDA's approval of LIPFENDRA. As the first oral PCSK9 inhibitor for individuals with high cholesterol, it disrupts a market that has been primarily reliant on injectables. Clinical evidence indicates that this daily pill can reduce LDL cholesterol by as much as 60% when used in conjunction with a statin. In addition to the recent mRNA cancer vaccine data, Merck also reported favorable Phase III results for sac-TMT in endometrial cancer and tulisokibart for ulcerative colitis. Growing uncertainties in the pipeline have been replaced by confirmed successes, demonstrating that the research engine continues to be highly productive.

How substantial is this new commercial plan?With clinical data solidifying, management has finally outlined future expectations. They estimate a pipeline with over $70 billion in commercial potential spread across more than 20 new products. For a market fixated on the forthcoming KEYTRUDA revenue gap, this figure serves as a compelling counter-narrative. The significant stock revaluation indicates that Wall Street now confidently endorses this projection.

Is the new valuation warranted when compared to competitors?Valuation serves as the ultimate test of this shift. All forward-looking peer valuations are based on consensus estimates for 2027 on an adjusted EPS basis. At $152 per share against anticipated adjusted earnings of $9.56, Merck is trading at a mere 16x forward earnings. When compared across the peer landscape, while Pfizer (PFE) is priced at a lowly 9.6x multiple and AbbVie (ABBV) at 16.4x, higher-growth competitors command significant premiums. Johnson & Johnson (JNJ) trades at 21.5x forward earnings, while Eli Lilly (LLY) commands 27x. Even with an over 73% rise in the past twelve months, Merck's 16x multiple underlines that the stock is still undervalued relative to top-tier competitors, suggesting more upside potential if they maintain performance.

Can Merck successfully market LIPFENDRA?Acquiring approval for a drug is one challenge, but achieving widespread prescriptions is quite another. The track record of injectable PCSK9 inhibitors has been marked by slow adoption rates, particularly within primary care environments. Analysts are scrutinizing the speed of initial access and whether a significant outcomes trial will act as the commercial turning point. Merck is betting vigorously on total market expansion rather than merely capturing existing market share.

Has the sales strategy been validated?The risks of clinical development have largely diminished, replaced by the less predictable risks associated with global commercial execution. The foundational science behind the mRNA cancer vaccine has been validated by late-stage clinical findings, while the broader pipeline continues to receive formal approvals from regulators. Now, the company must flawlessly execute its commercialization strategy to substantiate the new valuation.

The Final AssessmentInvestors should consider Merck not merely as a company facing a looming patent expiration, but rather as a de-risked commercial leader with clear visibility into its pipeline. In our opinion, Merck remains fundamentally undervalued at 16x 2027 adjusted earnings compared to its peer group, presenting an appealing risk-reward profile as operational execution unfolds.

The Trefis High Quality (HQ) Portfolio uses a rules-based methodology to select and systematically rebalance 30 stocks screened for operational quality and valuation metrics. This strategy evaluates companies across a broad market universe and measures its historical performance against a composite benchmark of the S&P 500, S&P Mid-Cap, and Russell 2000 indices.

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

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

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

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

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

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

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

Zdroj: Bloomberg

Michal Bárta
Fio banka, a.s.
Prohlášení

Key Takeaways Keytruda accounted for more than 55% of Merck's pharmaceutical sales in the first half of 2026.Keytruda posted $16.40 billion in first-half 2026 sales, fueled by global demand across cancer settings.Merck is pursuing new Keytruda combinations as patent loss and biosimilar competition loom.
Merck’s (MRK - Free Report) strong foothold in the oncology space is backed by its biggest revenue driver, Keytruda. The blockbuster PD-L1 inhibitor alone accounts for more than 55% of the company’s total pharmaceutical sales.

In the United States, Keytruda is approved for 44 indications spanning 19 tumor types, along with two tumor-agnostic approvals as well as for many of these indications worldwide. Notably, more than 2,800 clinical studies are currently evaluating Keytruda across multiple cancer types and treatment settings.

Keytruda, approved for several types of cancers, has played an instrumental role in driving Merck’s steady revenue growth over the past few years. The drug recorded sales worth $16.40 billion in the first half of 2026, up almost 4.2% year over year. Keytruda Qlex, the subcutaneous formulation of Keytruda, contributed $590 million during this period. Keytruda Qlex can offer substantially quicker administration time than the intravenous infusion of Keytruda.

Keytruda sales are being driven by strong global uptake in earlier-stage indications and higher global demand in metastatic indications. Importantly, management expects the growth to continue till Keytruda loses patent exclusivity in 2028.

We expect Keytruda to remain a key revenue driver for the company in the second half of 2026, along with the Animal Health business and new product launches. Recent label expansions, including Keytruda’s use in combination with Pfizer’s Padcev in muscle-invasive bladder cancer, have broadened its patient base and should support sales growth.

However, Keytruda is expected to face significant biosimilar competition around 2028-2029. Once biosimilars enter, Keytruda’s sales are likely to decline sharply.

With Keytruda set to face patent loss in 2028, Merck is working on different strategies to drive the drug’s long-term growth. These include innovative immuno-oncology combinations, including Keytruda with LAG3 and CTLA-4 inhibitors.

In the next few years, competitive pressure might increase for Keytruda from dual PD-1/VEGF inhibitors that inhibit both the PD-1 pathway and the VEGF pathway at once. They are designed to overcome the limitations of single-target therapies like Keytruda.

PD-L1 Inhibitors Competing With MRK's KeytrudaKeytruda faces competition from other PD-L1 inhibitors, including Bristol Myers’ (BMY - Free Report) Opdivo, Roche’s (RHHBY - Free Report) Tecentriq and AstraZeneca’s (AZN - Free Report) Imfinzi.

BMY’s Opdivo, like Keytruda, is approved across multiple cancer types, including lung, melanoma and kidney cancers. Bristol Myers recorded $4.63 billion in Opdivo sales in the first half of 2026, down 3.9% year over year.

Tecentriq is Roche’s leading immuno-oncology drug approved for multiple cancer indications. RHHBY recorded CHF 1.70 billion in Tecentriq sales in the first half of 2026, up 6% year over year.

AZN’s Imfinzi generated sales of $3.55 billion in the first half of 2026, up 29%, driven by strong demand growth across all regions from established indications and new launches. Imfinzi has strategically expanded its use across multiple cancer indications, strengthening AstraZeneca’s oncology portfolio.

MRK's Price Performance, Valuation and EstimatesYear to date, shares of Merck have rallied 28.1% compared with the industry’s 14.3% rise. The stock has also outperformed the sector and the S&P 500 during the same time frame, as seen in the chart below.

Image Source: Zacks Investment Research

From a valuation standpoint, Merck appears to be trading at a premium compared to the industry. Going by the price/earnings ratio, MRK’s shares currently trade at 18.92 forward earnings, higher than 18.73 for the industry. The stock is also trading above its 5-year mean of 12.86.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 earnings per share has declined from $3.76 to $3.25 while the same for 2027 has declined from $9.85 to $9.67 over the past 30 days.

Image Source: Zacks Investment Research

MRK's Zacks RankMerck currently has a Zacks Rank #4 (Sell).

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

Merck (MRK - Free Report) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to earnings of $2.13 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +50.00%. A quarter ago, it was expected that this pharmaceutical company would post a loss of $1.51 per share when it actually produced a loss of $1.28, delivering a surprise of +15.23%.

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

Merck, which belongs to the Zacks Large Cap Pharmaceuticals industry, posted revenues of $16.61 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.69%. This compares to year-ago revenues of $15.81 billion. The company has topped consensus revenue estimates four times over the last four quarters.

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

Merck shares have added about 21.4% since the beginning of the year versus the S&P 500's gain of 11%.

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

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

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

Ahead of this earnings release, the estimate revisions trend for Merck was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.34 on $17.5 billion in revenues for the coming quarter and $2.74 on $66.77 billion in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Large Cap Pharmaceuticals is currently in the bottom 7% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

Innoviva (INVA - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026.

This biopharmaceutical company is expected to post quarterly earnings of $0.56 per share in its upcoming report, which represents a year-over-year change of -27.3%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Innoviva's revenues are expected to be $113.22 million, up 12.9% from the year-ago quarter.

Amylyx Stock: Why the Full Pipeline Story MattersMerck & Co., Inc. NYSE: MRK outlined its HIV treatment and prevention strategy at an investor event following the International AIDS Conference, highlighting Phase III results for a once-weekly oral HIV regimen and its plans for a monthly oral pre-exposure prophylaxis, or PrEP, candidate.

Company executives said Merck’s pipeline is focused on reducing treatment burden for people living with HIV and expanding prevention options for people at risk of infection. The company cited the continuing need for alternatives to daily pills and injectable regimens, particularly as patients age and manage comorbidities and multiple medications.

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Weekly Treatment Data Merck Just Made a Big Bet on a New Cancer Growth Engine Dr. Liz Rhee, Merck’s vice president of clinical research for infectious diseases, presented results from the Phase III ISLEND-1 and ISLEND-2 trials of once-weekly oral islatravir plus lenacapavir, a regimen being developed with Gilead Sciences.

ISLEND-1 was a double-blinded global study involving 607 virologically suppressed adults. The weekly two-drug regimen was compared with daily bictegravir/emtricitabine/tenofovir alafenamide, or B/F/TAF. Rhee said islatravir plus lenacapavir achieved non-inferior efficacy at 48 weeks, with viral suppression rates above 90% and no treatment-emergent resistance to either drug.

3 Undervalued Names Too Cheap to IgnoreIn the open-label ISLEND-2 study, 626 participants were randomized to receive the weekly regimen or a range of daily standard-of-care therapies. The weekly regimen also demonstrated non-inferior efficacy, while viral suppression remained approximately 95%, according to Rhee. Participants reported greater satisfaction and less treatment burden with the weekly regimen than with their prior daily therapies.

Across both studies, Rhee said the regimen was generally well tolerated, with safety comparable to the control regimens. Merck reported no clinically meaningful changes in lymphocyte counts, CD4 counts, or body weight, and said no participants discontinued treatment because of declining CD4 or absolute lymphocyte counts.

Chief Medical Officer Eliav Barr addressed a question regarding a small statistical difference in CD4-count changes in ISLEND-2. Barr said Merck did not consider the finding clinically meaningful, citing a baseline imbalance and the absence of a similar pattern in ISLEND-1 or the company’s Phase II islatravir/ulonivirine study. He said the company viewed the result as likely reflecting regression to the mean.

Merck said it plans to submit islatravir plus lenacapavir to global regulatory authorities. Under the collaboration, Gilead will lead U.S. commercialization of the long-acting oral program, while Merck will lead commercialization outside the United States. The companies will share global development and commercialization costs on a 60/40 basis, respectively, and will split global product revenue equally up to approximately $2 billion, after which Gilead will receive 65% and Merck 35%.

Second Weekly Program Moving Toward Phase III Merck also discussed islatravir plus ulonivirine, its wholly owned investigational weekly oral regimen. The company reported that a Phase IIb trial showed the regimen maintained viral suppression through week 24, with no participants in the treatment group recording HIV RNA of 50 copies per milliliter or greater. More than 94% of participants remained virally suppressed, and Merck reported no treatment-emergent resistance cases.

Rhee said the regimen was generally well tolerated and had an adverse-event profile comparable to daily B/F/TAF. Merck plans to advance the program into the SYMPHORIA Phase III program, including trials in virologically suppressed adults switching from daily treatment and in treatment-naive adults. SYMPHORIA 1 and 2 are expected to begin in the first half of 2027, while results from the Phase II component of SYMPHORIA 3 are anticipated in the first half of 2027.

The company said both weekly regimens were designed with approximately a seven-day “forgiveness” window for missed doses.

Monthly Oral PrEP Program Merck also highlighted alimatravir, its investigational once-monthly oral PrEP candidate. The company said the 11-milligram dose is expected to provide protective drug levels within one hour, without a loading dose. Merck said Phase III EXPrESSIVE 10 and 11 trials are expected to report results in 2027.

Executives positioned the monthly oral approach as a potentially discreet alternative that does not require healthcare-provider administration. Rhee said the dose also provides approximately one week of forgiveness if a monthly dose is missed.

Merck recently announced plans, contingent on approval, to support access to alimatravir in low- and middle-income countries through voluntary licensing agreements covering more than 129 countries, regional manufacturing support, and investments intended to facilitate access following approval.

Commercial Outlook Brian Foard, executive vice president and president of Merck’s Specialty, Pharma and Infectious Diseases Business Unit, said the company sees a non-risk-adjusted HIV opportunity exceeding $5 billion by the mid-2030s across its marketed and investigational portfolio. That portfolio includes IDVYNSO, Merck’s newly approved daily oral treatment, the two weekly treatment programs, and alimatravir.

Foard said Merck estimates the HIV treatment market was about $26 billion in 2025 and could grow to roughly $32 billion by the mid-2030s. He said the PrEP market, estimated at about $4 billion currently, could more than double over time. Gregg Szabo, head of Merck’s global HIV franchise, said the company expects long-acting regimens to represent a substantial share of the treatment market over time and sees weekly oral options potentially reaching about one-third of the overall treatment market.

About Merck & Co., Inc. (NYSE:MRK)Merck & Co, Inc is a global biopharmaceutical company engaged in the discovery, development, manufacture and marketing of prescription medicines, vaccines, biologic therapies and animal health products. Its portfolio spans multiple therapeutic areas with a particular emphasis on oncology, vaccines and infectious disease, as well as therapies for metabolic and chronic conditions. Among its well-known products are the cancer immunotherapy Keytruda (pembrolizumab) and the human papillomavirus vaccine Gardasil; the company also markets a range of medicines and vaccines for veterinary use through Merck Animal Health.

Founded in the late 19th century as the U.S.

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

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Item 1 of 2 A vial and syringe are seen in front of Merck logo in this illustration taken March 26, 2025. REUTERS/Dado Ruvic/Illustration/File Photo

[1/2]A vial and syringe are seen in front of Merck logo in this illustration taken March 26, 2025. REUTERS/Dado Ruvic/Illustration/File Photo Purchase Licensing Rights, opens new tab

SummaryCompaniesCEPI backs effort with up to $8.5 million in fundingHilleman aims to make finished doses for early-stage trials using IAVI starting materialPartners would transfer technology to a large-scale manufacturer if early trials succeedOther vaccine candidates also being fundedCHICAGO, July 30 (Reuters) - Hilleman Laboratories, ​a Singapore-based joint venture between Merck (MRK.N), opens new tab and the global charity Wellcome, is gearing up to manufacture doses of a ‌promising experimental vaccine against the rare Bundibugyo strain of Ebola responsible for a fast-spreading outbreak in the Democratic Republic of Congo.

The effort is backed by up to $8.5 million in funding from the global partnership Coalition for Epidemic Preparedness Innovations, or CEPI, those involved in the effort said on Thursday.

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"With Bundibugyo ​virus cases rising at worrying speed, the epidemic is fast becoming a humanitarian crisis,” CEPI Chief Executive Richard Hatchett said ​in a statement.

“No vaccine is currently approved against the virus, so we are urgently advancing vaccine candidates ⁠into testing," he said.

As of July 29, the outbreak in the eastern Congo has infected 3,360 people and killed 1,487. There ​are also no approved treatments for Bundibugyo Ebola.

CEPI has said it is investing up to $8.6 million for the development of a separate Bundibugyo vaccine ​candidate from the University of Oxford, which began a first human trial earlier this month.

The vaccine is based on ChAdOx1 technology, which was used in the Oxford/AstraZeneca (AZN.L), opens new tab COVID-19 vaccine, and is being manufactured by the Serum Institute of India.

CEPI also committed up to $50 million to develop a Bundibugyo Ebola vaccine with Moderna (MRNA.O), opens new tab.

The Merck/Wellcome ​collaboration will advance manufacturing of a single-dose vaccine developed by the International AIDS Vaccine Initiative, which the World Health Organization in ​May singled out as the most promising candidate.

The vaccine uses the same recombinant vesicular stomatitis virus, or rVSV, platform used by Merck for its approved ‌Ervebo ⁠Ebola vaccine that targets the more common Zaire strain.

Hilleman will use starting material generated by IAVI to create finished doses that can be used in early-stage trials. Merck will serve as a technical adviser and contribute scientific and manufacturing expertise on the rVSV platform, the company said.

Doses could be ready for clinical testing by the end of this year, Tarit Mukhopadhyay, Merck's head of infectious disease and ​vaccines discovery, said in an interview.

Merck ​and CEPI earlier this year ⁠partnered on a $30 million program to update the manufacturing processes of Ervebo aimed at improving affordability and access for low- and middle-income countries by increasing yield and extending its shelf life.

Hilleman Labs is equipped ​to make tens of thousands of doses, which should be plenty of supply for testing, Mukhopadhyay ​said. Should larger-scale ⁠production be needed, the partners have agreed to transfer the vaccine technology to a larger-scale manufacturer.

"None of those plans have been solidified," Mukhopadhyay said.

“We urgently need to strengthen our toolkit against Bundibugyo. The outbreak is in a region faced with conflict, instability, and strained resources, making a ⁠holistic response ​essential,” said Charlie Weller, head of vaccines at Wellcome.

Beyond vaccine testing, treatment trials are ​underway testing Mapp Biopharmaceuticals' pan-Ebola virus antibody drug called MBP134, and Gilead Sciences' (GILD.O), opens new tab antiviral remdesivir, alone and in combination.

The WHO is also considering trials of Regeneron's (REGN.O), opens new tab antibody ​drug maftivimab in combination with two other antibodies, and Gilead's oral antiviral drug obeldesivir.

Reporting by Julie Steenhuysen in Chicago; Editing by Bill Berkrot

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

Key Takeaways Merck's Q2 results on Aug. 4 will spotlight Keytruda, with consensus estimating sales at $8.06 billion.MRK expects continued demand across earlier-stage and metastatic cancers, plus higher Qlex contributions.MRK is expected to discuss long-term growth plans as Keytruda faces patent expiry and biosimilar competition. Merck’s (MRK - Free Report) blockbuster PD-1 inhibitor, Keytruda, approved for several types of cancer, is its key top-line driver, accounting for around 55% of the company’s pharmaceutical sales. Keytruda now holds more than 40 FDA-approved indications spanning 19 tumor types.

The drug has played an instrumental role in driving Merck’s steady revenue growth over the past few years. Keytruda is expected to remain Merck's primary growth driver in the second quarter of 2026. Investors will look out for Keytruda’s sales number when Merck announces second-quarter results on Aug. 4.

The Zacks Consensus Estimate for Keytruda’s sales is $8.06 billion. Keytruda is expected to continue delivering double-digit year-over-year growth in the second quarter. Its sales are likely to have been driven by strong demand across earlier-stage indications globally and continued strong momentum in metastatic indications. A favorable timing of wholesaler purchases benefited Keytruda’s sales in the first quarter, which is likely to be absent in the second.

Keytruda Qlex, the recently launched subcutaneous formulation of Keytruda, is also gradually contributing incremental sales. It added $128 million to Keytruda’s sales in the first quarter and the contribution is expected to be higher in the second.

Last quarter, Merck said that it was seeing an increase in usage of Keytruda in tumors that primarily affect women, including cervical, breast and endometrial cancers, as well as Keytruda in combination with Pfizer’s antibody drug conjugate, Padcev, in first-line, locally advanced or metastatic urothelial cancer. An update is expected on the upcoming conference call.

The company expects Keytruda’s growth to continue till it loses patent exclusivity in 2028. Keytruda’s core U.S. patent is expected to expire around 2028, with additional patents expiring slightly after that. Keytruda is expected to face significant biosimilar competition around 2028-2029. Once biosimilars enter, Keytruda’s sales are likely to decline sharply. Investors will also look for management commentary on long-term growth and Merck's strategy to offset Keytruda's LOE impact.

Key Competitors of Merck’s KeytrudaThe closest and most direct competitor to Keytruda is Bristol Myers’ (BMY - Free Report) Opdivo, another PD-1 inhibitor. Like Keytruda, Opdivo is approved across multiple tumor types, including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, bladder cancer and gastrointestinal cancers. Bristol Myers has strengthened Opdivo's competitive position through combination regimens such as Opdivo + Yervoy (ipilimumab) and newer fixed-dose combinations. Opdivo generated sales of $2.15 billion in the first quarter of 2026, down 5% year over year.

Another major competitor is AstraZeneca's (AZN - Free Report) PD-L1 inhibitor, Imfinzi, particularly in lung cancer. AstraZeneca’s Imfinzi generated sales of $1.69 billion in the first quarter of 2026, up 30% year over year.

Roche (RHHBY - Free Report) markets Tecentriq, another PD-L1 inhibitor competing with Keytruda in NSCLC, bladder cancer, liver cancer and certain breast cancers.

The longer-term competitive threat to Keytruda comes from dual PD-1/VEGF inhibitors that inhibit both the PD-1 pathway and the VEGF pathway at once. They are designed to overcome the limitations of single-target therapies like Keytruda. One of the most closely watched dual PD-1/VEGF inhibitor is Summit Therapeutics' ivonescimab, which it has licensed from Akeso.

MRK’s Price Performance, Valuation and EstimatesMerck’s stock has risen 21.7% so far this year compared with an increase of 10.5% for the industry.

Image Source: Zacks Investment Research

From a valuation standpoint, Merck is slightly expensive. Going by the price/earnings ratio, Merck’s shares currently trade at 19.04 forward earnings, higher than 18.49 for the industry as well as the stock’s five-year mean of 12.83.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 earnings has declined from $4.57 per share to $2.74 per share, while that for 2027 has declined from $9.81 per share to $9.72 per share over the past 30 days.

Image Source: Zacks Investment Research

Merck has a Zacks Rank #4 (Sell) at present.

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

Phase 3 Trial Meets Primary Progression-Free Survival GoalThe trial met its primary endpoint of progression-free survival (PFS) for mismatch repair-deficient (dMMR) advanced or recurrent endometrial cancer patients who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy.

Keytruda is the first and only PD-1 inhibitor to show a statistically significant and clinically meaningful improvement in PFS as monotherapy compared to platinum doublet chemotherapy for these patients in a Phase 3 trial.

At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for Keytruda.

However, these OS data were not mature at the time of this analysis.

Overall Survival Data Continue To MatureThe trial is ongoing, and OS for the full study population will be evaluated at a future analysis. The analysis also showed a clinically meaningful overall response rate (ORR), as well as complete response rate (CRR) and duration of response (DOR) for Keytruda.

The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

In the U.S., Keytruda is the only anti-PD-1 therapy with three approved indications for patients with certain types of endometrial cancer.

Last week, the U.S. Food and Drug Administration (FDA) approved Merck’s Keytruda and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment. Then it continued after cystectomy as adjuvant treatment for muscle-invasive bladder cancer (MIBC).

These approvals represent the first and only PD-1 inhibitor plus antibody-drug conjugate regimens approved for adults with MIBC regardless of cisplatin eligibility.

MRK Price Action: Merck & Co shares were up 2.43% at $123.71 at the time of publication on Wednesday, according to Benzinga Pro data.

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Agreement will help state ADAP programs provide access to IDVYNSO™ (doravirine/islatravir) for eligible individuals

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced an agreement with the ADAP Crisis Task Force (ACTF) to help state AIDS Drug Assistance Programs (ADAPs) provide access to the company’s new once-daily HIV treatment, IDVYNSO™ (doravirine/islatravir). In 2024, state ADAPs supported more than 250,000 people with HIV in the United States.

IDVYNSO was approved by the U.S. Food and Drug Administration (FDA) in April 2026 as a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

“ADAP programs play a critical role in supporting access to treatment for people living with HIV who are uninsured or underserved,” said Tim Horn, Director, Medication Access, National Alliance of State and Territorial AIDS Directors (NASTAD). “We appreciate Merck’s continued engagement and its willingness to work collaboratively to help address the critical access challenges facing state ADAP programs.”

“Merck is pleased to have reached this agreement with the ADAP Crisis Task Force to expand access to IDVYNSO for eligible people with HIV,” said Conrod Kelly, U.S. HIV business unit head, Merck. “This agreement reflects our long-standing commitment to working with the ACTF, state ADAPs and the HIV community to strengthen access and help address persistent gaps in care.”

For individuals with questions about coverage and affordability, the Merck Access Program may be able to provide information about insurance benefits, estimated out-of-pocket costs and co-pay assistance options for eligible patients.

The Merck Access Program for IDVYNSO

Merck offers support to individuals who are prescribed IDVYNSO, including information about patient insurance coverage and out-of-pocket costs, co-pay assistance for eligible, commercially insured individuals, and how individuals may access IDVYNSO through The Merck Access Program. For additional information, healthcare providers and individuals can call 1-877-709-4455 or visit https://www.merckaccessprogram-idvynso.com/.

About IDVYNSO

IDVYNSO is a fixed-dose combination of two medicines, doravirine and islatravir. Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase. Islatravir is a potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms including:

inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination). Selected Safety Information for IDVYNSO

Contraindications

IDVYNSO is contraindicated when co-administered with:

drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of IDVYNSO. lamivudine (3TC) or emtricitabine (FTC) as significant decreases in islatravir-triphosphate (ISL-TP) concentrations may occur, which may decrease the effectiveness of IDVYNSO. (See Drug Interactions) Warnings and Precautions

Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during postmarketing experience with doravirine-containing regimens. In addition, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) was reported with IDVYNSO in a clinical trial. Discontinue IDVYNSO, and other medications associated with these reactions, immediately if a painful rash with mucosal involvement, a progressive severe rash, or a rash with constitutional symptoms, eosinophilia, lymphadenopathy, or other organ involvement develops. Close clinical monitoring, and appropriate therapy should be initiated.

The concomitant use of IDVYNSO and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to loss of therapeutic effect of IDVYNSO and possible development of resistance or possible clinically significant adverse reactions from greater exposures of a component of IDVYNSO.

Consider the potential for drug interactions prior to and during IDVYNSO therapy, review concomitant medications during IDVYNSO therapy, and monitor for adverse reactions. (See Drug Interactions)

Adverse Reactions

The most common adverse reactions (incidence ≥ 2%, all grades in any treatment group) reported in virologically suppressed participants in the IDVYNSO treatment groups in Trials 051 and 052, respectively, were: diarrhea (3% and 1%), dizziness (2% and 1%), fatigue (2% and 1%), abdominal distension (2% and 1%), headache (2% and 1%) and weight increased (2% and <1%).

A single case of severe immune thrombocytopenia (platelet count nadir of 2 x109/L) characterized by abrupt onset of subcutaneous hematoma, petechiae, and hematuria was reported in a participant 32 days after initiating IDVYNSO. The case resolved with discontinuation of IDVYNSO, in conjunction with treatments including corticosteroids and intravenous immunoglobulin (IVIG). Among all participants in Trials 052 and 051, there were no patterns of platelet decreases over time with IDVYNSO and no differences between treatment arms in mean change from baseline in platelet count.

Drug Interactions

IDVYNSO is a complete regimen; co-administration with other antiretroviral medications for treatment of HIV-1 infection is not recommended.

Co-administration of IDVYNSO with a CYP3A inducer decreases doravirine plasma concentrations, which may reduce the efficacy of IDVYNSO. If IDVYNSO is co-administered with rifabutin, one tablet of doravirine should be taken approximately 12 hours after the dose of IDVYNSO. Co-administration of IDVYNSO with other moderate CYP3A inducers is not recommended.

Co-administration of IDVYNSO and drugs that are inhibitors of CYP3A may result in increased plasma concentrations of doravirine.

Co-administration of IDVYNSO is not recommended with deoxycytidine kinase (dCK) substrates (e.g., nucleoside antimetabolites) as they may reduce the exposure of islatravir-triphosphate or with adenosine deaminase (ADA) inhibitors (e.g., pentostatin) as they may increase the exposure of islatravir. (see Contraindications)

Use in Specific Populations

There are insufficient human data on the use of IDVYNSO during pregnancy to inform a drug-associated risk of birth defects and miscarriage. Healthcare providers are encouraged to call the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263 to report pregnancy outcomes in individuals exposed to IDVYNSO.

It is unknown whether IDVYNSO or any of its components are present in human milk, affects human milk production, or has effects on the breastfed infant. Inform patients that the potential risks of breastfeeding include: (1) HIV-1 transmission (in infants without HIV-1), (2) developing viral resistance (in infants with HIV-1), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults.

Clinical trials in virologically suppressed participants who received IDVYNSO included 81 (11%) participants aged 65 years and older, including 10 (1%) aged 75 years and older. Overall differences in response have not been identified between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

No dosage adjustment of IDVYNSO is required in patients with eGFR ≥30 mL/min/1.73 m2. IDVYNSO is not recommended in patients with eGFR <30 mL/min/1.73 m2 and has not been studied in participants undergoing dialysis.

No dosage adjustment of IDVYNSO is recommended in patients with mild or moderate hepatic impairment (Child- Pugh Class A or B). IDVYNSO has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and therefore is not recommended in these patients.

IDVYNSO does not have activity against hepatitis B virus (HBV). Patients with HBV coinfection who switch to IDVYNSO from an antiretroviral regimen with activity against HBV, and patients on IDVYNSO who are newly diagnosed with HBV coinfection, should be closely monitored and specific anti-HBV therapy should be considered, as clinically appropriate.

Merck’s Commitment to HIV

For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community and access initiatives aimed at helping to end the HIV epidemic for everyone.

About Islatravir (MK-8591) and Merck’s HIV Research

Islatravir (MK-8591) is Merck’s potent, next-generation nucleoside analog reverse transcriptase inhibitor (NRTI) that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination).

Islatravir is approved in combination with Merck’s NNRTI, doravirine, in the United States and Japan as IDVYNSO™, a once-daily, single-tablet regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.

Islatravir is also under evaluation in multiple ongoing early and late-stage clinical trials in combination with other antiretrovirals for potential once-weekly treatments for HIV-1, in Merck's proprietary two-drug regimens.

Islatravir in combination with Gilead’s lenacapavir is in Phase 3 development as a novel oral once-weekly treatment for HIV-1 [ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299)], and islatravir in combination with Merck’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) is in Phase 2b development (MK-8591B-060, NCT06891066 and MK-8591B-062, NCT07266831) as an oral once-weekly treatment.

MK-8527 is Merck’s investigational, novel, once-monthly, oral candidate for pre-exposure prophylaxis (PrEP) for HIV-1. In collaboration with the Gates Foundation, the Phase 3 EXPrESSIVE-10 trial (MK-8527-010, NCT07071623) trial is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among women and adolescent girls in sub-Saharan Africa. The Phase 3 EXPrESSIVE-11 trial (MK-8527-011, NCT07044297) in 16 countries is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among people likely to be exposed to HIV-1. Both trials are now enrolling.

For an overview of Merck’s HIV treatment and prevention clinical development program, please click here.

About Merck

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

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

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

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

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

Please see Prescribing Information for IDVYNSO™ (doravirine and islatravir) at https://www.merck.com/product/usa/pi_circulars/i/idvynso/idvynso_pi.pdf and Patient Information for IDVYNSO at https://www.merck.com/product/usa/pi_circulars/i/idvynso/idvynso_ppi.pdf.

More News From Merck & Co., Inc.