Dernières nouvelles pour Sanofi (NASDAQ:SNY) Stock

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Sanofi develops and markets drugs with a concentration in vaccines, immunology, oncology, cardiovascular disease, diabetes, and over-the-counter treatments. However, the company's decision in late 2019 to pull back from the cardio-metabolic area will likely reduce the firm's footprint in this large therapeutic area. The company offers a diverse array of drugs with its highest revenue generator, Dupixent, representing about 30% of total sales, but profits are shared with Regeneron. Just over 40% of total revenue comes from the United States and 25% from Europe. Emerging markets represent the majority of the remainder of revenue.

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Trump Administration Health Agency Firings Include Staff Overseeing Bird Flu Response

The U.S. Food and Drug Administration on Friday approved Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">factor VIII or IX inhibitors</a>.
The <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-28-20-07-38-3051637" rel="noreferrer noopener">approval</a> is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates (ABR).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44418639/sanofi-strengthens-its-immune-system-focused-pipeline-with-around-2-billion-dren-bio-deal" rel="noreferrer noopener">Sanofi Strengthens Its Immune System-Focused Pipeline With Around $2 Billion Dren Bio Deal</a>
By lowering AT, a protein that inhibits blood clotting, Qfitlia helps increase thrombin generation to restore hemostasis in hemophilia patients.
In the ATLAS clinical development program, Qfitlia demonstrated low bleed rates across subgroups with as few as six injections a year. Key results include:
<ul>
<li>Significant bleed reduction by 71% in ABR for patients without inhibitors treated with Qfitlia prophylaxis compared to clotting factor concentrate on-demand and by 73% in ABR compared to bypassing agent on-demand for patients with inhibitors (estimated mean: ABR 5.1 vs. 19.1, respectively).</li>
<li>Median observed ABR during the open-label extension study was 3.8 in patients without inhibitors and 1.9 in patients with inhibitors.</li>
<li>The median annualized spontaneous bleeding rate observed during the open-label extension study was 1.9 in patients without inhibitors and 1.9 in patients with inhibitors.</li>
<li>Nearly half of the patients in the open-label extension study experienced one or fewer bleeds (31% zero bleeds and 47% 0-1 bleeds).</li>
</ul>
With the Qfitlia approval, the FDA cleared the Siemens Healthineers' INNOVANCE&nbsp;Antithrombin assay as a companion diagnostic for Qfitlia to measure AT levels.
Qfitlia is a small interference RNA therapeutic that utilizes Alnylam Pharmaceutical Inc.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALNY#NASDAQ">ALNY</a>) ESC-GalNAc conjugate technology.
Through the Qfitlia Testing Program with Labcorp, the FDA-cleared companion diagnostic will be available to patients prescribed Qfitlia to measure AT levels at no cost.
A regulatory submission for Qfitlia for hemophilia A or B in adults and adolescents with or without inhibitors is under review in Brazil. A regulatory decision is expected in China in the second half of 2025.
Price Action: SNY stock is down 1.74% at $54.85 during the premarket session at the last check Monday.
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ALNY

FDA Approves Sanofi's Hemophilia Drug

Sanofi Says With Qfitlia Approval, FDA Also Cleared Siemens Healthineers' Innovance Antithrombin Assay As Companion Diagnostic For Qfitlia

Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils
Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 inflammation

REGN

Regeneron And Sanofi's Dupixent Receives Japan's First Biologic Approval For Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chlamydia vaccine candidate granted fast track designation by the US FDA
<ul>
<li>Chlamydia infection can contribute to pelvic inflammatory diseases in women, which can lead to pregnancy complications or infertility</li>
<li>A phase 1/2 clinical study evaluating the immunogenicity and safety of the vaccine candidate is due to start in coming days</li>
</ul>

Sanofi's Chlamydia Vaccine Candidate Receives FDA Fast Track Designation

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
<ul>
<li>If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity</li>
<li>Tolebrutinib has the potential to be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in MS</li>
<li>Tolebrutinib was granted <a href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-12-13-06-00-00-2996609">breakthrough therapy</a> designation by the FDA based on positive results from the HERCULES phase 3 study in adults with non-relapsing secondary progressive MS</li>
</ul>

Sanofi's Tolebrutinib Granted FDA Priority Review For Non-Relapsing Secondary Progressive MS, Targeting Smoldering Neuroinflammation

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Goldman Sachs analyst James Quigley initiated coverage on Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) with a Neutral rating and announced a price target of $65. Sanofi shares closed at $57.79 on Thursday. <a href="https://www.benzinga.com/quote/SNY/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Raymond James analyst Daniel Tamayo initiated coverage on ACNB Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACNB#NASDAQ">ACNB</a>) with an Outperform rating and announced a price target of $47. ACNB shares closed at $41.25 on Thursday. <a href="https://www.benzinga.com/quote/ACNB/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>B. Riley Securities analyst Nick Giles initiated coverage on United States Antimony Corporation (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/UAMY#AMEX">UAMY</a>) with a Buy rating and announced a price target of $3. United States Antimony shares closed at $1.79 on Thursday. <a href="https://www.benzinga.com/quote/UAMY/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Maxim Group analyst Jason McCarthy initiated coverage on Anixa Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIX#NASDAQ">ANIX</a>) with a Buy rating and announced a price target of $1. Anixa Biosciences shares closed at $3.15 on Thursday. <a href="https://www.benzinga.com/quote/ANIX/analyst-ratings">See how other analysts view this stock</a>.</li>
</ul>
Considering buying ACNB stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="587" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/21091039/image-197-1024x587.png" alt="" class="wp-image-835923" style="width:467px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/21091039/image-197-1024x587.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/21091039/image-197-300x172.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/21091039/image-197-768x440.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/21091039/image-197.png 1085w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
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This ACNB Analyst Begins Coverage On A Bullish Note; Here Are Top 4 Initiations For Friday

Goldman Sachs analyst James Quigley initiates coverage on Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) with a Neutral rating and announces Price Target of $65.

Price Target

Goldman Sachs Initiates Coverage On Sanofi with Neutral Rating, Announces Price Target of $65

Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) on Thursday agreed to acquire Dren Bio Inc.&#8217;s DR-0201, a targeted bispecific <a href="https://www.benzinga.com/general/biotech" target="_blank" rel="noreferrer noopener">myeloid cell engager (MCE)</a>.
DR-0201 is a CD20-directed bispecific antibody that targets and engages specific tissue-resident and trafficking myeloid cells to induce B-cell depletion via targeted phagocytosis.
Recent early clinical study data in autoimmune diseases suggest that deep B-cell depletion might potentially reset the adaptive immune system, leading to sustained treatment-free remission in patients with refractory B-cell-mediated autoimmune diseases such as lupus.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/02/43777187/fda-approves-sanofis-merilog-as-first-rapid-acting-insulin-biosimilar-product-for-diabetes" rel="noreferrer noopener">FDA Approves Sanofi&#8217;s Merilog As First Rapid-Acting Insulin Biosimilar Product For Diabetes</a>
DR-0201 is being evaluated in two ongoing phase 1 studies.
Sanofi will <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-20-06-00-00-3045945" rel="noreferrer noopener">acquire</a> DR-0201 for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievement of certain development and launch milestones.
After the acquisition of Dren-0201, Dren Bio will continue to operate independently to advance its pipeline of antibody therapeutics that selectively deplete pathogenic cells and other disease-causing agents.
The companies expect the transaction to close during Q2 2025.
Sanofi expects to finance the transaction using available cash resources. The French pharma giant <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-01-30-06-30-00-3017713" rel="noreferrer noopener">ended</a> the fiscal year 2024 with cash and cash equivalent of 7.4 billion euros.
In October, Italian pharma company Recordati S.p.A agreed to acquire the global rights to Enjaymo, or sutimlimab, from Sanofi for $825 million as an upfront payment and additional commercial milestone <a href="https://www.benzinga.com/general/biotech/24/10/41186615/sanofi-sells-global-rights-to-rare-autoimmume-drug-enjaymo-for-825m-upfront-to-italian-firm-recor" target="_blank" rel="noreferrer noopener">payments of up to $250 million</a>.
Enjaymo, a humanized monoclonal antibody, is the only approved targeted product for cold agglutinin disease, a rare autoimmune disorder characterized by the premature destruction of red blood cells.
Price Action: SNY stock is down 1.1% at $57.95 at the last check Thursday.
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Sanofi Strengthens Its Immune System-Focused Pipeline With Around $2 Billion Dren Bio Deal

Sanofi to acquire Dren Bio's bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline
<ul>
<li>Dren Bio deep B-cell depleter program has the potential to reset the immune system</li>
<li>Acquisition underpins path for Sanofi becoming leading immunology company</li>
<li>Sanofi to pay $600 million up front</li>
</ul>

Sanofi To Acquire Dren Bio's DR-0201 For $600M Upfront, With Up To $1.3B In Milestone Payments

The U.S. Food and Drug Administration granted on Tuesday Fast Track designation to Johnson &amp; Johnson&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) investigational nipocalimab for moderate-to-severe <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">Sjögren&#8217;s disease (SjD)</a>.
Last year, FDA granted Breakthrough Therapy designation (BTD) for <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/n44374366/nipocalimab-the-first-and-only-investigational-treatment-to-be-granted-u-s-fda-breakthrough-therap" rel="noreferrer noopener">the investigational therapy</a>.
The Phase 2 DAHLIAS study, <a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4384625-1&amp;h=1495278526&amp;u=https%3A%2F%2Fwww.jnj.com%2Fmedia-center%2Fpress-releases%2Fnipocalimab-demonstrates-significant-clinical-improvement-in-disease-activity-and-igg-reduction-in-phase-2-sjogrens-disease-study&amp;a=results+of+which+were+presented+last+year" rel="noreferrer noopener">presented last year</a>, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD.&nbsp;
<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4384625-1&amp;h=1819366589&amp;u=https%3A%2F%2Fwww.jnj.com%2Fmedia-center%2Fpress-releases%2Flate-breaking-results-show-nipocalimab-significantly-improves-sjogrens-disease-activity-in-a-phase-2-study&amp;a=The+study" rel="noreferrer noopener">The study</a> achieved the primary endpoint in the 15 mg/kg Q2W nipocalimab group, showing a greater than 70% relative average improvement in systemic disease activity at Week 24 compared to placebo and IgG reductions of more than 77%.
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Trends of improvement were similarly observed across multiple secondary endpoints. Safety and tolerability were consistent with other nipocalimab clinical studies.
Sjögren&#8217;s disease, also known as Sjögren&#8217;s syndrome, is&nbsp;a chronic autoimmune disorder that primarily affects the body&#8217;s exocrine glands (or moisture-producing glands), particularly those responsible for producing tears and saliva, leading to dry eyes and mouth.
Earlier this month, Johnson &amp; Johnson decided to discontinue the Phase 3 VENTURA development program evaluating aticaprant, a kappa opioid receptor (KOR) antagonist, as an adjunctive treatment for major depressive disorder (aMDD). The move follows insufficient efficacy in the target patient population. The data confirmed aticaprant is safe and well-tolerated, and no new safety <a href="https://www.benzinga.com/25/03/44190052/johnson-johnson-stops-late-stage-depression-study-over-insufficient-efficacy" target="_blank" rel="noreferrer noopener">signals were identified</a>.
In February, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and Johnson &amp; Johnson discontinued the E.mbrace phase 3 study evaluating a vaccine candidate for extraintestinal pathogenic E. coli. The companies determined that the vaccine candidate was not sufficiently effective at preventing invasive E. coli disease (IED) <a href="https://www.benzinga.com/general/biotech/25/02/43692253/sanofi-johnson-johnson-partnered-vaccine-against-bacterial-sepsis-flunks-late-stage-study" target="_blank" rel="noreferrer noopener">compared to placebo</a>.
JNJ Price Action: Johnson &amp; Johnson stock is up 0.71% at $164 at publication Tuesday.
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FDA Grants Fast Track Review To Johnson & Johnson's Nipocalimab For Autoimmune Disorder That Affects Tears, Saliva

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'U.S. Measles Cases In 2025 Have Already Surpassed The Total For The Entire Year Of 2024' - Bloomberg

Sanofi NV (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) has been flexing its biotech muscles, and investors are taking notice. The stock is firmly in bullish territory, recently forming <a href="https://www.benzinga.com/topic/golden-cross">a Golden Cross</a>, a classic technical signal that often precedes further gains.
With momentum traders piling in and Sanofi's latest Dupixent breakthrough adding serious fuel to the rally, the stock is in the spotlight.
<h2 class="wp-block-heading">Sanofi Stock Chart Screams Bullish</h2>
<figure class="wp-block-image size-full"><a href="https://www.benzinga.com/pro/?utm_source=BZprocontent&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="618" height="487" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/12085643/Screenshot-2025-03-12-at-4.37.48-PM.png" alt="" class="wp-image-820812" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/12085643/Screenshot-2025-03-12-at-4.37.48-PM.png 618w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/03/12085643/Screenshot-2025-03-12-at-4.37.48-PM-300x236.png 300w" sizes="(max-width: 618px) 100vw, 618px" /></a></figure>
<a href="https://www.benzinga.com/pro/?utm_source=BZprocontent&amp;t=be2bearmibe3na1">Chart created using Benzinga Pro</a>
Sanofi stock is up 21.89% year-to-date. Its eight-day, 20-day, 50-day and even 200-day moving averages all point higher. 
The stock also completed a Golden Cross, where the 50-day moving average crosses above the 200-day moving average, a signal that typically indicates a long-term uptrend.
The MACD (moving average convergence/divergence) indicator sits at 1.77, another bullish signal, while an RSI (relative strength index) of 69.91 puts it just on the edge of overbought territory &#8211; suggesting the rally might still have room to run.
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<h2 class="wp-block-heading">Dupixent's Big Moment</h2>
The real game-changer? Sanofi's blockbuster drug <a href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-08-18-00-00-3039375">Dupixent just posted</a> strong Phase 2/3 trial results for treating bullous pemphigoid (BP).
The drug improves disease remission and reduces severity. It also cut the need for corticosteroids—potentially setting the stage for a first-of-its-kind treatment.
With regulatory submissions under review in the US and EU, the FDA has granted priority review, with a decision expected by June 2025. 
If approved, Dupixent could tap into yet another lucrative market, further cementing its blockbuster status.
With a Golden Cross reinforcing its bullish momentum and a major FDA decision looming, investors are watching closely—because this rally might just be getting started.
Read Next: 
<ul>
<li><a href="https://www.benzinga.com//node/44252770">Merck Injects $1 Billion To Expand Vaccine Production In US</a></li>
</ul>
Image: Shutterstock

Long Ideas

Technicals

Sanofi Stock Forms Golden Cross As Dupixent Eyes FDA Green Light: Can The Bullish Run Continue?

On Tuesday, Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) opened a new $1 billion, 225,000-square-foot facility for vaccine manufacturing at its Durham, <a target="_blank" href="https://www.benzinga.com/news/large-cap" rel="noreferrer noopener">North Carolina, site</a>.
This expansion is a crucial component of the more than $12 billion Merck has invested in the U.S. since 2018. It&#8217;s focused on expanding domestic manufacturing and research and development capabilities. The company also aims to create new jobs in the U.S., with another $8-billion capital investment <a href="https://www.benzinga.com/pressreleases/25/03/b44242543/merck-unveils-new-facility-to-increase-vaccine-production-capacity" target="_blank" rel="noreferrer noopener">by 2028</a>.
Also Read: <a href="https://www.benzinga.com/25/03/44101319/pfizer-mulls-us-manufacturing-shift-amid-looming-tariff-threats-will-the-trump-administration-co-invest-asks-analyst" target="_blank" rel="noreferrer noopener">Pfizer CEO Says Company May Shift Overseas Manufacturing To US Amid Looming Tariff Threats</a>
During the fourth quarter, Merck reported a decline of 17% in sales of Gardasil to $1.55 billion. Gardasil is a vaccine that prevents cancer from HPV, the most common sexually transmitted infection in the U.S. 
The decline is primarily due to lower demand in China, partially offset by higher demand in most international regions, <a href="https://www.benzinga.com/25/02/43461426/mercks-gardasil-vaccine-slowdown-in-china-bites-again-stock-falls-on-lower-than-expected-2025-outlook" target="_blank" rel="noreferrer noopener">particularly in Japan</a>.
Merck expects fiscal year 2025 sales of $64.1 billion-$65.6 billion versus a consensus of $67.31 billion,&nbsp;including a negative impact of foreign exchange of approximately 2% at mid-January 2025 exchange rates.
The sales range reflects a decision to temporarily pause Gardasil/Gardasil 9 shipments into China beginning February 2025 through at least mid-year.
In February, at a press conference in&nbsp;Washington, D.C.,&nbsp;Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) announced its plans to bolster its domestic medicine production across therapeutic areas by building four new pharmaceutical&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43982604/eli-lilly-doubles-capital-spending-on-us-drug-manufacturing-with-50-billion-target" rel="noreferrer noopener">manufacturing sites in&nbsp;the U.S</a>.
The company is currently negotiating with several states. The company's previous domestic capital expansion commitments from 2020 to&nbsp;<a target="_blank" href="https://www.benzinga.com/24/12/42370795/investments-in-eli-lillys-production-capabilities-reaches-23-billion-with-additional-3-billion-expansion-at-us-facility" rel="noreferrer noopener">2024 totaled&nbsp;$23 billion</a>.
In January, the U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>). 
After an inspection conducted last year, the agency flagged major concerns about Genzyme's processes <a href="https://www.benzinga.com/general/biotech/25/01/43142442/sanofi-genzyme-facility-fda-quality-lapses">for producing active pharmaceutical ingredients</a>.
Price Action: Merck stock is down 1.53% at $93.78 at the last check Tuesday.
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Image: Courtesy of Merck

Merck Injects $1 Billion To Expand Vaccine Production In US

As of March 11, 2025, three stocks in the health care sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions.
The RSI is a momentum indicator, which compares a stock&#8217;s strength on days when prices go up to its strength on days when prices go down. When compared to a stock&#8217;s price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the <a href="https://www.benzinga.com/topic/rsi">RSI is above 70</a>, according to <a href="https://pro.benzinga.com/">Benzinga Pro</a>. 
Here's the latest list of major overbought players in this sector.
<h3 class="wp-block-heading">2Seventy Bio Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSVT#NASDAQ">TSVT</a>)</h3>
<ul>
<li>On March 10, 2seventy bio agreed to be acquired by Bristol Myers Squibb for $5.00 per share in 88% premium transaction valued at $286 million. &#8220;A year ago, 2seventy decided to exclusively focus on unlocking the value of Abecma, with the goal of delivering more time for people living with multiple myeloma and maximizing value for all stakeholders,&#8221; said Chip Baird, chief executive officer, 2seventy bio. &#8220;The strategic rationale for this acquisition is clear and today&#8217;s announcement represents the culmination of the journey for 2seventy bio." The company's stock gained around 20% over the past month and has a <a href="https://www.benzinga.com/quote/TSVT">52-week high of $5.99</a>.</li>
<li>RSI Value: 82.5&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</li>
<li>TSVT Price Action: Shares of 2Seventy Bio gained 5.3% to close at $2.80 on Monday.</li>
</ul>
<h3 class="wp-block-heading">Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)</h3>
<ul>
<li>On Feb. 14, the FDA approved Sanofi's Merilog as a biosimilar to Novo Nordisk A/S‘ (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) Novolog (insulin aspart) for improving glycemic control in adults and pediatric patients with diabetes mellitus.. The company's stock gained around 10% over the past month and <a href="https://www.benzinga.com/quote/SNY">has a 52-week high</a> of $60.12.</li>
<li>RSI Value: 77.4</li>
<li>SNY Price Action: Shares of Sanofi gained 0.2% to close at $59.35 on Monday.</li>
</ul>
<h3 class="wp-block-heading">Vertex Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRTX#NASDAQ">VRTX</a>)</h3>
<ul>
<li>On Feb. 10, Vertex Pharmaceuticals posted better-than-expected quarterly sales. &#8220;2024 marked a year of tremendous growth for Vertex and we anticipate 2025 will be another important year with the landmark JOURNAVX approval and launch for moderate-to-severe acute pain; the launch of our fifth CF medicine, ALYFTREK; the continuing global launch of CASGEVY; and multiple ongoing pivotal trials. We are excited to drive diversification of the revenue base, disease areas of focus, R&amp;D pipeline, and geographies to continue to deliver long-term value to both patients and shareholders,&#8221; said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. The company's stock gained around 10% over the past month and has a <a href="https://www.benzinga.com/quote/VRTX">52-week high </a>of $519.88.</li>
<li>RSI Value: 74</li>
<li>VRTX Price Action: Shares of Vertex Pharmaceuticals gained 2.4% to close at $500.01 on Monday. </li>
</ul>
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</ul>

Short Ideas

TSVT

VRTX

Top 3 Health Care Stocks That May Keep You Up At Night In Q1

On Saturday, Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) and Kyowa Kirin Co., Ltd. <a href="https://www.benzinga.com/general/biotech">announced new results</a> from the ongoing ROCKET Phase 3 trial program rocatinlimab in moderate to severe atopic dermatitis (AD).
The IGNITE study evaluated two dose strengths of rocatinlimab and met its co-primary endpoints and all key secondary<a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/n44208802/amgen-and-kyowa-kirin-provide-top-line-results-from-rocatinlimab-phase-3-ignite-study-in-adults-wi" rel="noreferrer noopener"> endpoints versus placebo</a>.
<ul>
<li>At week 24, 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo, and 36.3% vs. 23.4% in the lower dose group.</li>
<li>In the higher dose group, 23.6% of patients achieved a validated Investigator&#8217;s Global Assessment for Atopic Dermatitis score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1) at week 24, representing a 14.9% difference vs. placebo.</li>
<li>In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44159237/amgen-challenges-novo-nordisk-and-eli-lilly-as-its-monthly-weight-loss-drug-maritide-enters-two-late-stage-trials" rel="noreferrer noopener">Amgen Challenges Novo Nordisk&#8217;s Ozempic And Eli Lilly&#8217;s Zepbound As Its Monthly Weight Loss Drug MariTide Enters Two Late-Stage Trials</a>
In addition, IGNITE met the endpoint of the revised Investigator&#8217;s Global (rIGA) Assessment score of 0/1 with a ≥2-point reduction from baseline.
<ul>
<li>At week 24, 22.7% of patients in the higher dose group achieved this endpoint, a 14.4% difference vs. placebo.</li>
<li>In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo.</li>
</ul>
The ROCKET program is also informed by the results of the SHUTTLE and VOYAGER studies.
<ul>
<li>The SHUTTLE study evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) in 746 adults using the same co-primary endpoints as IGNITE. The study met its co-primary and all key secondary endpoints.
<ul>
<li>For EASI-75, 52.3% of patients in SHUTTLE&#8217;s higher dose group achieved the endpoint, a 28.7% difference vs. placebo, while 54.1% of patients in the lower dose group achieved the endpoint, a 30.4% difference vs. placebo.</li>
<li>For vIGA-AD 0/1, 26.1% of SHUTTLE patients in the higher dose group achieved the endpoint, a 13.8% difference vs. placebo. In the lower dose group: 25.8% vs. 13.5%.</li>
<li>For rIGA 0/1, 23.3% of SHUTTLE patients in the higher dose group achieved the endpoint, an 11.5% difference vs. placebo and 22.7% vs. 10.9% in the lower dose group.</li>
</ul>
</li>
</ul>
The VOYAGER study demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations.
William Blair writes rocatinlimab results validate the OX40 mechanism, likely supporting a moderate commercial opportunity for patients after Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and Regeneron Pharmaceutical Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Dupixent and Eli Lilly &amp; Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) Ebglyss.
Price Action: AMGN stock is up 2.4% at $332.90 at last check Monday.
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Photo: Shutterstock

Amgen And Kyowa Kirin's Rocatinlimab Reduces Eczema Severity In Phase 3 Study

On Friday, Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) released new results from Ebglyss&#8217;s (lebrikizumab-lbkz) <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">long-term study, ADjoin</a>.
New data shows Ebglyss achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/n44189249/lillys-ebglyss-lebrikizumab-lbkz-single-monthly-maintenance-injection-achieved-completely-clear-sk" rel="noreferrer noopener">at three years</a>.
Ebglyss was approved in the U.S. in&nbsp;September 2024&nbsp;as a first-line monotherapy biologic treatment option following <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40884197/eli-lilly-scores-fda-approval-for-eczema-treatment-ebglyss" rel="noreferrer noopener">topical prescription therapies</a>.
Of the patients who responded to treatment at Week 16 and received once-monthly maintenance dosing, 50% achieved complete skin clearance (EASI 100 or IGA 0) at three years.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44175948/alzheimers-drugs-from-eli-lilly-and-biogen-still-deemed-too-costly-for-nhs-funding" rel="noreferrer noopener">Alzheimer&#8217;s Drugs From Eli Lilly And Biogen Still Deemed Too Costly For NHS Funding</a>
Additionally, 87% achieved or maintained almost-clear skin (EASI 90) at three years.
Over 83% of Week 16 responders taking EBGLYSS did not require concomitant therapies such as topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) for the duration of the ADjoin study.
Additional study assessments conducted in patients with skin of color (<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4376941-1&amp;h=4271923845&amp;u=https%3A%2F%2Flilly.mediaroom.com%2F2024-03-10-More-than-two-thirds-of-people-with-atopic-dermatitis-and-skin-of-color-experienced-skin-improvement-in-a-first-of-its-kind-lebrikizumab-study&amp;a=ADmirable" rel="noreferrer noopener">ADmirable</a>) and patients who were previously treated with Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) / Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent (dupilumab) (<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4376941-1&amp;h=695585820&amp;u=https%3A%2F%2Flilly.mediaroom.com%2F2024-10-25-Lillys-EBGLYSS-TM-lebrikizumab-lbkz-demonstrated-meaningful-improvement-in-skin-clearance-and-itch-relief-in-the-majority-of-patients-with-moderate-to-severe-atopic-dermatitis-who-discontinued-dupilumab&amp;a=ADapt" rel="noreferrer noopener">ADapt</a>) showed improvements in itch, skin pain (discomfort and soreness), and itch interference with sleep.
<ul>
<li>In ADmirable, nearly 60% of patients achieved significant improvement in itch and skin pain at Week 16 (58% and 59%, respectively). Over 30% of patients saw a reduction in sleep loss due to itch at Week 16.</li>
<li>In ADapt, 75% achieved significant improvement in skin pain, and 62% achieved significant improvement in itch at Week 24. 42% of patients saw a reduction in sleep loss <a href="https://www.benzinga.com/general/biotech/24/10/41553086/eli-lillys-newly-fda-approved-eczema-drug-improves-skin-and-itch-in-patients-previously-treated-w" target="_blank" rel="noreferrer noopener">due to itch at Week 24</a>.</li>
</ul>
Price Action: LLY stock is down 0.36% at $909.50 during the premarket session at the last check Friday.
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</ul>
Photo by Jonathan Weiss via Shutterstock

Eli Lilly's Single Monthly Maintenance Shot Of Eczema Drug Shows Completely Clear Skin At 3 Years In 50% Of Trial Patients

On Monday, Apogee Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APGE#NASDAQ">APGE</a>) released interim Phase 1 results from its first-in-human <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44071970/apogee-therapeutics-announces-positive-interim-phase-1-results-from-the-apg990-healthy-volunteer-t" rel="noreferrer noopener">trial of APG990</a>.
APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested.
Key data from the 40-healthy subject trial showed:
<ul>
<li>APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. The PK profile supports the potential for a single 2 mL co-formulated injection of APG279 (APG777 + APG990) administered every three and six months.</li>
<li>APG990 was well tolerated across all five cohorts, with doses up to 1,200mg. The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache.53% of participants observed at least one TEAE.</li>
<li>There were no Grade 3 TEAEs related to the study drug or severe adverse events. No adverse events led to study discontinuation. There have been no cases of pyrexia or chills.</li>
</ul>
In addition, preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents and exhibited no safety findings at any dose level, including the highest dose tested of 150 mg/kg per agent in a 3-month combination toxicology study.
The company plans to submit an Investigational New Drug application or foreign equivalent for APG279.
Following clearance, the company plans to initiate a Phase 1b clinical trial in moderate-to-severe atopic dermatitis (AD) of APG279 against Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) / Regeneron Pharmaceuticals Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Dupixent (dupilumab) in 2025, with data expected in the second half of 2026.
The company says cash, cash equivalents, and marketable securities were $731.1 million as of December 31, 2024. Based on current operating plans, Apogee expects its existing cash, cash equivalents, and marketable securities will enable the company to fund its operating expenses into the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44072186/apogee-therapeutics-provides-pipeline-progress-and-reports-full-year-2024-financial-results" rel="noreferrer noopener">first quarter of 2028</a>.
Price Action: APGE stock is up 7.14% at $33.68 at the last check Monday.
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Movers

APGE

Apogee Therapeutics' Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early Trial

On Thursday,&nbsp;Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) reported fourth-quarter 2024 sales of $88.31 million, compared to&nbsp;$291 million&nbsp;a year, beating the&nbsp;<a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $84.35 million</a>. The decrease was due to lower product sales under APA agreements.
The COVID-19 vaccine maker reported an earning loss of 51 cents per share, down from $1.44 a year ago, in line <a target="_blank" href="https://www.benzinga.com/pressreleases/25/02/n44004179/novavax-reports-fourth-quarter-and-full-year-2024-financial-results-and-operational-highlights" rel="noreferrer noopener">with the Wall Street Estimate</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42323263/wegovy-maker-novo-nordisk-to-buy-novavaxs-czech-republic-manufacturing-facility-for-200-million" rel="noreferrer noopener">Wegovy Maker Novo Nordisk To Buy Novavax&#8217;s Czech Republic Manufacturing Facility For $200 Million</a>
&#8220;In 2024, we unveiled our new corporate growth strategy, shifting our focus from commercializing our COVID-19 vaccine to maximizing the value of our cutting-edge technology platform through pipeline expansion and partnerships for our development-stage vaccine candidates and our Matrix-M adjuvant,&#8221; said&nbsp;John C. Jacobs, President and Chief Executive Officer, Novavax. &#8220;As we look to 2025 and beyond, we believe we are well positioned to potentially create significant value for all stakeholders.&#8221;
Nuvaxovid sales reached $49.8 million, down from $251.5 million a year ago. The company ended 2024 with over&nbsp;$1 billion&nbsp;in cash and accounts receivables.
Novavax has transitioned the lead commercial responsibility of Nuvaxovid to Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) for select markets beginning with the 2025-<a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38758287/some-breather-for-novavaxs-covid-19-vaccine-inks-multibillion-dollar-deal-with-sanofi-and-erases-" rel="noreferrer noopener">2026 vaccination season</a>.
Since Novavax is reliant on Sanofi&#8217;s sales forecasts for certain revenue components, these will not be included in the 2025 Revenue Framework at this time.
Novavax expects to achieve adjusted licensing, royalties, and other revenue of between&nbsp;$300 million&nbsp;and $350 million in 2025. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi sales.
<h2 class="wp-block-heading">Novavax Stock Prediction For 2025</h2>
Equity research can be a valuable source of information for learning about a company's fundamentals. Analysts create financial models based on the fundamentals and expected future earnings of a company to arrive at a price target and recommendation for the stock.
Shares of Novavax have an average 1-year price target of $19.0, representing an expected upside of 141.41%.
Because of differences in assumptions, analysts can arrive at very different price targets and recommendations. No analysts have bearish recommendations on Novavax, while 1 analysts have bullish ratings. The street high price target from HC Wainwright &amp; Co. is $19.0, while the street low from HC Wainwright &amp; Co. is $19.0.
Price Action: NVAX stock is up 10.4% at $8.08 at the last check Thursday.
Photo via Shutterstock
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