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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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Sanofi adquiere 29,6 millones de acciones a L&#39;Oréal en una transacción de 3000M€. Descubre el impacto en la empresa y sus accionistas.

Sanofi recompra 2,3% de sus acciones a L&#39;Oréal por 3000M€

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El brote de H5N9, la separación de la OMS y las audiencias de Kennedy generan incertidumbre en salud pública y mercados.

Acciones de Moderna (MRNA) y Pfizer (PFE) reaccionan al brote de H5N9 y la separación de los CDC de la OMS

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Descubre los prometedores resultados del estudio de fase 3 IRAKLIA de Sanofi sobre Sarclisa SC en mieloma múltiple.

Sanofi publica resultados prometedores del estudio de fase 3 IRAKLIA con Sarclisa

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Earendil Labs And Sanofi Entered Into A License Agreement For Two Bispecific Antibodies In The Field Of Autoimmune And Inflammatory Bowel Diseases, HXN-1002 and HXN-1003, For An Upfront Payment Of $125M And $1.72B In Milestone Payments

<a target="_blank" href="https://www.benzinga.com/quote/SNY" rel="noreferrer noopener">Sanofi SA</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) on Tuesday shared progress from its mid- to <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">late-stage respiratory pipeline</a>.
The French drug maker <a href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-15-05-00-00-3061368" target="_blank" rel="noreferrer noopener">reported</a> preliminary results from the TIDE-Asthma phase 2 study of amlitelimab and its efficacy in heterogeneous inflammatory asthma. Here&#8217;s what we know: 
<ul>
<li>The primary endpoint of the annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium and low doses.</li>
<li>Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60.</li>
<li>A nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control was evident.</li>
<li>In a patient subgroup, amlitelimab showed nominally significant and clinically meaningful improvements in exacerbations (with a reduction of more than 70%), lung function, and asthma control at week 60.</li>
<li>The phase 3 program is currently being planned.</li>
<li>In the TIDE-Asthma study, patients were treated every four weeks for the first 24 weeks and every 12 weeks for the remaining 36 weeks. Amlitelimab&#8217;s durable efficacy through 60 weeks of treatment supports a quarterly maintenance dosing schedule.</li>
<li>The safety profile was consistent with previous studies across indications, with no new safety signals identified throughout the 60-week treatment period.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44724763/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline" rel="noreferrer noopener">Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline</a>
Separately, Sanofi said lunsekimig is being explored in a broad population of asthma patients, regardless of their inflammation and severity status.
<ul>
<li>The readout of the AIRCULES phase 2 study in moderate to severe asthma is anticipated in 2026 </li>
<li>The AIRLYMPUS phase 2 study in high-risk asthma was initiated in Q4 2024.</li>
<li>The readout of the phase 2 study in patients with chronic rhinosinusitis with nasal polyps is anticipated in 2026.</li>
<li>A phase 2/3 study in chronic obstructive pulmonary disease (COPD) will begin in 2025.</li>
</ul>
In partnership with Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>), two phase 3 studies were initiated so far this year.
Itepekimab is currently being explored in COPD in two phase 3 studies, AERIFY-1 and AERIFY-2, with the readout anticipated in H2 2025, and in one phase 2 study, AERIFY-3, with the readout anticipated in H2 2025.
Finally, itepekimab is being explored in a phase 2 study in bronchiectasis, with the readout anticipated in 2026.
In May 2024, Sanofi <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-05-22-17-15-00-2886776?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" rel="noreferrer noopener">reported</a> results from the Phase 2 study of oral&nbsp;rilzabrutinib&nbsp;in adult patients with uncontrolled moderate-to-severe asthma.
Two doses of&nbsp;rilzabrutinib, 800 mg daily and 1200 mg <a target="_blank" href="https://www.benzinga.com/news/24/05/38970663/first-advanced-oral-treatment-for-asthma-sanofis-investigational-drug-shows-potential" rel="noreferrer noopener">daily, were studied</a>.
The data showed that treatment with oral&nbsp;rilzabrutinib&nbsp;at both high and low doses led to a numerical reduction in loss of asthma control (LOAC) events (the primary endpoint) and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma.&nbsp;
Price Action: SNY stock is down 1.33% at $51.15 at the last check Tuesday.
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REGN

Sanofi Asthma Drug Misses Primary Goal, Plans For Pivotal Study

Sanofi's respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD
<ul>
<li>New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma</li>
<li>Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma</li>
<li>Itepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase 3 readouts in COPD in H2 2025 and bronchiectasis in 2026</li>
</ul>

Sanofi's Amlitelimab Shows Clinically Meaningful Efficacy In Phase 2 Asthma Study, Phase 3 Program In Planning

Sanofi's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NYSE">SNY</a>) short percent of float has fallen 30.77% since its last report. The company recently reported that it has 4.00 million shares sold short, which is 0.18% of all regular shares that are available for trading. Based on its trading volume, it would take traders 1.6 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>Sanofi Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1744315224_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Sanofi has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing Sanofi's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, Sanofi's peer group average for short interest as a percentage of float is 4.11%, which means the company has less short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

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How Do Investors Really Feel About Sanofi?

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;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>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
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Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

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

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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Image: Shutterstock

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>
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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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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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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

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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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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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.

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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.
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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

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