Merck & Co Option Alert: Sep 19 $90 Calls Sweep (5) near the Bid: 5250 vs 16221 OI; Earnings 7/29 Before Open 

Merck & Co Option Alert: Sep 19 $90 Calls Sweep (5) near the Bid: 5250 @ $1.45 vs 16221 OI; Earnings 7/29 Before Open Ref=$79.18

Merck & Co (NYSE:MRK) Bolsa

MERCK & CO. INC.

Merck & Co

Merck makes pharmaceutical products to treat several conditions in a number of therapeutic areas, including cardiometabolic disease, cancer, and infections. Within cancer, the firm's immuno-oncology platform is growing as a major contributor to overall sales. The company also has a substantial vaccine business, with treatments to prevent pediatric diseases as well as human papillomavirus, or HPV. Additionally, Merck sells animal health-related drugs. From a geographical perspective, just under half of the company's sales are generated in the United States.

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El mercado bursátil estadounidense tuvo una sesión mixta el martes. El Nasdaq Composite subió casi 80 puntos, o un 0,5%, y cerró en 18.271,86, mientras que el Dow Jones se mantuvo prácticamente sin cambios en 42.587,50. El S&amp;P 500 avanzó un 0,2% para finalizar en 5.776,65.

GameStop, FST Corp, Merck, UPS y Tesla: 5 acciones que están en el radar de los inversores

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The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Merck &amp; Co Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Enflonsia (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">their first RSV season</a>.
With a <a href="https://www.cdc.gov/media/releases/2025/2025-cdcs-advisory-committee-on-immunization-concludes-meeting-with-joint-statement.html" target="_blank" rel="noreferrer noopener">five-to-two </a>majority, RFK Jr.&#8217;s newly constituted committee made its first ruling. This body was formed after RFK Jr. entirely replaced the previous 17-member panel with his own selections.
The ACIP also voted to include Enflonsia in the Vaccines for Children Program, an essential step in ensuring broad access to this preventive <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46122920/acip-recommends-use-of-mercks-enflonsia-clesrovimab-cfor-for-prevention-of-respiratory-syncytial-v" rel="noreferrer noopener">option for infants</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/politics/25/06/46109624/rfk-jr-overhauls-cdc-vaccine-panel-sparking-expert-backlash-boycott-from-top-medical-group" rel="noreferrer noopener">RFK Jr. Overhauls CDC Vaccine Panel, Sparking Expert Backlash, Boycott From Top Medical Group</a>
Enflonsia is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid, and durable protection through 5 months, a typical RSV season, with the same dose regardless of weight.
A typical RSV season usually spans autumn to spring of the next year. The U.S. Food and Drug Administration (FDA) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b45846612/u-s-fda-approves-mercks-enflonsia-clesrovimab-cfor-for-prevention-of-respiratory-syncytial-virus-r" rel="noreferrer noopener">approved Enflonsia in June</a>.
The approval is based on results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of Enflonsia administered to preterm and full-term infants (birth to 1 year of age). The trial met its primary and key secondary endpoints.
Enflonsia demonstrated a reduction in incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring ≥1 indicator of lower respiratory infection (LRI) or severity compared to placebo through 5 months (primary endpoint) by 60.5% (incidence rates: Enflonsia, 0.026; placebo, 0.065).
Enflonsia demonstrated a reduction in RSV-associated hospitalizations through 5 months (key secondary endpoint) by 84.3% (incidence rates: Enflonsia, 0.004; placebo, 0.024), showing increasing efficacy with increasing disease severity.
Merck plans to make Enflonsia available for physicians and healthcare administrators to order in July 2025. Shipments will be delivered before the start of the 2025-2026 RSV season.
The ACIP&#8217;s recommendation for Enflonsia is provisional and will become official once it is reviewed and finalized by the CDC Director or the Health and Human Services Secretary (in the absence of a CDC Director).
Price Action: MRK stock is up 0.33% at $79.10 during the premarket session at last check Friday.
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RFK Jr's CDC Panel Recommends Merck's RSV Shot For Infants

After years of struggling with market share losses and uneven execution, Elanco Animal Health Incorporated (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ELAN#NYSE">ELAN</a>) appears to be <a href="https://www.benzinga.com/general/health-care/25/05/45208077/elanco-animal-health-sells-xdemvy-royalties-to-blackstone-in-295-million-deal-to-lower-debt">turning a corner</a>. 
What Happened: Investor meetings hosted by William Blair this week gave analysts enough confidence to upgrade the stock, citing a stabilized core business and promising momentum in its innovation pipeline. With new product launches in both livestock and pet health, Elanco is better positioned for growth—though it still faces stiff competition from larger rivals like Zoetis and Merck.
Analyst Brandon Vazquez said meetings and conversations centered on current momentum <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">and pipeline efforts</a>, giving the confidence to upgrade.
The analyst highlights that the core business (ex-innovation, or about 85% of sales) has stabilized due to improved execution or, bluntly, years of share losses that have made less competitive segments less impactful to the P&amp;L statement.
Also Read: <a href="https://www.benzinga.com/25/05/45257358/animal-health-elanco-sees-momentum-building-despite-challenging-market-backdrop-q1-earnings-beat-estimates" target="_blank" rel="noreferrer noopener">Animal Health Elanco Chirps A Solid Quarter Tempered By Soft Q2 EPS Guide</a>
The company&#8217;s growing lineup of recent launches may also help drive sales of older products over time, Vazquez says.
Why It Matters: These products alone could contribute around five percentage points to overall growth in 2025. William Blair upgraded Elanco&#8217;s rating from <a href="https://www.benzinga.com/quote/ELAN/analyst-ratings" target="_blank" rel="noreferrer noopener">Market Perform to Outperform</a>.
Recently, the European Medicines Agency&#8217;s Committee for Veterinary Medicinal Products granted a positive opinion to Elanco&#8217;s Zenrelia (ilunocitinib). The company expects approval and product supply in the market before the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/n45914288/elanco-receives-positive-opinion-on-zenrelia-ilunocitinib-from-eus-committee-for-veterinary-medici" rel="noreferrer noopener">end of the third quarter</a>.
The management noted that when new customers start using newer farm animal products like Bovaer and Experior—which currently face little to no competition—it can also increase demand for older products like Rumensin.
William notes that Elanco faces tough competition from big, well-funded companies that are also investing heavily in developing new products.
Competition: Merck &amp; Co Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) JAK inhibitor could affect how well Elanco's drug Zenrelia performs globally. Merck's drug is expected to have fewer safety concerns.
Zoetis Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ZTS#NYSE">ZTS</a>) also has a strong track record of improving existing products, analysts say. That could make it harder for Elanco's new drugs to gain market share.
Price Action: ELAN stock is up 3.05% at $14.18 at the last check on Thursday.
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Elanco Animal Health Gets Its Bite Back, Pipeline Efforts Earn Praise

ENFLONSIA is the first and only RSV preventive option for administration to infants using the same dose regardless of weight
Ordering will begin in July, with shipments delivered before the start of the 2025-2026 RSV season
Merck (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), known as MSD outside of the United States and Canada, today announced the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend ENFLONSIA&#x2122; (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season. The ACIP also voted to include ENFLONSIA in the Vaccines for Children Program—an important step in ensuring broad access to this preventive option for infants.
ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same dose regardless of weight. A typical RSV season usually spans autumn to spring of the next year.
ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA.
The U.S. Food and Drug Administration (FDA) <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fu-s-fda-approves-mercks-enflonsia-clesrovimab-cfor-for-prevention-of-respiratory-syncytial-virus-rsv-lower-respiratory-tract-disease-in-infants-born-during-or-entering-their-fir%2F&amp;esheet=54282813&amp;newsitemid=20250626825962&amp;lan=en-US&amp;anchor=approved&amp;index=1&amp;md5=1cf4781dff86794fbb9b489189f8d701">approved</a> ENFLONSIA earlier this month based on clinical data from the Phase 2b/3 CLEVER and Phase 3 SMART trials. Merck plans to make ENFLONSIA available for ordering by physicians and health care administrators in July 2025, with shipments to be delivered before the start of the 2025-2026 RSV season.
The ACIP's recommendation for ENFLONSIA is provisional and will be official once reviewed and finalized by the CDC Director or the Health and Human Services Secretary (in the absence of a CDC Director).

U.S. CDC ACIP Recommends Use Of Merck's ENFLONSIA For Prevention Of RSV Lower Respiratory Tract Disease In Infants Younger Than 8 Months Of Age Born During Or Entering Their First RSV Season

<a href="https://www.youtube.com/watch?v=z-16fImZoEc">https://www.youtube.com/watch?v=z-16fImZoEc</a>
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U.S. CDC Advisory Panel Votes 5-1 In Favor Of Children 18 Years & Younger Receiving Seasonal Flu Vaccine Only In Single Dose Forms That Are Free From Thimerosal; Of Pregnant Women Receiving Seasonal Flu Vaccine Only In Single Dose Forms That Are Free From Thimerosal; Of All Adults Receiving Seasonal Flu Shot Only In Single Dose Forms That Are Free From Thimerosal

U.S. CDC Vaccine Advisory Panel Votes 7-0 In Favor Of Adding Preventive RSV Therapies To Vaccines For Children Resolution

<a href="https://www.youtube.com/watch?v=z-16fImZoEc" title="https://www.youtube.com/watch?v=z-16fImZoEc">https://www.youtube.com/watch?v=z-16fImZoEc</a>

U.S. CDC Vaccine Advisory Panel Votes 5-2 In Favor Of Merck's RSV Antibody Drug For Infants 8 Months Or Younger

Health Secretary Robert F. Kennedy Jr.'s newly reconstituted vaccine advisory panel is facing criticism from medical experts and former federal officials after its first meeting strayed sharply from established scientific review norms.
What Happened: On Wednesday, the Advisory Committee on Immunization Practices reconvened under controversy, just weeks after Kennedy dismissed all 17 previous members of the committee and replaced them with his appointees, according to Reuters.
Criticism has since intensified after the panel&#8217;s agenda was abruptly changed only one day before the meeting, while adding a presentation on thimerosal, a vaccine preservative whose alleged risks have been repeatedly debunked by mainstream science. 
The presentation was delivered by Lyn Redwood, former leader of Children&#8217;s Health Defense, an anti-vaccine organization originally founded by Kennedy himself.
The reconstituted panel is already seeing a fallout, with Dr. Michael Ross, one of the newly appointed members, resigning unexpectedly before the first meeting was held. Two other Centers for Disease Control and Prevention staff members also left amid the chaos.
At least half of Kennedy&#8217;s appointees have publicly questioned vaccine safety in the past, leading organizations such as the American Academy of Pediatrics, a non-voting participant of these meetings, to skip, citing a lack of scientific credibility and procedural transparency. The organization plans to publish its evidence-based childhood vaccine schedules instead.
The panel&#8217;s chair, Dr. Martin Kulldorff, stated that the committee would review individual vaccines, as well as the cumulative effects and scheduling of childhood immunizations.
The committee also postponed a key vote on an RSV vaccine intended for children, further heightening uncertainty around upcoming vaccine recommendations.
Why It Matters: The overhaul of the CDC's vaccine schedules stands to have a significant impact on pharma companies, especially those with exposure to childhood vaccines. 
For instance, Pfizer Inc. and Moderna Inc., with their Respiratory Syncytial Virus (RSV) vaccines, stand to see some headwinds due to the committee postponing its vote on the vaccine.
Similarly, Merck &amp; Co. Inc., having reported $540 million in revenue during its <a href="https://www.benzinga.com/general/biotech/25/04/44983460/mercks-q1-earnings-beat-wall-street-adjusts-2025-profit-outlook-as-tariffs-may-result-in-incremental-cost-of-200-million">first quarter results</a> from its <a href="https://www.benzinga.com/trading-ideas/long-ideas/19/04/13514693/nyc-mandates-measles-vaccinations-merck-is-the-exclusive-manufacturer">measles-mumps-rubella (MMR) vaccine</a> series, could see a material impact as a result of the vaccine advisory committee&#8217;s stance.
<figure class="wp-block-table"> 
<table class="has-fixed-layout">
<thead>
<tr>
<th>Company</th>
<th>Potential Impact</th>
<th class="has-text-align-center" data-align="center">YTD Performance</th>
</tr>
</thead>
<tbody>
<tr>
<td>Merck &amp; Co Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)</td>
<td>Outsized exposure to childhood vaccination schedules, with its MMR series.</td>
<td class="has-text-align-center" data-align="center">-19.66%</td>
</tr>
<tr>
<td>Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)</td>
<td>Delays in the approval of its RSV vaccines</td>
<td class="has-text-align-center" data-align="center">-8.83%</td>
</tr>
<tr>
<td>Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>)</td>
<td>RSV vaccine delays, along with the dropped COVID-19 vaccine mandate for pregnant women.</td>
<td class="has-text-align-center" data-align="center">-36.05%</td>
</tr>
</tbody>
</table>
</figure>
Price Action: Merck shares were down 0.81% on Wednesday, trading at $79.67, with the stock trading up 0.04% after hours.
<figure class="wp-block-image size-large"><a href="https://www.benzinga.com/premium/ideas/benzinga-edge-2#:~:text=Turn%20Market%20Chaos,when%20markets%20rebound"><img loading="lazy" decoding="async" width="1024" height="147" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/26030246/Screenshot-2025-06-26-at-12.32.31-PM-1024x147.png" alt="" class="wp-image-962643" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/26030246/Screenshot-2025-06-26-at-12.32.31-PM-1024x147.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/26030246/Screenshot-2025-06-26-at-12.32.31-PM-300x43.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/26030246/Screenshot-2025-06-26-at-12.32.31-PM-768x110.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/26030246/Screenshot-2025-06-26-at-12.32.31-PM.png 1536w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>
Merck scores well on Growth in Benzinga&#8217;s Edge Stock Rankings, with a favorable price trend in the short term. How does it compare with Pfizer and Moderna? Click <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-2#:~:text=Turn%20Market%20Chaos,when%20markets%20rebound">here</a> to find out.
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Politics

RFK Jr. Overhauls CDC Vaccine Panel, Sparking Expert Backlash, Boycott From Top Medical Group

Merck Says It Will Host HIV Research Pipeline Investor Event On July 17, 2025, Highlighting Advances In Treatment And Prevention

Merck &amp; Co., Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) on Monday announced positive topline results from the Phase 3 HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH) functional class (FC) II or III at intermediate or high <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">risk of disease progression</a>.
HYPERION met its primary endpoint of time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization &gt; 24 hours, atrial septostomy, lung transplantation, or PAH deterioration.
In HYPERION, Winrevair added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46048204/merck-announces-phase-3-hyperion-study-of-winrevair-sotatercept-csrk-met-primary-endpoint-in-recen" rel="noreferrer noopener">compared to placebo</a>.
Also Read: <a href="https://www.benzinga.com/25/01/42768614/uk-approves-mercks-hypertension-drug-acquired-via-11-billion-acceleron-pharma-deal" target="_blank" rel="noreferrer noopener">UK Approves Merck&#8217;s Hypertension Drug Acquired Via $11 Billion Acceleron Pharma Deal</a>
HYPERION is the third Phase 3 study of Winrevair to demonstrate significant efficacy in adults with PAH.
The first was the STELLAR study previously <a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fmercks-investigational-activin-signaling-inhibitor-sotatercept-improved-six-minute-walk-distance-by-40-8-meters-at-week-24-versus-placebo-in-adults-with-pulmonary-arterial-hypertension-on-bac%2F&amp;esheet=54280587&amp;newsitemid=20250623646523&amp;lan=en-US&amp;anchor=presented&amp;index=1&amp;md5=6cc60765e3d6cde225b93aee37881f92" rel="noreferrer noopener">presented</a> at ACC.23, followed by the ZENITH study <a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fwinrevair-sotatercept-csrk-reduced-the-risk-of-a-composite-of-all-cause-death-lung-transplantation-and-hospitalization-for-pulmonary-arterial-hypertension-pah-by-76-compared-to-placebo-i%2F&amp;esheet=54280587&amp;newsitemid=20250623646523&amp;lan=en-US&amp;anchor=presented&amp;index=2&amp;md5=416e4c2984a4485bc2a8d46a139c5585" rel="noreferrer noopener">presented</a> at ACC.25.
In contrast to HYPERION, these previous studies included a patient population in which the majority of participants were on triple therapy. The safety profile of Winrevair was generally consistent with that observed in previous studies.
As <a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fmerck-announces-decision-to-stop-phase-3-hyperion-trial-evaluating-winrevair-sotatercept-csrk-early-and-move-to-final-analysis%2F&amp;esheet=54280587&amp;newsitemid=20250623646523&amp;lan=en-US&amp;anchor=announced&amp;index=3&amp;md5=4445fa17ab52f0b3036f80bce258ea20" rel="noreferrer noopener">announced</a> in January, HYPERION was stopped early and moved to final analysis based on the positive results from the interim analysis of the Phase 3 ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date.
All patients were offered the opportunity to receive Winrevair through the SOTERIA open-label extension study.
Winrevair is currently approved in more than 45 countries based on the results <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37958211/mercks-11b-bet-pays-as-fda-approves-sotatercept-for-rare-lung-disease" rel="noreferrer noopener">from the STELLAR study</a>.
Price Action: MRK stock is trading higher by 0.44% to $79.41 at last check Monday.
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Merck's Hypertension Drug Cuts Clinical Worsening Risk In Over 70% Of Patients On Double Background Therapy

<ul>
<li>WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70% of whom were on double background therapy</li>
<li>HYPERION, third Phase 3 study to demonstrate significant efficacy in adults with PAH, was previously stopped early based on review of available data from clinical program</li>
</ul>

Merck Announces Topline Results From Phase 3 HYPERION Study Of Winrevair (Sotatercept) In Recently Diagnosed Adults With Pulmonary Arterial Hypertension, The Study Met Its Primary Endpoint Of Time To Clinical Worsening Vs. Placebo

A surge in demand for weight-loss and diabetes medications, paired with fears of incoming tariffs, has propelled Ireland to the center of a pharmaceutical trade boom with the U.S., dramatically widening the <a target="_blank" href="https://www.benzinga.com/topic/weight-loss" rel="noreferrer noopener">bilateral trade imbalance</a>.
This year alone, $36 billion worth of hormone ingredients—essential for popular drugs like GLP-1 treatments and insulin analogs—have been flown from Ireland to the U.S., more than doubling last year&#8217;s total.
The Wall Street Journal <a target="_blank" href="https://www.wsj.com/health/pharma/how-weight-loss-drugs-blew-out-the-u-s-trade-deficit-2d8c668c" rel="noreferrer noopener">stated</a> that these pharmaceutical ingredients weighed 23,400 pounds, were highly concentrated, and shipped in temperature-controlled containers.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45998123/scholar-rocks-atrophy-drug-when-combined-with-eli-lillys-zepbound-shows-around-55-better-muscle-preservation-in-weight-loss-study" rel="noreferrer noopener">Scholar Rock&#8217;s Atrophy Drug When Combined With Eli Lilly&#8217;s Zepbound Shows Around 55% Better Muscle Preservation In Weight Loss Study</a>
Nearly all were bound for Indiana, where Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), the maker of blockbuster drugs Zepbound and Mounjaro, is based.
The company began manufacturing these products in its Kinsale, Ireland facility last year and is now preparing to seek U.S. approval for a weight-<a target="_blank" href="https://www.benzinga.com/25/04/44860903/eli-lillys-oral-glp-1-drug-orforglipron-hits-phase-3-goals-in-diabetes-trial-stock-shoots-higher" rel="noreferrer noopener">loss pill, orforglipron</a>.
This airlift of peptide and protein-based hormones, compounds that regulate appetite and metabolism, has played a key role in pushing Ireland to the second spot on U.S. goods-trade deficits, trailing only China.
In the first four months of 2025, the U.S. imported $71 billion in goods from Ireland, with hormone ingredients accounting for nearly half.
The rush stems from both commercial and geopolitical pressures. Former President Donald Trump&#8217;s shifting trade policies have triggered stockpiling by pharmaceutical companies racing to beat tariff deadlines.
A Section 232 investigation launched in April could lead to new levies on imported <a target="_blank" href="https://www.benzinga.com/government/regulations/25/04/44847222/trump-administration-opens-probe-into-foreign-drug-imports-eyes-tariffs-under-national-security-law" rel="noreferrer noopener">drugs and active ingredients</a>.
The report added that Ireland, home to just 5.4 million people, is a hub for U.S. pharmaceutical manufacturing, partly due to its favorable tax structure.
Giants like AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) and Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) produce leading treatments such as Botox and Keytruda there.
Ireland&#8217;s central bank <a target="_blank" href="https://www.benzinga.com/markets/eurozone/25/06/46034817/us-multinationals-including-pharma-firms-power-over-5-of-eurozone-economy-ecb-says" rel="noreferrer noopener">attributed</a> a nearly 10% GDP growth in Q1 to soaring pharma exports.
However, the trade imbalance has drawn scrutiny. Ireland was recently added to the U.S. Treasury Department&#8217;s currency manipulation watchlist. Dan O&#8217;Brien of Dublin&#8217;s Institute of International and European Affairs said the attention is &#8220;definitely not welcome,&#8221; especially as Ireland alone accounts for a large share of the U.S.-EU deficit.
The logistical strain is also evident. Pharma shipments from Ireland to the U.S. more than doubled in March and April, with logistics firms working overtime. Lufthansa Cargo and Kuehne + Nagel reported increased volumes, although activity began to slow in April as U.S. warehouses filled up.
As the White House pushes to onshore drug manufacturing, companies like Lilly and Merck are ramping up domestic investments, aiming to reduce reliance on foreign supply chains amid regulatory uncertainty.
Price Action: LLY stock is down 2.55% at $765.05&nbsp;at the last check Friday.
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</ul>
Photo by M7kk via Shutterstock

Media

Obesity Drugs Help With Weight Loss But Are Adding Fat Elsewhere

A heated debate over the U.S. healthcare system erupted on X, pitting billionaire entrepreneur Mark Cuban against Sen. Elizabeth Warren (D-Mass) over the root causes of soaring drug prices.
What Happened: The clash, unfolding as of Friday, has reignited discussions on Pharmacy Benefit Managers (PBMs) and Big Pharma's tax practices, with the Senate poised to address reform amid rising public scrutiny.
Enter Cuban, the Dallas Mavericks owner and founder of Cost Plus Drugs, who fired back with a pointed correction.
In a post quoting Warren, Cuban argued that PBMs—not Big Pharma—are the true culprits behind inflated drug prices.
&#8220;PBMs corrupt healthcare,&#8221; he wrote, explaining that these intermediaries control formularies and manipulate prices to maximize rebate revenue, with <a href="https://www.benzinga.com/25/05/45487788/trumps-drug-price-order-hits-pbms-hardest-cvs-cigna-unh-in-focus-as-experts-highlight-racket-and-pricing-distortion">three major PBMs</a> negotiating over 90% of rebates for commercial insurance plans. 
Warren, in her post, had blamed pharmaceutical giants like Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) and Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) for charging Americans the &#8220;highest drug prices in the world&#8221; while paying &#8220;zero dollars in federal taxes.&#8221;
Citing data from her Senate Finance Committee role, Warren highlighted how these companies, alongside AbbVie Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), Amgen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), and Merck &amp; Co Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), have exploited tax loopholes from the 2017 Tax Cuts and Jobs Act to shield billions in profits.
&#8220;Republicans want to make it worse. I&#8217;m fighting back,&#8221; she declared, sharing <a href="https://www.cnbc.com/2025/06/17/pfizer-merck-jj-others-face-scrutiny-over-tax-loophole-extension.html">a</a> CNBC headline and urging action against what she calls a &#8220;rigged tax system.&#8221; 
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">No. It&#39;s because PBMs corrupt healthcare. Big Pharma wishes they could set their own pricing. They don&#39;t. PBMs control formularies and manipulate prices, in exchange for providing pharma access to patients. It&#39;s how they maximize rebate revenue. In fact, 3 PBMs NEGOTIATE… <a href="https://t.co/GpN4mnzvOM">https://t.co/GpN4mnzvOM</a>
&mdash; Mark Cuban (@mcuban) <a href="https://twitter.com/mcuban/status/1935705831930298562?ref_src=twsrc%5Etfw">June 19, 2025</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
See Also:&nbsp;<a href="https://www.benzinga.com/etfs/sector-etfs/25/06/46013679/dan-ives-says-market-is-massively-underestimating-this-ai-play-urges-investors-to-look-beyong-mag-7">Dan Ives Says Market Is ‘Massively Underestimating' This AI Play, Urges Investors To Look Beyond Mag 7</a>
Why It Matters: Cuban has been a c<a href="https://www.benzinga.com/personal-finance/25/04/44674382/mark-cuban-says-big-insurance-companies-and-pbms-control-healthcare-costs-everyone-has-to-kiss-their-a-and-accept-the-complications">ritic of the healthcare system</a>, saying that it should be simple. According to him, it&#8217;s become overly complicated by big insurance companies and PBMs.
These groups, he says, act as middlemen, controlling not just the costs but also the accessibility of care.
He blames PBMs for lack of transparency, inflated specialty drug prices, rebate distortion, formulary restrictions, and &#8220;Sh–ing on&#8221; on independent pharmacies.
Some significant firms engaged in the PBM business listed in the U.S. include;
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Stocks</td>
<td>YTD Performance</td>
<td>One Year Performance</td>
</tr>
<tr>
<td>CVS Health Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>)</td>
<td>51.15%</td>
<td>9.57%</td>
</tr>
<tr>
<td>Cigna Group. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>)</td>
<td>14.54%</td>
<td>-6.95%</td>
</tr>
<tr>
<td>UnitedHealth Group Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>)</td>
<td>-39.11%</td>
<td>-36.60%</td>
</tr>
</tbody>
</table>
</figure>
Meanwhile, here is how some pharmaceutical sector ETFs have performed;
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Pharma ETFs</td>
<td>YTD Performance</td>
<td>One Year Performance</td>
</tr>
<tr>
<td>VanEck Pharmaceutical ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PPH#NASDAQ">PPH</a>)</td>
<td>1.69%</td>
<td>-4.48%</td>
</tr>
<tr>
<td>iShares US Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IHE#NYSE">IHE</a>)</td>
<td>-0.49%</td>
<td>-1.85%</td>
</tr>
<tr>
<td>Invesco Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PJP#NYSE">PJP</a>)</td>
<td>-3.23%</td>
<td>-1.64%</td>
</tr>
<tr>
<td>SPDR S&amp;P Pharmaceuticals ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XPH#NYSE">XPH</a>)</td>
<td>-4.06%</td>
<td>2.61%</td>
</tr>
<tr>
<td>KraneShares MSCI All China Health Care Index ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KURE#NYSE">KURE</a>)</td>
<td>20.55%</td>
<td>22.94%</td>
</tr>
<tr>
<td>First Trust Nasdaq Pharmaceuticals ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FTXH#NASDAQ">FTXH</a>)</td>
<td>-5.44%</td>
<td>-6.27%</td>
</tr>
<tr>
<td>Direxion Daily Pharmaceutical &amp; Medical (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PILL#NYSE">PILL</a>)</td>
<td>-23.49%</td>
<td>-14.63%</td>
</tr>
</tbody>
</table>
</figure>
The SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) and Invesco QQQ Trust ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>), which track the S&amp;P 500 index and Nasdaq 100 index, respectively, were mixed in premarket on Friday. The SPY was down 0.30% at $595.67, while the QQQ was 0.015% higher at $529.07, according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a> data.
Read Next:
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo courtesy: Shutterstock

Insurance

Mark Cuban Corrects Elizabeth Warren As She Slams JNJ, PFE For Higher Prices And Zero Taxes On Big Pharma: 'PBMs Corrupt Healthcare'

Editor's Note: This story has been updated to correct the name of the Citigroup analyst responsible for the downgrade of Merck.
During times of turbulence and uncertainty in the markets, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a<a href="https://www.benzinga.com/yield-investments"> high dividend payout</a>.
Benzinga readers can review the latest analyst takes on their favorite stocks by visiting <a href="https://www.benzinga.com/analyst-stock-ratings">Analyst Stock Ratings</a> page. Traders can sort through Benzinga's extensive database of analyst ratings, including <a href="https://www.benzinga.com/analyst-ratings/analyst-color/22/09/28888638/exclusive-study-finds-benzinga-analyst-ratings-data-yields-market-beating-strategie">by analyst accuracy</a>.
Below are the ratings of the most accurate analysts for three high-yielding stocks in the health care sector.
<h3 class="wp-block-heading">Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 7.17%</li>
<li>UBS analyst Trung Huynh maintained a Neutral rating and increased the price target from $24 to $25 on April 30, 2025. This analyst has an accuracy rate of 71%.</li>
<li>Guggenheim analyst Vamil Divan reiterated a Buy rating on March 18, 2025. This analyst has an accuracy rate of 74%.</li>
<li>Recent News: Arvinas, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARVN#NASDAQ">ARVN</a>) on June 6 announced in a press release the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) with its partner Pfizer.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to latest PFE <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0618">news</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0618"><img loading="lazy" decoding="async" width="910" height="843" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053555/image-280.png" alt="" class="wp-image-953567" style="width:608px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053555/image-280.png 910w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053555/image-280-300x278.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053555/image-280-768x711.png 768w" sizes="(max-width: 910px) 100vw, 910px" /></a></figure>
<h3 class="wp-block-heading">Merck &amp; Co., Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 4.14%</li>
<li>Citigroup analyst Geoff Meacham downgraded the stock from Buy to Neutral and cut the price target from $115 to $84 on May 14, 2025. This analyst has an accuracy rate of 70%.</li>
<li>Guggenheim analyst Vamil Divan reiterated a Buy rating with a price target of $115 on April 17, 2025. This analyst has an accuracy rate of 74%.</li>
<li>Recent News: The U.S. Food and Drug Administration (FDA) on Friday approved Merck's Keytruda (pembrolizumab) for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score of at least 1), 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.</li>
<li>Benzinga Pro's real-time newsfeed alerted to latest MRK <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0618">news </a></li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0618"><img loading="lazy" decoding="async" width="917" height="825" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053627/image-281.png" alt="" class="wp-image-953569" style="width:590px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053627/image-281.png 917w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053627/image-281-300x270.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053627/image-281-768x691.png 768w" sizes="(max-width: 917px) 100vw, 917px" /></a></figure>
<h3 class="wp-block-heading">DENTSPLY SIRONA Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XRAY#NASDAQ">XRAY</a>)</h3>
<ul class="wp-block-list">
<li>Dividend Yield: 4.16%</li>
<li>UBS analyst Kevin Caliendo maintained a Buy rating and cut the price target from $27 to $25 on May 9, 2025. This analyst has an accuracy rate of 71%.</li>
<li>Mizuho analyst Steven Valiquette maintained a Neutral rating and lowered the price target from $21 to $18 on March 13, 2025. This analyst has an accuracy rate of 62%.</li>
<li>Recent News: On June 5, Dentsply Sirona priced an offering of $550 million of junior subordinated notes.</li>
<li>Benzinga Pro&#8217;s real-time newsfeed alerted to latest XRAY <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0618">news </a></li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0618"><img loading="lazy" decoding="async" width="922" height="821" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053656/image-282.png" alt="" class="wp-image-953570" style="width:581px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053656/image-282.png 922w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053656/image-282-300x267.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18053656/image-282-768x684.png 768w" sizes="(max-width: 922px) 100vw, 922px" /></a></figure>
<figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"> 
<div class="wp-block-embed__wrapper">
<iframe loading="lazy" title="How to Find Dividend Stocks: Scan, Analyze, and Capture with Benzinga Pro" width="500" height="281" src="https://www.youtube.com/embed/pVF0O2lsEH4?start=1&#038;feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
</div>
</figure>
Read More: 
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<li><a href="https://www.benzinga.com/trading-ideas/short-ideas/25/06/45970767/top-3-health-care-stocks-that-are-ticking-portfolio-bombs">Top 3 Health Care Stocks That Are Ticking Portfolio Bombs</a></li>
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Photo: Shutterstock

Long Ideas

Dividends

Price Target

Pre-Market Outlook

ARVN

XRAY

Wall Street's Most Accurate Analysts Give Their Take On 3 Health Care Stocks Delivering High-Dividend Yields (CORRECTED)

CORRECTION: Citigroup analyst Geoff Meacham downgrades Merck &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) from Buy to Neutral and lowers the price target from $115 to $84.

Downgrades

CORRECTION: Citigroup Downgrades Merck & Co to Neutral, Lowers Price Target to $84

Healthcare stocks are trailing the broader market by margins not seen since 2008, as tumbling pharma giants and a stampede toward tech and AI names have left the sector <a href="https://www.benzinga.com/markets">deeply out of interest.</a>
The Healthcare Select Sector SPDR Fund (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XLV#NYSE">XLV</a>) now trades at just 0.2234 shares of the S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>), its weakest relative value in more than a decade. In 2015, that ratio was 0.35, making today&#8217;s level a 40% drop in comparative value.
In May 2025, healthcare lagged the S&amp;P 500 by 11.2%, the worst single-month relative performance since records began. Versus the red-hot tech sector, the gap is even more extreme — at levels last seen in February 2000.
Have we been here before? Yes, and history suggests this kind of extreme undervaluation often triggers powerful reversals.
<h3 class="wp-block-heading">The Last Time Healthcare Was This Unloved Was In 2008&#8230;</h3>
<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="528" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18082457/image-283-1024x528.png" alt="" class="wp-image-953798" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18082457/image-283-1024x528.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18082457/image-283-300x155.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18082457/image-283-768x396.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18082457/image-283-1536x792.png 1536w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18082457/image-283-2048x1056.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
Chart: TradingView
<h3 class="wp-block-heading">&#8230;When A Monster Rally Followed</h3>
After similar dislocations in May 2008 and October/November 2001, healthcare stocks sharply outpaced the broader market. 
From November 2001 to September 2002, the sector outperformed the S&amp;P 500 by 41%. From June 2008 to February 2009, it beat the market by a similar 40%.
<ul class="wp-block-list">
<li>Read More: <a href="https://www.benzinga.com/markets/guidance/25/06/45928561/gold-biggest-boom-in-decades-and-investors-are-still-missing-out">Gold&#8217;s Biggest Boom In Decades—And Investors Are Still Missing Out</a></li>
</ul>
When compared to tech stocks, the comeback is even more dramatic. 
Between March 2000 and September 2002, healthcare outperformed the Invesco QQQ Trust (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>) by a staggering 390% as the dot-com bubble burst. 
These episodes followed the same pattern: investors often chased growth stocks until valuations became extreme. 
Healthcare, seen as a comparatively safer sector, then spiked as capital rotated back to battered value and defensive names.
<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="528" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18085730/image-288-1024x528.png" alt="" class="wp-image-953845" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18085730/image-288-1024x528.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18085730/image-288-300x155.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18085730/image-288-768x396.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18085730/image-288-1536x792.png 1536w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/18085730/image-288-2048x1056.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
<h3 class="wp-block-heading">What's Triggering The Current Healthcare Slump?</h3>
Big pharma and healthcare insurers are dragging the whole sector lower. UnitedHealth Group Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>) is down 40% year to date, its second-worst year since 1987.
Eli Lilly and Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) fell 18% in May, its steepest monthly drop since February 2009. 
Meanwhile, Merck &amp; Co. Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) has logged nine straight months of declines — a feat unmatched since the company went public in 1970.
<h3 class="wp-block-heading">Are Healthcare Stocks A Buy Right Now?</h3>
Wall Street analysts are optimistic that the sector might soon head towards a turnaround.
Of the 60 companies in the Healthcare Select Sector SPDR Fund, 59 have average 12-month analyst price targets above current market prices. The sector's weighted average upside stands at 17%.
For key players in the sector, Eli Lilly has a median analyst target that&#8217;s 22% above its current share price. UnitedHealth Group is expected to rise by 18%, while Merck &amp; Co. is forecasted 27% higher the next 12 months.
More traditional valuation metrics also support the bullish case. The sector trades at a forward price-to-earnings ratio of 21, well below the 30 for the S&amp;P 500 — highlighting just how steep the current discount is.
Read now:
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</ul>
Photo: Shutterstock

Sector ETFs

Tech

ETFs

Nobody Wants To Touch Healthcare Stocks Now – That Might Be A Big Mistake

FDA priority review and approval based on interim results sets a positive precedent, paving the path for future Multikine approval
Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival
Pre-operative treatments from CEL-SCI and Merck have the potential to offer clinical benefit for locally advanced resectable head and neck cancer patients across the PD-L1 expression spectrum
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2F&amp;esheet=54277978&amp;newsitemid=20250618276691&amp;lan=en-US&amp;anchor=CEL-SCI+Corporation&amp;index=1&amp;md5=b70d9fa9d0281b85f045cc590edcf07d">CEL-SCI Corporation</a> (NYSE:<a href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) today applauded the U.S. Food and Drug Administration's (FDA) <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merck.com%2Fnews%2Ffda-approves-keytruda-pembrolizumab-for-pd-l1-resectable-locally-advanced-head-neck-squamous-cell-carcinoma-as-neoadjuvant-treatment-continued-as-adjuvant-treatment-combined-with-radiother%2F&amp;esheet=54277978&amp;newsitemid=20250618276691&amp;lan=en-US&amp;anchor=approval&amp;index=2&amp;md5=d0921aab7b73e58ab873719f9dc49400">approval</a> of Merck's KEYTRUDA&#xAE; (pembrolizumab), an anti-PD-1 therapy, 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-approved test. Merck's application was granted the FDA's <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merck.com%2Fnews%2Ffda-grants-priority-review-to-mercks-application-for-keytruda-pembrolizumab-plus-standard-of-care-as-perioperative-treatment-for-resectable-locally-advanced-head-and-neck-squamous-cel%2F%23%3A%7E%3Atext%3DSearch%2520for%253A-%2CFDA%2520Grants%2520Priority%2520Review%2520to%2520Merck%27s%2520Application%2520for%2520KEYTRUDA%25C2%25AE%2Cand%2520Neck%2520Squamous%2520Cell%2520Carcinoma&amp;esheet=54277978&amp;newsitemid=20250618276691&amp;lan=en-US&amp;anchor=priority+review&amp;index=3&amp;md5=79fb8c0bc25f520e40a046b587c15102">priority review</a> on February 25, 2025, and regulatory approval was granted on June 13, 2025, based on interim results from Keytruda's Phase 3 <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03765918&amp;esheet=54277978&amp;newsitemid=20250618276691&amp;lan=en-US&amp;anchor=KEYNOTE-689&amp;index=4&amp;md5=361495621cb54f94ba824b3cb70c79cc">KEYNOTE-689</a> trial.
Last week the FDA approved Keytruda as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck's Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.
In contrast to the results of the KEYNOTE-689, CEL-SCI's Phase 3 study showed that Multikine&#x2A; treated patients whose tumors expressed low (Tumor Proportion Score [TPS &lt;10]) to zero PD-L1, had their risk of death reduced by 66% (hazard ratio 0.34, 95% CI [0.18, 0.65], p=0.0012) and extended the 5-year overall survival to 73% compared to 45% in the standard of care, log rank p=0.0015. About 70% of the patients in CEL-SCI's Phase 3 study had low to zero levels of PD-L1.

CEL-SCI Highlights FDA Approval Of Merck's Keytruda As Precedent For Multikine, Citing 66% Reduction In Risk Of Death In Low/Zero PD-L1 Head And Neck Cancer Patients vs. Keytruda's 30% Recurrence Reduction In PD-L1 Positive Tumors

Daiichi Sankyo And Merck Announced The First Patient Has Been Dosed In IDeate-Prostate01 Phase 3 Trial Of Ifinatamab Deruxtecan Versus Docetaxel In Patients With Metastatic Castration-resistant Prostate Cancer With Disease Progression During Or After Treatment With An Androgen Receptor Pathway Inhibitor

The U.S. Food and Drug Administration (FDA) on Friday approved Merck &amp; Co Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Keytruda (pembrolizumab) for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score of at least 1), as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b45921974/fda-approves-keytruda-pembrolizumab-for-pd-l1-resectable-locally-advanced-head-neck-squamous-cell-" rel="noreferrer noopener">then as a single agent</a>.
The approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1).
The approval is based on data from the pivotal Phase 3 KEYNOTE-689 trial.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45845078/mercks-cholesterol-lowering-drug-hits-primary-goal-in-two-pivotal-trials" rel="noreferrer noopener">Merck&#8217;s Cholesterol Lowering Drug Hits Primary Goal In Two Pivotal Trials</a>
At the trial&#8217;s first pre-specified interim analysis, Keytruda before surgery (neoadjuvant), then continued after surgery (adjuvant) in combination with standard of care (SOC), RT with or without cisplatin, followed by Keytruda alone, reduced the risk of event-free survival (EFS) events (defined as disease recurrence, disease progression, or death) by 30% compared to adjuvant SOC.
Among the CPS ≥1 population, the median EFS was 59.7 months in the Keytruda arm versus 29.6 months in the SOC arm.
&#8220;The introduction of Keytruda as a perioperative treatment option for certain patients with resectable locally advanced head and neck squamous cell carcinoma represents a potentially significant shift in how we manage this disease,&#8221; the Keynote-689 trial&#8217;s principal investigator, Ravindra Uppaluri, said in a statement Friday.
Earlier in June, Merck reportedly approached Swiss biotech MoonLake Immunotherapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MLTX#NASDAQ">MLTX</a>) with a <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45743008/mercks-dealmaking-intensifies-with-moonlake-bid-as-keytruda-patent-cliff-nears-report" rel="noreferrer noopener">bid exceeding $3 billion</a>.
The potential deal signals renewed dealmaking activity as investor pressure has mounted on Merck to secure new assets, especially as its blockbuster <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">cancer drug Keytruda</a> faces patent expiration as early as 2028.
In May, Merck&#8217;s Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), met its primary endpoint of progression-free survival (PFS) for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45450568/merck-says-blockbuster-keytruda-based-regimen-can-help-certain-ovarian-cancer-patients-live-longer" rel="noreferrer noopener">and in all comers</a>.
The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.
The Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45450568/merck-says-blockbuster-keytruda-based-regimen-can-help-certain-ovarian-cancer-patients-live-longer" rel="noreferrer noopener">with or without bevacizumab</a>.
Price Action: MRK stock is trading higher by 0.40% to $82.15 at last check Friday.
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Photo by tada images via Shutterstock

MLTX

Merck's Keytruda Secures FDA Nod For Head And Neck Cancer As First Immunotherapy For Use Around Surgery

Approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1)
 &nbsp;

Merck & Company Says FDA Has Approved KEYTRUDA (pembrolizumab) For PD-L1+ Resectable Locally Advanced Head & Neck Squamous Cell Carcinoma As Neoadjuvant Treatment, Continued As Adjuvant Treatment Combined With Radiotherapy With Or Without Cisplatin Then As A Single Agent

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FDA Approves KEYTRUDA® (pembrolizumab) for PD-L1+ Resectable Locally Advanced Head & Neck Squamous Cell Carcinoma as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy With or Without Cisplatin Then as a Single Agent

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