Ultime notizie per Sanofi (NASDAQ:SNY) Azioni

Sanofi

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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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Bank of America Securities <a href="https://www.benzinga.com/general/biotech">writes that SMid-cap biotech</a>, companies with small to mid-sized market capitalizations, had a rocky start to the year.
Many companies in the coverage are down 20-40% year-to-date (NBI: -2.35%).
Tariff concerns and the U.S. Food and Drug Administration (FDA) shakeup added further near-term uncertainty to an already challenging <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">already challenging outlook</a>.
Earlier this week, Peter Marks resigned from his role at the FDA&#8217;s Center for Biologics Evaluation and Research.
Marks was a top regulator at the FDA and played a key role in ensuring the quick approval of vaccines <a href="https://www.benzinga.com/25/03/44562368/moderna-novavax-shares-are-tumbling-monday-whats-going-on" target="_blank" rel="noreferrer noopener">during the COVID-19 pandemic</a>.
In March, the U.S. Department of Health and Human Services unveiled a sweeping restructuring plan on Thursday to cut costs, streamline operations and refocus priorities.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/44627279/ftc-pauses-lawsuit-against-cvs-cigna-unitedhealths-pbms-amid-commissioner-shortage" rel="noreferrer noopener">FTC Pauses Lawsuit Against CVS, Cigna, UnitedHealth&#8217;s PBMs Amid Commissioner Shortage</a>
The changes, aligned with President&nbsp;Donald Trump's&nbsp;executive order on government efficiency, will reduce the agency&#8217;s workforce, consolidate divisions, and emphasize efforts to <a target="_blank" href="https://www.benzinga.com/government/regulations/25/03/44519638/us-department-of-health-and-human-services-aligns-with-trumps-executive-order-to-cut-10k-jobs-save-18-billion" rel="noreferrer noopener">combat chronic illness</a>.
The analyst points out that public biotech companies raised only $4.7 billion, compared to $13.6 billion last year, highlighting ongoing challenges in the capital market.
&#8220;And while we see these macro headwinds as likely to continue over the course of 2025, <a href="https://www.benzinga.com/markets/25/04/44627820/trumps-reciprocal-tariffs-on-india-exempt-pharma-easing-mark-cubans-price-hike-concerns">drugs being exempt from reciprocal tariffs</a> should offer some much-needed near-term reprieve for the sector, in our view,&#8221; BofA analyst writes.
Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) is just one example of FDA. On Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax&#8217;s Covid-19 shot.
BofA expects more details on the delay in the coming weeks. The expected $125 million milestone payment from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) will likely be pushed to the second half of 2025.
Despite small and mid-cap biotech stocks being among the worst performers this year, the sector may still present a strong opportunity. Most of these companies (80%) are pre-commercial and have minimal exposure to tariffs or FDA decisions, with only 2 out of 29 under BofA coverage awaiting FDA approval.
The bigger challenges are high interest rates and limited access to capital, but these risks are already factored into valuations. While negative headlines may continue to impact sentiment and investment flows, the recent broad sell-off could be an appealing entry point.
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Image: Shutterstock

Analyst Color

Biotech

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General

Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst

The <a href="https://www.benzinga.com/topic/u-s-food-and-drug-administration">U.S. Food and Drug Administration</a> (FDA) on Thursday granted orphan drug designation to Sanofi SA&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) rilzabrutinib.
The treatment is an investigational, novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">IgG4-related disease (IgG4-RD)</a>.
The FDA grants orphan drug designation to investigational therapies that address rare medical diseases or conditions that affect fewer than 200,000 people in the US.
Rilzabrutinib is <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-03-05-00-00-3054815" rel="noreferrer noopener">currently</a> under regulatory review in the US, the EU, and China for its potential use in immune thrombocytopenia (ITP).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44440233/pharmaceutical-firms-say-uk-investment-is-unlikely-unless-payment-levy-is-adressed" rel="noreferrer noopener">Pharmaceutical Firms Say UK Investment Is &#8216;Unlikely&#8217; Unless Payment Levy Is Addressed</a>
The target action date for the FDA regulatory decision on ITP, which was granted fast-track designation, is Aug. 29.
Rilzabrutinib also received orphan drug designation for ITP in the US, EU, and Japan.
Results from a phase 2b study on wAIHA&nbsp;presented at ASH 2024 demonstrated that treatment with rilzabrutinib showed clinically meaningful outcomes on response rate and disease markers.
In IgG4-RD patients, results from a phase 2a study showed treatment with rilzabrutinib for 52 weeks led to reduction in disease flare, other disease markers, and glucocorticoid sparing.
The safety profile of rilzabrutinib in both studies was consistent with previous studies.
Last week, the FDA approved&nbsp;Sanofi&#8217;s 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&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44560065/fda-approves-sanofis-hemophilia-drug" rel="noreferrer noopener">factor VIII or IX inhibitors</a>.
The&nbsp;<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>&nbsp;is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates.
Price Action: Sanofi&#8217;s stock is up 3.54% at $55.86 during the premarket session at the last check Thursday.
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</ul>
Image: Shutterstock

Large Cap

Movers

Why Is French Pharma Giant Sanofi Stock Trading Higher On Thursday?

U.S. stocks were lower, with the Dow Jones index falling over 1,200 points on Thursday.
Shares of Lamb Weston Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LW#NYSE">LW</a>) rose sharply during Thursday's session after the company reported better-than-expected third-quarter financial results and issued FY25 sales guidance <a href="https://www.benzinga.com/quote/LW/earnings">above estimates</a>.
Lamb Weston reported quarterly earnings of $1.10 per share which beat the analyst consensus estimate of 87 cents per share. The company reported quarterly sales of $1.52 billion which beat the analyst consensus estimate of $1.49 billion.
Lamb Weston shares jumped 10% to $59.52 on Thursday.
Here are some other big stocks recording gains in today's session.
<ul>
<li>The Goodyear Tire &amp; Rubber Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GT#NASDAQ">GT</a>) shares jumped 12.5% to $10.25.</li>
<li>Northern Dynasty Minerals Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NAK#NYSE">NAK</a>) gained 12% to $1.0250.</li>
<li>Skyline Builders Group Holding Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SKBL#NASDAQ">SKBL</a>) shares rose 7.1% to $11.10.</li>
<li>National Grid plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NGG#NYSE">NGG</a>) shares rose 6.5% to $70.08.</li>
<li>SBA Communications Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBAC#NASDAQ">SBAC</a>) shares gained 6.1% to $232.69.</li>
<li>Anbio Biotechnology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NNNN#NASDAQ">NNNN</a>) rose 5.6% to $7.39.</li>
<li>The Kroger Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KR#NYSE">KR</a>) climbed 4.7% to $70.44.</li>
<li>American Tower Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AMT#NYSE">AMT</a>) shares rose 4.4% to $227.53.</li>
<li>Valneva SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VALN#NASDAQ">VALN</a>) gained 4.2% to $7.29.</li>
<li>Fresenius Medical Care AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FMS#NYSE">FMS</a>) rose 4.2% to $25.76.</li>
<li>McKesson Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MCK#NYSE">MCK</a>) gained 4% to $721.00. McKesson, on Wednesday, completed acquisition of PRISM Vision Holdings, LLC.</li>
<li>Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) rose 3% to $55.59 as the FDA granted Orphan Drug Status to the company's Rilzabrutinib for two rare autoimmune diseases with high unmet needs.</li>
</ul>
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Photo via Shutterstock

Intraday Update

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Lamb Weston Posts Better-Than-Expected Results, Joins Sanofi And Other Big Stocks Moving Higher On Thursday

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
<ul>
<li>Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease</li>
<li>Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia&nbsp;</li>
</ul>

FDA Grants Orphan Drug Status To Sanofi's Rilzabrutinib For Two Rare Autoimmune Diseases With High Unmet Needs

Nurix received a $15 million license extension fee from Sanofi under its 2019 collaboration agreement, bringing the total amount received by Nurix to date to $105 million.
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Contracts

NRIX

Nurix Licenses Drug Discovery Program To Sanofi Targeting Novel Transcription Factor For Autoimmune Diseases; Is Eligible For Additional $465M In Milestones Plus Royalties

Politics

CVAC

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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Image by HJBC via Shutterstock.

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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Photo: Shutterstock

Government

Eurozone

AMGN

BIIB

DSNKY

GILD

RHHBY

UCBJF

UCBJY

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

<a href="https://www.bloomberg.com/news/articles/2025-03-14/us-measles-cases-so-far-this-year-surpass-total-for-all-2024" title="https://www.bloomberg.com/news/articles/2025-03-14/us-measles-cases-so-far-this-year-surpass-total-for-all-2024">https://www.bloomberg.com/news/articles/2025-03-14/us-measles-cases-so-far-this-year-surpass-total-for-all-2024</a>

'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.
Read Also: <a href="https://www.benzinga.com//node/44245496">Top 3 Health Care Stocks That May Keep You Up At Night In Q1</a>
<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.
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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>.
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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

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