Ultime notizie per Sanofi (NASDAQ:SNY) Azioni

Sanofi

Sanofi American Depositary Shares (Each repstg one-half of one ordinary share)

NYSE

Sanofi develops and markets drugs with a concentration in oncology, immunology, cardiovascular disease, diabetes, over-the-counter treatments and vaccines. 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 just over 20% of total sales, but profits are shared with Regeneron. About 40% of total revenue comes from the United States and 25% from Europe. Emerging markets represent the majority of the remainder of revenue.

Sanofi SA

Synthetify

SUNNYLIFE GLOBAL INC by Sunnylife Global, Inc.

Sunnylife Global Inc

SANOFI ORD

Synergy CHC Corp

SYNERGY CHC CORP NEW by Synergy CHC Corp.

VITAL ENERGY INC (CDA) by Vital Energy, Inc.

Vital Energy Inc

SANY HEAVY EQUIP INTL HLD by Sany Heavy Equipment International Holdings Co.

Sany Heavy Equipment International Holdings Co Ltd

During times of turbulence and uncertainty in the markets, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a<a href="https://www.benzinga.com/yield-investments"> high dividend payout</a>.
Benzinga readers can review the latest analyst takes on their favorite stocks by visiting <a href="https://www.benzinga.com/analyst-stock-ratings">Analyst Stock Ratings</a> page. Traders can sort through Benzinga's extensive database of analyst ratings, including <a href="https://www.benzinga.com/analyst-ratings/analyst-color/22/09/28888638/exclusive-study-finds-benzinga-analyst-ratings-data-yields-market-beating-strategie">by analyst accuracy</a>.
Below are the ratings of the most accurate analysts for three high-yielding stocks in the health care sector.
<h3 class="wp-block-heading">Gilead Sciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>)</h3>
<ul>
<li>Dividend Yield: 3.64%</li>
<li>RBC Capital analyst Brian Abrahams maintained a Sector Perform rating and raised the price target from $74 to $75 on Oct. 4. This analyst has an accuracy rate of 61%.</li>
<li>Needham analyst Joseph Stringer reiterated a Hold rating on Aug. 15. This analyst has an accuracy rate of 76%.</li>
<li>Recent News: On Oct. 2, Dr. Reddy&#8217;s signed voluntary licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir in India and other countries.</li>
<li>Benzinga Pro's real-time newsfeed alerted to <a href="https://www.benzinga.com/pro/?utm_source=BZprocontent100724&amp;t=be2bearmibe3na1">latest GILD news</a>.</li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/?utm_source=BZprocontent100724&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="903" height="841" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071249/image-31.png" alt="" class="wp-image-583132" style="width:669px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071249/image-31.png 903w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071249/image-31-300x279.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071249/image-31-768x715.png 768w" sizes="(max-width: 903px) 100vw, 903px" /></a></figure>
<h3 class="wp-block-heading">GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)</h3>
<ul>
<li>Dividend Yield: 3.94%</li>
<li>Jefferies analyst Peter Welford maintained a Buy rating and raised the price target from $52.5 to $53 on July 2. This analyst has an accuracy rate of 68%.</li>
<li>Guggenheim analyst Seamus Fernandez upgraded the stock from Neutral to Buy on March 4. This analyst has an accuracy rate of 62%</li>
<li>Recent News: The U.S. government has granted $72 million to European pharma giants GSK Plc, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and Australian firm CSL Limited (OTC:<a class="ticker" href="https://www.benzinga.com/stock/CSLLY#OTC">CSLLY</a>) to more than double the U.S. supply of bird flu vaccines.</li>
<li>Benzinga Pro's real-time newsfeed <a href="https://www.benzinga.com/pro/?utm_source=BZprocontent100724&amp;t=be2bearmibe3na1">alerted to latest GSK news.</a></li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/?utm_source=BZprocontent100724&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="888" height="856" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071336/image-32.png" alt="" class="wp-image-583133" style="width:706px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071336/image-32.png 888w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071336/image-32-300x289.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071336/image-32-768x740.png 768w" sizes="(max-width: 888px) 100vw, 888px" /></a></figure>
<h3 class="wp-block-heading">AbbVie Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>)</h3>
<ul>
<li>Dividend Yield: 3.19%</li>
<li>Morgan Stanley analyst Terence Flynn maintained an Overweight rating and boosted the price target from $211 to $218 on Aug. 12. This analyst has an accuracy rate of 70%.</li>
<li>Wells Fargo analyst Mohit Bansal maintained an Overweight rating and raised the price target from $200 to $205 on July 26. This analyst has an accuracy rate of 75%.</li>
<li>Recent News: AbbVie will announce its third-quarter financial results on Wednesday, Oct. 30, before the opening bell.</li>
<li>Benzinga Pro&#8217;s charting tool helped identify the trend in <a href="https://www.benzinga.com/pro/?utm_source=BZprocontent100724&amp;t=be2bearmibe3na1">ABBV stock</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/?utm_source=BZprocontent100724&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="917" height="847" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071549/image-33.png" alt="" class="wp-image-583140" style="width:686px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071549/image-33.png 917w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071549/image-33-300x277.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/10/07071549/image-33-768x709.png 768w" sizes="(max-width: 917px) 100vw, 917px" /></a></figure>
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News

Dividends

Price Target

Pre-Market Outlook

Markets

Analyst Ratings

Trading Ideas

ABBV

CSLLY

GILD

Wall Street's Most Accurate Analysts Spotlight On 3 Health Care Stocks Delivering High-Dividend Yields

The U.S. government has granted $72 million to European pharma giants GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and Australian firm CSL Limited (OTC:<a class="ticker" href="https://www.benzinga.com/stock/CSLLY#OTC">CSLLY</a>) to more than double the U.S. supply of <a target="_blank" href="https://www.benzinga.com/general/24/05/39029171/after-91-million-birds-infected-with-bird-flu-in-3-years-new-findings-on-cows-raise-concerns-70-work" rel="noreferrer noopener">bird flu vaccines</a>.
According to the&nbsp;Centers for Disease Control and Prevention, bird flu was detected in 254 dairy herds across 14 states.
Including the most recent two cases in California, 16 human cases of H5 have been <a target="_blank" href="https://www.cdc.gov/media/releases/2024/s1003-birdflu-case-california.html" rel="noreferrer noopener">reported</a> in the United States during 2024, bringing the total to 17 cases since 2022.
As part of the agreement, GSK, Sanofi, and CSL will produce extra bulk vaccine components tailored to the circulating strains of avian influenza.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41166018/medicare-drug-price-negotiation-program-gets-final-guidance-for-second-cycle-1-5b-savings-expecte" rel="noreferrer noopener">Medicare Drug Price Negotiation Program Gets Final Guidance For Second Cycle, $1.5B Savings Expected</a>.
In an interview with Bloomberg, Dawn O'Connell, the assistant secretary for preparedness and response at the Department of Health and Human Services, noted that the companies plan to allocate the funds to fill vials and pre-filled syringes with stored vaccine components. The goal is to increase the nation's total supply of ready-to-administer doses to 10 million by the first quarter of 2025.
According to O'Connell, the virus responsible for the ongoing outbreak has not changed in a manner that would compromise the effectiveness of the vaccines stored in stockpiles.
Additionally, some traditional flu vaccines are produced using eggs. Sanofi will ensure a steady supply of these vaccines to the United States to prepare for potential bird flu outbreaks and other needs.
The Bloomberg <a target="_blank" href="https://www.bloomberg.com/news/articles/2024-10-04/bird-flu-vaccine-sanofi-gsk-csl-get-us-funds-to-boost-supply" rel="noreferrer noopener">report</a> added that Finland is the sole nation vaccinating its population against bird flu.
Richard Webby, a bird flu researcher at St. Jude Children's Research Hospital in Memphis, noted that similar actions may be contemplated elsewhere if genetic mutations in the H5 viruses are in circulation. However, he emphasized that "it's a bit early to initiate any type of mass vaccination at this point."
The latest award from the&nbsp;Administration for Strategic Preparedness and Response of $72 million includes $37.9 million for CSL, $23.4 million for Sanofi, and $10.5 million for GSK.
Read Next:
<ul>
<li><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">Sanofi Sells Global Rights To Rare Autoimmune Drug Enjaymo For $825M Upfront To Italian Firm Recordati</a></li>
</ul>
Image via Unsplash

Biotech

Government

Large Cap

Health Care

Financing

General

GSK, Sanofi, And CSL Secure US Government Fund To Boost Bird Flu Vaccine Production: Report

Contracts

U.S. HHS Official Says BARDA Awarding Additional $72M In New Grants For Bird Flu Vaccine Manufacturing; Bird Flu Vaccine Grants Awarded To Sanofi, GSK, And CSL; CDC Has Confirmed Two New Human Cases Of Bird Flu In California; 2 California Dairy Farm Workers That Contracted Bird Flu Had Conjunctivitis, Neither Reported Respiratory Symptoms; California Is Conducting Symptom Monitoring Of Other Exposed Workers On The Dairy Farms; 56 Dairy Farms In California Have Reported Bird Flu Infections

On Friday, Italian pharma company Recordati S.p.A agreed to acquire the global rights to Enjaymo (sutimlimab) from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) for $825 million as an upfront payment and additional commercial milestone payments of up to $250 million.
Enjaymo, a humanized monoclonal antibody, is the only approved targeted product for cold agglutinin disease (CAD), a rare autoimmune disorder characterized by the premature destruction of red blood cells&nbsp;(hemolysis).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41069388/fda-approves-regeneronsanofis-blockbuster-dupixent-for-smokers-lung-disease" rel="noreferrer noopener">FDA Approves Regeneron/Sanofi&#8217;s Blockbuster Dupixent For Smoker&#8217;s Lung Disease</a>.
The FDA approved the drug in 2022. Administered as chronic IV treatment.
Enjaymo <a target="_blank" href="https://recordati.com/wp-content/uploads/2024/10/PR_Acquisition-of-global-rights-to-Enjaymo.pdf" rel="noreferrer noopener">generated</a> approximately 100 million euros ($109.70 million) in revenue over the last 12 months as of August 2024 and is expected to generate revenue of over 150 million euros in fiscal 2025, with peak sales potential of 250 million-300 million euros, more than double current levels.
Subject to the closing date, Recordati expects minimal revenue contribution in 2024. The transaction is expected to close by the end of 2024.
The transaction is expected to be immediately accretive at the EBITDA level, with the margin above the current Rare Diseases average as of 2025.
The deal will be funded by existing cash and new committed bank debt facilities. Net debt is expected to be approximately 2.4 &#8211; 2.5x EBITDA (Pro-forma) at the end of 2024, de-leveraging to less than 2.0x EBITDA at the end of 2025, assuming no additional business development transactions.
In September, Sanofi agreed to make a&nbsp;$27 million strategic investment&nbsp;in&nbsp;Ventyx Biosciences Inc. The company also agreed to grant Sanofi an exclusive right of first negotiation with respect to certain <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40984053/sanofi-injects-27m-in-neurology-drug-developer-ventyx-biosciences" rel="noreferrer noopener">VTX3232 program rights</a>.
Price Action: SNY stock is up 0.31% at $55.71 at last check Friday.
Photo via Shutterstock
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</ul>

Equities

Asset Sales

Sanofi Sells Global Rights To Rare Autoimmune Drug Enjaymo For $825M Upfront To Italian Firm Recordati

Thermo Fisher Scientific&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) one of the largest contract drug manufacturing sites in the U.S., has repeatedly been flagged for regulatory violations.
Thermo Fisher&#8217;s Greenville facility manufactures around 40 medicines, including Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) weight-loss <a target="_blank" href="https://www.benzinga.com/general/biotech/23/10/35142181/weight-loss-drug-boom-has-another-ripple-effect-rapid-growth-expected-in-fill-finish-market" rel="noreferrer noopener">drug Wegovy (semaglutide)</a>.
Recently, Stephen&#8217;s analyst said that Thermo Fisher&#8217;s pharma services assets, especially its contract development and manufacturing organization (CDMO), are well positioned. The company is set to capitalize on growth opportunities in the injectables sector, driven by GLP-1 demand and biologics <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/10/41127566/industry-leader-thermo-fishers-contract-services-positioned-for-growth-amid-popular" rel="noreferrer noopener">drug substance production</a>.
Over the past decade, the Greenville plant has been cited for issues related to contamination prevention, including two incidents earlier this year, Reuters noted, citing FDA documents.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/earnings/24/07/39930516/thermo-fisher-q2-earnings-marginal-revenue-dip-completes-olink-acquisition-lifts-annual-profit-outl" rel="noreferrer noopener">Thermo Fisher Q2 Earnings: Marginal Revenue Dip, Completes Olink Acquisition, Lifts Annual Profit Outlook</a>.
Despite these concerns, the FDA did not take regulatory action, stating that the issues had been resolved to its satisfaction and that there was no evidence that patients had been harmed as a result.
During a recent inspection in May, the FDA identified manufacturing problems with Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Beyfortus. The respiratory syncytial virus (RSV) preventive drug for infants and toddlers scored <a target="_blank" href="https://www.benzinga.com/general/biotech/23/07/33262341/astrazeneca-sanofis-respiratory-syncytial-virus-treatment-scores-fda-approval-to-prevent-infectio" rel="noreferrer noopener">FDA approval in 2023</a>.
The Reuters report highlighted that the FDA identified 17 deficiencies during the Beyfortus audit, including insufficient visual inspections for particulate matter in injectable drugs and issues with staff handling of sterile components.
The agency noted that Thermo Fisher&#8217;s equipment sterilization procedures were inadequate, and visual inspections for injectable drug contaminants failed.
Thermo Fisher has since addressed these issues, providing the FDA with the necessary data on drug safety, including control over bubble size in injectable medications. However, experts remain concerned about the plant&#8217;s approach to quality control.
In July, Merck &amp; Co Inc&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Phase 2b/3 trial (MK-1654-004) of&nbsp;clesrovimab (MK-1654) to protect infants from respiratory syncytial virus (RSV) disease met its primary safety <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39916077/merck-competes-with-sanofiastrazeneca-as-its-rsv-treatment-drug-meets-primary-goal-in-late-stage-" rel="noreferrer noopener">and efficacy endpoints</a>.
Price Action: TMO stock is down 0.39% at $598.59 during the premarket session at last check Friday.
Read Next:
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</ul>
Photo via Shutterstock

Novo Nordisk/AstraZeneca's Manufacturing Partner Thermo Fisher Questioned Over Manufacturing Lapses

Global

NVAX

World Organization For Animal Health Says Hungary And Italy Report Farm Outbreaks Of Highly Pathogenic H5N1 Bird Flu

Monday, the U.S. Department of Health and Human Services (HHS) announced that Medicare enrollees will benefit from reduced prices on 54 drugs through Medicare Part B, effective from October 1, 2024, to December 31, 2024.
The <a target="_blank" href="https://www.hhs.gov/about/news/2024/09/30/hhs-announces-cost-savings-for-prescription-drugs-thanks-to-medicare-inflation-rebate-program.html" rel="noreferrer noopener">program</a> aims to counter drug price hikes that exceed inflation, providing financial relief for over 822,000 Medicare beneficiaries who rely on these medications to treat conditions like cancer, osteoporosis, and pneumonia.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422798/doctors-struggle-to-secure-medicare-coverage-for-heart-patients-on-novo-nordisks-wegovy" rel="noreferrer noopener">Doctors Struggle to Secure Medicare Coverage for Heart Patients on Novo Nordisk&#8217;s Wegovy</a>
HHS Secretary Xavier Becerra emphasized that the Biden administration&#8217;s prescription drug policies are making a tangible impact on seniors and people with disabilities by reducing out-of-pocket costs.
According to Chiquita Brooks-LaSure, CMS Administrator, some Medicare beneficiaries could see daily savings ranging from $1 to as much as $3,854 on drugs included in the rebate program.
For example, a cancer patient using Novartis&#8217; AGs (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Kymriah could save up to $3,000.
Brooks-LaSure also noted that the law disincentivizes drug companies from raising prices faster than inflation, which helps protect Medicare beneficiaries from sharp price increases.
The Inflation Reduction Act&#8217;s initiatives extend beyond 2024. In August, the administration reached new agreements to reduce prices for ten additional high-cost drugs.
Once these prices take effect in 2026, Medicare is projected to save an estimated $6 billion, while beneficiaries could see a reduction of $1.5 billion in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40397706/biden-administration-targets-6b-savings-through-medicare-drug-price-negotiations" rel="noreferrer noopener">out-of-pocket expenses</a>.
Starting in 2025, Medicare Part D enrollees will further benefit from a $2,000 annual cap on prescription drug costs, down from the current cap of $3,500 for those with high expenses.
According to some analysts,&nbsp;Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>)&nbsp;blockbuster diabetes drug&nbsp;Ozempic might be included, along with several other well-known medications, in the next round of negotiations, which <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534249/novo-nordisks-ozempic-might-be-among-2027-medicare-price-negotiation-targets" rel="noreferrer noopener">is set for 2027</a>.
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Photo via Shutterstock

Regulations

US HHS Reveal Cost Savings For 54 Prescription Drugs Including Novartis' Cancer Drug, Ozempic Could be Next

Sanofi Is Said To Ask For Revised Bids For Unit In Coming Days

Sanofi&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) and partner Regeneron&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) announced that the FDA has approved their blockbuster drug, Dupixent, for its sixth indication &mdash; chronic obstructive pulmonary disease (COPD) &mdash; in the United States. The approved indication is as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype. With this approval, Dupixent became the first biologic treatment approved for COPD in the United States.
Dupixent was approved for treating COPD with raised blood eosinophils in the EU in July 2024. Dupixent was also approved for the COPD indication in China last week.
Sanofi&#39;s stock has gained 16.0% so far this year compared with an increase of 20.2% for the large cap <a href="https://www.zacks.com/stocks/industry-rank/industry/large-cap-pharmaceuticals-225">pharmaceutical industry</a>.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/e4/79621.jpg?v=1565371588" style="height:310px; width:624px" />
Image Source: Zacks Investment Research
The approval for COPD, a respiratory disease that causes progressive lung function decline, was based on data from two studies. The NOTUS and BOREAS studies met their primary endpoint by showing that Dupixent significantly reduced moderate or severe acute COPD exacerbations by 30% and 34%, respectively. Dupixent also showed improvements in lung function and health-related quality of life compared to placebo.
Earlier this year, the FDA extended its decision on a supplemental biologics license application seeking approval of Dupixent for COPD from June 27 to Sept. 27.
<h3>Dupixent &ndash; Key Top-Line Driver For SNY, REGN</h3>
Dupixent is currently approved in several countries, including the United States and EU, for five other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Dupixent is being jointly marketed by Regeneron and&nbsp;Sanofi&nbsp;under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug. The approval for the COPD indication can significantly boost sales of Dupixent. Some analysts expect total sales of Dupixent for COPD to be around $6 billion.
Dupixent is a key top-line driver for both Sanofi and Regeneron on strong demand trends. In the first half of 2024, Dupixent generated global product sales of $&euro;6.1 billion, which were recorded by Sanofi, representing growth of 27.1% at a constant exchange rate. Sanofi expects Dupixent to achieve more than &euro;13 billion in sales in 2024.
For Regeneron, Dupixent generated collaboration revenues of $2.06 billion in the first half, up 18% year over year.
<h2>SNY Zacks Rank and Other Stocks to Consider</h2>
Sanofi currently has a Zacks Rank #2 (Buy).
<div class="chart_embed">
<h3>Sanofi Stock Price and Consensus</h3>
<a href="https://www.zacks.com/stock/chart/SNY/price-consensus-chart?icid=chart-SNY-price-consensus-chart"><img alt="Sanofi Price and Consensus" src="https://staticx-tuner.zacks.com/images/charts/44/1727692069.png" style="height:287px; width:624px" title="" /> </a>
<a href="https://www.zacks.com/stock/chart/SNY/price-consensus-chart?icid=chart-SNY-price-consensus-chart">Sanofi price-consensus-chart</a> | <a href="https://www.zacks.com/stock/quote/SNY?icid=chart-SNY-price-consensus-chart">Sanofi Quote</a>
</div>
Some other top-ranked drug/biotech companies are Eli Lilly (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/lly#NYSE">LLY</a>) and Pfizer (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>). While Lilly sports a Zacks Rank #1 (Strong Buy), Pfizer has a Zacks Rank #2. You can see <a href="https://www.zacks.com/stocks/buy-list/?ADID=zp_1link&amp;ICID=zpi%20_1link">the complete list of today&#39;s Zacks #1 Rank stocks here</a>.
Estimates for Lilly&#39;s 2024 earnings have risen from $13.79 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.44 to $23.97 per share over the same timeframe. Year to date, Lilly&#39;s stock has risen 50.5%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
The Zacks Consensus Estimate for Pfizer&#39;s earnings has risen from $2.38 to $2.62 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.74 per share to $2.85 per share. Pfizer&#39;s shares have risen 1.0% year to date.
Pfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.82%.
<a href="https://www.zacks.com/">Zacks Investment Research</a>

REGN

Sanofi, Regeneron's Dupixent Gets FDA Approval For COPD

Macro Economic Events

Economics

World Organization For Animal Health Says Germany Reports Outbreak Of Highly Pathogenic H5N1 Bird Flu On Farm In Eastern Part Of The Country

On Friday, the FDA approved Regeneron Pharmaceuticals, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent&nbsp;(dupilumab) as an add-on maintenance treatment of inadequately controlled chronic obstructive pulmonary disease (COPD) and an <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g41067118/dupixent-dupilumab-approved-in-the-u-s-as-the-first-ever-biologic-medicine-for-patients-with-copd" rel="noreferrer noopener">eosinophilic phenotype</a>, generally known as &#8220;smoker&#8217;s lung.&#8221;
Dupixent is the first biologic medicine approved in the U.S. to treat these patients.&nbsp;&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40814475/sanofi-regeneron-drug-dupixent-shows-successful-treatment-of-patients-with-inflammatory-skin-dise" rel="noreferrer noopener">Sanofi, Regeneron Drug Dupixent Shows Successful Treatment Of Patients With Inflammatory Skin Disease</a>.
The FDA approval is based on data from two Phase 3 trials (<a target="_blank" href="https://www.globenewswire.com/Tracker?data=7kKUkEN_j7dfFFaJgSlNFzKZoO4mFwp3ozmSi0rwdtS0dUmDMMLRg3ML03GEfgLzJP_Yg33hoRBP-3IabEFUjTEGB_rbTRFqm_JL_llzjsfHVLX2ednnpkFojo7lpUCTxdCo_2YiyMr0ctlswWAwXOheTav4f6f3NjyHRNKi9AkNKqyHtmSD_t9WycxSdyDJF-7MluPxoOJfAy9kkVjGMA==" rel="noreferrer noopener">BOREAS</a> and&nbsp;<a target="_blank" href="https://www.globenewswire.com/Tracker?data=6PGgHroz2kXLk3EuPbMe_MIJ-5vFWDjqk9axy8qZd2P7xQ3L3g2ASjHZ8xt1uzCTdZuMSDrpF3jIDhOGYYWxNY22Nyhv04bkd8VwfNHxSVov8kQjYXAerk1eaKGoDXJDxNmLd9JxB76ojM5ft65Yy_p10fVEAMfMBBDCl7C-sv2-eIX7C8dxYBsnfHK7AYcbsomWIUjlfALjFhRk2bqT3w==" rel="noreferrer noopener">NOTUS</a>) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy (nearly all on triple therapy).
<ul>
<li>Patients who received Dupixent in BOREAS (n=468) and NOTUS (n=470) experienced the following outcomes, respectively, compared to placebo (BOREAS n=471; NOTUS n=465):</li>
<li>The primary endpoint is a 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks.</li>
<li>74mL and 68mL numerically greater improvements in post-bronchodilator FEV1 from baseline at week 12 compared to placebo, sustained at 52 weeks. Statistically significant improvements of similar magnitude were observed in pre-bronchodilator FEV1 from baseline at 12 and 52 weeks, a key secondary endpoint.</li>
<li>51% response in a health-related quality of life measure in both trials compared to 43% and 47% with placebo at 52 weeks.</li>
</ul>
About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy.
In the U.S., approximately 300,000 people live with inadequately controlled COPD and an eosinophilic phenotype.
Patients with an eosinophilic phenotype contribute to a ~30% increase in exacerbations and an increased risk of COPD-related re-hospitalizations within a year.
Today, China&#8217;s National Medical Products Administration also approved Dupixent&nbsp;(dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease characterized by <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g41063987/dupixent-dupilumab-approved-in-china-as-the-first-ever-biologic-medicine-for-patients-with-chronic" rel="noreferrer noopener">raised blood eosinophils</a>.
The approval is based on BOREAS and NOTUS Phase 3 trial results.
Price Action:&nbsp;At last check Friday, REGN stock was up 2.86% at $1,069.75, and SNY stock was up 1.49% at $57.85.
Read Next:
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<li><a href="https://www.benzinga.com/news/large-cap/24/09/41067826/federal-investigations-continue-for-psychiatric-hospital-chain-operator-acadia-healthcare-even-aft" target="_blank" rel="noreferrer noopener">Federal Investigations Continue For Psychiatric Hospital Chain Operator Acadia Healthcare Even After $20M Settlement Over False Claims Allegations</a>.</li>
</ul>

Movers

FDA Approves Regeneron/Sanofi's Blockbuster Dupixent For Smoker's Lung Disease

In an investor update on Tuesday,&nbsp;Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) released data from Phase 3 trials of rocatinlimab and Uplizna (inebilizumab).
HORIZON Phase 3 trial evaluated rocatinlimab for atopic dermatitis (eczema) <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/41022603/amgens-rocatinlimab-data-beats-placebo-in-atopic-dermatitis-trial-but-analyst-says-" rel="noreferrer noopener">in 726 patients</a>.
Amgen&nbsp;<a target="_blank" href="https://investors.amgen.com/static-files/a7119a35-06de-497e-ba75-146404c54d95" rel="noreferrer noopener">reported</a> that rocatinlimab outperformed a placebo regarding the severity and extent of the disease.
Amgen stock is trading lower as the data seemed to be below expectations.
Goldman Sachs notes that although the Phase 3 efficacy data for rocatinlimab is less compelling compared to Dupixent, the analyst still sees strong commercial potential for the drug (if approved).
This is due to its favorable safety and tolerability profile, convenient dosing schedule, and the substantial total addressable market for atopic dermatitis, even with the high level of competition in the space, including Eli Lilly And Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) Ebglyss (lebrikizumab) and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)&nbsp;amlitelimab.
The analysts view the recent updates as encouraging but note that the stock still doesn&#8217;t fully reflect the potential value of either asset.
The firm models peak sales for rocatinlimab in atopic dermatitis to reach around $4 billion by 2035 (with a 60% probability of success).
While not included in the model, the analyst sees a significant opportunity for Uplizna in generalized myasthenia gravis, estimating potential sales of about $2 billion.
Goldman Sachs maintains the Buy rating and a <a target="_blank" href="https://www.benzinga.com/quote/AMGN/analyst-ratings" rel="noreferrer noopener">price target of $370</a>.
Looking ahead, attention shifts to Amgen&#8217;s Phase 2 obesity data expected by the end of the year, where positive outcomes could lead to a stock re-rating to account for revenue potential and ease concerns about the upcoming loss of exclusivity in the <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/08/40229568/amgens-mixed-q2-results-highlight-obesity-drug-potential-analysts-focus-shifts-to-u" rel="noreferrer noopener">latter half of the decade</a>.
Earlier this year, Amgen had the data from animal and early-stage human trials of its experimental obesity drug AMG 133 (maridebart cafraglutide)&nbsp;<a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/02/37318123/amgens-upcoming-catalysts-in-2024-set-to-unlock-multi-billion-dollar-markets-says-g" rel="noreferrer noopener">published in Nature Metabolism</a>.
The Journal confirmed the GIPR antagonist and GLP-1R agonist activities in cell-based systems and reported the ability of AMG 133 to reduce body weight and improve metabolic markers in male obese&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/02/36934096/weight-loss-drugs-new-entrant-amgen-to-compete-with-novo-nordisk-eli-lilly-as-investigational-wei" rel="noreferrer noopener">mice and cynomolgus monkeys</a>.&nbsp;
Price Action: AMGN stock is down 4.67% at $315.47 at last check Wednesday.
Photo via Shutterstock
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<li><a href="https://www.benzinga.com/markets/equities/24/09/41029568/masimo-names-interim-ceo-as-activist-board-members-step-in-joe-kiani-exits-amid-legal-clash" target="_blank" rel="noreferrer noopener">Masimo Names Interim CEO As Activist Board Members Step In; Joe Kiani Exits Amid Legal Clash</a>.</li>
</ul>

Analyst Color

Reiteration

AMGN

Amgen's Rocatinlimab Has Commercial Potential Despite Competitive Landscape, Says Goldman Sachs

In an investor update on Tuesday, Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) released data from Phase 3 trials of rocatinlimab and Uplizna (inebilizumab).
HORIZON Phase 3 trial evaluated rocatinlimab for atopic dermatitis (eczema) in 726 patients.
Amgen <a target="_blank" href="https://investors.amgen.com/static-files/a7119a35-06de-497e-ba75-146404c54d95" rel="noreferrer noopener">reported</a> that rocatinlimab outperformed a placebo regarding the severity and extent of the disease.
<ul>
<li>32.8% of rocatinlimab-treated subjects achieved an EASI-75 response at week 24 vs. 13.7% placebo.</li>
<li>19.3% of rocatinlimab-treated subjects achieved a vIGA-AD 0/1 response at week 24 vs. 6.6% placebo.</li>
<li>16.4% of rocatinlimab-treated subjects achieved a rIGA 0/1 response at week 24 vs. 4.9% placebo.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/08/40229568/amgens-mixed-q2-results-highlight-obesity-drug-potential-analysts-focus-shifts-to-u" rel="noreferrer noopener">Amgen&#8217;s Mixed Q2 Results Highlight Obesity Drug Potential, Analysts Focus Shifts To Upcoming Clinical Readouts</a>.
MINT Phase 3 trial of Uplizna in generalized myasthenia gravis showed a clinically meaningful and statistically significant MG-ADL (Myasthenia Gravis Activities of Daily Living) score, a measure of the severity of myasthenia gravis symptoms.
After two doses of Uplizna, MG-ADL score showed an overall improvement of -4.2, versus -1.9 placebo adjusted.
The trial demonstrated a statistically significant improvement in the Quantitative Myasthenia Gravis (QMG) score, a clinical assessment that measures the severity of myasthenia gravis.
QMG score improvement with Uplizna compared to placebo at week 26 was -4.8 overall improvement compared to -2.5 placebo adjusted.
No new safety signals were identified.
STAT News <a target="_blank" href="https://www.statnews.com/2024/09/24/amgen-success-trials-eczema-rocatinlimab-myasthenia-gravis-uplizna-competition-remains-stiff/" rel="noreferrer noopener">noted</a> that though the trials succeeded, the therapies did not beat existing competitors on the market.
51% of adults <a target="_blank" href="https://www.dupixenthcp.com/atopicdermatitis/efficacy-safety/easi-clinical-trial" rel="noreferrer noopener">treated</a> with Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)/ Regeneraon Pharmaceuticals Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Dupixent (dupilumab) achieved EASI-75 vs.&nbsp;15%&nbsp;with placebo at Week 16 in SOLO 1 trial and 44% vs. 12% in SOLO 2 trial.
William Blair noted that rocatinlimab&#8217;s data fell short of expectations, raising concerns about how its clinical profile stacks up in the increasingly competitive atopic dermatitis market, particularly as the broader ROCKET program unfolds.
On the other hand, the Uplizna results for myasthenia gravis exceeded William Blair&#8217;s expectations, indicating a strong market potential for the treatment. Key advantages include its less frequent dosing and potential to reduce steroid use.
The focus will be determining Uplizna&#8217;s position within the myasthenia gravis treatment landscape alongside other options like FcRn, IVIg, complement inhibitors, rituximab, and more. Additionally, the potential for Uplizna&#8217;s CD19-targeting strategy in autoimmune diseases will be closely watched, especially with competitors like Cullinan Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGEM#NASDAQ">CGEM</a>).
Price Action: AMGN stock is trading lower by 2.09% to $324.04 at the last check on Wednesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/general/biotech/24/09/41021471/private-equity-firms-circle-sanofis-consumer-health-business-amid-potential-spinoff" target="_blank" rel="noreferrer noopener">Private Equity Firms Circle Sanofi&#8217;s Consumer Health Business Amid Potential Spinoff</a>.</li>
</ul>
Photo via Shutterstock

CGEM

Amgen's Rocatinlimab Data Beats Placebo In Atopic Dermatitis Trial, But Analyst Says Data Raises Concerns Amid Competitive Market

In October 2023, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced its plans to spin off its consumer healthcare business as the French pharmaceutical company outlined its strategic update to increase investment in its drug-development <a target="_blank" href="https://www.benzinga.com/general/biotech/23/10/35458838/sanofi-goes-the-rival-way-plans-separation-of-consumer-healthcare-unit" rel="noreferrer noopener">pipeline and cut costs</a>.
Sanofi said the spinoff would allow it to increase its focus on innovative medicines and vaccines.
Sanofi&#8217;s consumer health unit boasts a portfolio that includes popular over-the-counter products like Phytoxil cough syrups, Icy Hot pain relief gels, and Dulcolax laxative tablets.&nbsp;
According to a Bloomberg <a target="_blank" href="https://www.bloomberg.com/news/articles/2024-09-24/sanofi-said-to-get-binding-bids-from-cd-r-pai-for-consumer-arm?srnd=prognosis&amp;embedded-checkout=true" rel="noreferrer noopener">report</a>, two private equity firms, Clayton Dubilier &amp; Rice and PAI Partners, made separate bids for Sanofi&#8217;s consumer health division.
The update pushes the European pharma giant closer to one of the largest European deals this year, which could value the unit at 15 billion euros ($16.8 billion) or more, the Bloomberg report added.
The separation is expected to occur by Q4 2024 by creating a publicly listed entity headquartered in France.
In July, Goldman Sachs Group Inc.&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GS#NYSE">GS</a>) and&nbsp;Morgan Stanley (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MS#NYSE">MS</a>) said they were preparing to arrange more than $6.5 billion (6 billion euros) in debt financing for potential buyers interested in acquiring&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39755459/sanofis-20b-consumer-health-unit-sale-goldman-sachs-morgan-stanley-line-up-6-5b-financing" rel="noreferrer noopener">Sanofi&#8217;s&nbsp;consumer health division</a>.
The move highlighted banks&#8217; interest in supporting leveraged buyouts through pre-arranged financing.
Sanofi may opt for a spinoff of its consumer health business if the offers aren&#8217;t appealing, Bloomberg noted, citing sources. A company spokesperson told Bloomberg that Sanofi is evaluating potential separation options, with the earliest possible transaction happening in the fourth quarter of this year, and noted that preparations are progressing as planned.
In November 2023, Sanofi reportedly initiated talks with Rothschild &amp; Co. to explore the possibility of spinning off its consumer health division, which could potentially value the business <a target="_blank" href="https://www.benzinga.com/markets/equities/23/11/35823034/major-buyout-firms-eye-sanofis-consumer-health-division-spinoff-valued-over-20b" rel="noreferrer noopener">at over $20 billion</a>.&nbsp;
Rival pharma giants&nbsp;GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)&nbsp;and&nbsp;Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) split their consumer healthcare units&nbsp;Haleon Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HLN#NYSE">HLN</a>) and Kenvue Inc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KVUE#NYSE">KVUE</a>), respectively.
Price Action: SNY stock closed at $57.62&nbsp;on Tuesday.
Read Next:
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<li><a href="https://www.benzinga.com/general/health-care/24/09/41012667/healthcare-software-giant-epic-systems-hit-with-lawsuit-over-alleged-monopolistic-practices" target="_blank" rel="noreferrer noopener">Healthcare Software Giant Epic Systems Hit With Lawsuit Over Alleged Monopolistic Practices</a>.</li>
</ul>
Photo via Company

Rumors

Media

KVUE

Private Equity Firms Circle Sanofi's Consumer Health Business Amid Potential Spinoff

<a href="https://www.bloomberg.com/news/articles/2024-09-24/sanofi-said-to-get-binding-bids-from-cd-r-pai-for-consumer-arm?srnd=prognosis&amp;embedded-checkout=true" title="https://www.bloomberg.com/news/articles/2024-09-24/sanofi-said-to-get-binding-bids-from-cd-r-pai-for-consumer-arm?srnd=prognosis&amp;embedded-checkout=true">https://www.bloomberg.com/news/articles/2024-09-24/sanofi-said-to-get-binding-bids-from-cd-r-pai-for-consumer-arm?srnd=prognosis&amp;embedded-checkout=true</a>

'Sanofi Gets Binding Bids from CD&R, PAI for Consumer Arm' - Bloomberg

On Monday, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) agreed to make a <a href="https://www.benzinga.com/pressreleases/24/09/g40977996/ventyx-biosciences-announces-27-million-strategic-investment-from-sanofi">$27 million strategic investment</a> in Ventyx Biosciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTYX#NASDAQ">VTYX</a>).
&#8220;We look forward to strengthening our relationship with Sanofi as the VTX3232 clinical programs progress, with data from the Phase 2a trial in patients with early Parkinson&#8217;s disease and data from the Phase 2 trial in subjects with obesity and additional cardiometabolic risk factors, both expected in 2025,&#8221; Ventyx CEO Raju Mohan said.
The company also agreed to grant Sanofi an exclusive right of first negotiation with respect to certain VTX3232 program rights.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/40014856/ventyx-biosciences-inflammatory-bowel-disease-candidate-flunks-in-mid-stage-study-company-looks-f" rel="noreferrer noopener">Ventyx Biosciences&#8217; Inflammatory Bowel Disease Candidate Flunks In Mid-Stage Study, Company Looks For Partner To Pursue It Further</a>.
The proceeds are expected to be sufficient to fund planned operations into at least the second half of 2026.
VTX3232 is geared toward neuroinflammatory and neurodegenerative conditions, including Parkinson&#8217;s disease, cardiometabolic disease, Alzheimer&#8217;s disease, and multiple sclerosis, among others.
In the first quarter of this year, Ventyx announced results from a Phase 1 trial of VTX3232 in adult healthy volunteers where steady-state exposures achieved with once-daily doses of VTX3232 exceeded the interleukin-1β (IL-1β) IC90&nbsp;in both plasma and cerebrospinal fluid over 24 hours.
Current development plans for VTX3232 include a Phase 2a trial in patients with early Parkinson&#8217;s disease and a Phase 2 trial in subjects with obesity and additional cardiometabolic risk factors. Data from both trials are expected in 2025.
Price Action: VTYX stock up 17.9% at $2.71 at last check Monday.
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</ul>
Image: Shutterstock

VTYX

Sanofi Injects $27M In Neurology Drug Developer Ventyx Biosciences

Guidance

IPOs

Sanofi CEO Says No Final Decision Reached Yet On How To Separate Consumer Business, Still Considering Spin-Off, IPO Or Sale-Interview; Interested In Keeping A Stake In Consumer Business Regardless Of Whether It Is Spun Out Or Sold; Hopes To Provide An Update On Consumer Healthcare Process At Q3 Conf. Call In Oct Or Sooner; Not Interested In "Me-Too" GLP-1 Obesity Drug

Sanofi CEO Says Has Some Undisclosed Obesity Drug Development Programs And Is Making Some Investments In Third Parties "That Have A Shot"

Editor&#8217;s Note: The generic name for Sarclisa in the first paragraph stands corrected
On Saturday, the FDA approved Sanofi&#8217;s SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40957635/sanofis-tolebrutinib-delays-disability-progression-in-patients-with-multiple-sclerosis-data-shows" rel="noreferrer noopener">Sanofi&#8217;s Tolebrutinib Delays Disability Progression In Patients With Multiple Sclerosis, Data Shows</a>.
Sarclisa is the first anti-CD38 therapy in combination with standard-of-care VRd to significantly reduce disease progression or death (by 40%) compared to VRd alone for patients with NDMM not eligible for transplant.
This <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-20-22-36-34-2949916" rel="noreferrer noopener">decision </a>marks the third approved indication for Sarclisa in the U.S. and the first approved indication in newly diagnosed patients.
The FDA evaluated Sarclisa for this indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
Sarclisa is also currently approved in more than 50 countries across two indications for people with relapsed or refractory disease.
The FDA approval is based on data from the IMROZ phase 3 study.
Sarclisa-VRd followed by Sarclisa-Rd met the primary endpoint of PFS, significantly reducing the risk of recurrence or death by 40%, compared to VRd followed by Rd.
At a median follow-up of 59.7 months, the median PFS with the Sarclisa-VRd combination was not reached versus 54.3 months with VRd. The&nbsp;estimated PFS rate at 60 months was 63.2% for patients treated with Sarclisa-VRd&nbsp;versus 45.2% for VRd.
Sarclisa-VRd also met several secondary endpoints which demonstrated deep responses in this patient population:
<ul>
<li>Approximately three-quarters (74.7%) of patients treated with Sarclisa-VRd achieved a complete response (CR) or better than 64.1% of patients taking VRd.</li>
<li>More than half (55.5%) of patients treated with Sarclisa-VRd achieved MRD negative CR compared to 40.9% of patients taking VRd.</li>
</ul>
Price Action: At last check on Monday, SNY stock was down 0.50% at $57.34 during the premarket session.
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</ul>
Image by HJBC via Shutterstock

Sanofi's Sarclisa Secures FDA Approval For First-Line Multiple Myeloma, Marking Its Third US Approval (UPDATED)

Ventyx Biosciences  Announces Sanofi Has Agreed To Make A $27M Investment In Co. At An As-Converted Price Of $3.8243 Per Share, Pursuant To Which Sanofi Will Purchase 70,601 Shares Of Series A Non-Voting Convertible Preferred Stock

Novavax: Lack Of Sustainable Revenue Growth Is A Problem

BNY Mellon International Equity Fund Q2 2024 Commentary

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Absci: AI-Driven Platform Could Establish Best-In-Class TL1A Drug Targeting Profile

Thermo Fisher plant making Astra/ Sanofi RSV drug reportedly breached FDA rules

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GSK, Sanofi, CSL said to win $72M U.S. bird flu vaccine contract

GSK, Sanofi, CSL said to win $72M U.S. bird flu vaccine contract (update)

Sanofi consumer health unit bidders revising offers over talc powder concerns - report

Kymera's Protein Degradation Technology: A Promising Bet For Long-Term Biotech Investors

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DNTH

EXPGF

KYMR

LVMHF

LZAGF

LZAGY

NSRGY

NVDA

RCDTF

RCRRF

RHHBF

RHHBY

RHHVF

RICFY

SIEGY

SNYNF

SZCRF

TCCPY

TEVA

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Redington 2_29

BDRX

PowerShares Dynamic Financial Sector Portfolio

Biodexa Takes Aim At Type 1 Diabetes With Innovative Drug Candidate Tolimidone

Earnings

Management

Press Releases

Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for First Quarter 2024

I-Mab Appoints Phillip Dennis, MD, PhD, as Chief Medical Officer

Surging Biotech M&A Reaffirms Massive Opportunity In Rare Disease Drug Development

Vigil Neuroscience Announces $40 Million Strategic Investment from Sanofi

Sanofi ships U.S. influenza vaccines for the 2024/25 season

Ontario Ministry of Health Announces a Universal Public Program with Beyfortus® this RSV Season

Fluzone® High-Dose Quadrivalent vaccine remains preferentially recommended to protect adults 65 years of age and older against influenza

Alzheimer's Disease Diagnostics & Therapeutics Market Driven by Use of Biomarkers and Advancing R&D Activities

Sanofi shipping BEYFORTUS® in US to help protect babies against RSV disease; new manufacturing line approved by FDA

Opinion

Global Cancer Rates Surge as Biotech Innovators Work on New Therapies

ANVS

CRDL

FULC

GTHX

HALO

IMAB

ONCY

TSX:ONC

VIGL

Amneal Pharmaceuticals, Inc. - Class A Common Stock

Amneal Pharmaceuticals

Axsome Therapeutics

AstraZeneca PLC - American Depositary Shares

AstraZeneca

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb

Corcept Therapeutics Incorporated - Common Stock

Corcept Therapeutics

Catalent

Elanco Animal Health Incorporated Common Stock

Elanco Animal Health

GSK plc American Depositary Shares (Each representing two Ordinary Shares)

HUTCHMED (China) Limited - American Depositary Shares

HUTCHMED (China)

Intra-Cellular Therapies Inc. - Common Stock

Intra-Cellular Therapies

Jazz Pharmaceuticals plc - Ordinary Shares

Jazz Pharmaceuticals

Johnson & Johnson

Eli Lilly

Merck & Co

Novo Nordisk

Novartis

Organon

Prestige Consumer Healthcare Inc. Common Stock

Prestige Consumer

Pfizer

Dr. Reddy's Laboratories Ltd Common Stock

Dr Reddy's Laboratories

Royalty Pharma plc - Class A Ordinary Shares

Royalty Pharma

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of Common Stock)

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