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

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

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U.S. CDC Says Since April Confirmed Avian Influenza A(H5) Virus Infections In 52 People In US; Aware Of Human Case Of H5N1 Bird Flu Reported In Canada & Is In Communication With Public Health Agency Of Canada

Some large European and U.S. vaccine maker stocks have fallen in reaction to Robert F. Kennedy Jr.&#8217;s nomination to lead the&nbsp;Department of <a target="_blank" href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower" rel="noreferrer noopener">Health and Human Services</a>.
Kennedy has been known to be against vaccines and has a track record of making false claims about vaccines, including the debunked idea that they cause autism. Scientific studies have <a target="_blank" href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower" rel="noreferrer noopener">debunked this theory</a>.
Also, given his critical stance on mainstream medical practices and vaccines, U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) employees are worried about Kennedy <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42009107/robert-kennedy-poised-to-lead-health-and-human-services-why-fda-nih-officials-are-nervous" rel="noreferrer noopener">being in charge</a>.
Kennedy, who received Trump&#8217;s blessing to &#8220;<a target="_blank" href="https://www.benzinga.com/markets/cannabis/24/11/41828359/could-trumps-go-wild-on-health-invite-to-rfk-jr-drive-changes-for-cannabis-and-psychedelics" rel="noreferrer noopener">go wild on health</a>,&#8221; has stated intentions to overhaul various aspects of the federal health agencies.
In a post on social media, Kennedy <a target="_blank" href="https://x.com/RobertKennedyJr/status/1857198805919138235" rel="noreferrer noopener">said</a>, &#8220;Together we will clean up corruption, stop the revolving door between industry and government, and return our health agencies to their rich tradition of gold-standard, evidence-based science. I will provide Americans with transparency and access to all the data so they can make informed choices for themselves and their families.&#8221;
On Friday, the World Health Organization also defended vaccines describing them as &#8220;absolutely critical&#8221; to global health, adding that many people alive today would not have survived <a href="https://www.benzinga.com/general/biotech/24/11/42006119/who-calls-vaccines-absolutely-critical-as-trumps-appointment-of-rfk-jr-pulls-pzifer-moderna-stocks-downhill" target="_blank" rel="noreferrer noopener">childhood without them</a>.
European vaccine player stocks declined, including&nbsp;GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Valneva SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VALN#NASDAQ">VALN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41715307/biontech-variant-adapted-covid-19-vaccines-do-well-in-q3" rel="noreferrer noopener">BioNTech SE</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>), and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
GSK stock fell after the company reported lower third-quarter sales, which was impacted by an 18% decline <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41624198/gsks-q3-earnings-hit-by-lower-than-expected-vaccine-sales-cautions-lower-revenue-for-2024" rel="noreferrer noopener">in vaccine sales</a>.
COVID-19 vaccine players <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41808252/moderna-q3-revenue-beats-on-updated-covid-19-vaccine-slashes-expenses-for-2024" rel="noreferrer noopener">Moderna Inc</a><a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41808252/moderna-q3-revenue-beats-on-updated-covid-19-vaccine-slashes-expenses-for-2024" rel="noreferrer noopener"> </a>(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41596761/pfizer-q3-earnings-revenue-and-profit-on-heightened-demand-for-paxlovid-expects-10-billion-in-202" rel="noreferrer noopener">Pfizer Inc</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), and BioNTech stock gained when the third quarter earnings surpassed estimates on increased vaccine demand.
Other vaccine players&#8217; stocks that are down include Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) and Inovio Pharmaceuticals, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INO#NASDAQ">INO</a>).
Price Action: GSK stock is down 3.88% at $33.06, BNTX stock is down 5.18%, VALN stock is down 4.24%, AZN stock is down 2.08%, MRK stock is down 3.28%, INO stock is down 9.85% at last check Friday.
Read Next:
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<li><a href="https://www.benzinga.com/government/regulations/24/11/42011035/just-before-bidens-term-ends-taiwan-semiconductor-lands-6-6-billion-in-us-funding-to-build-advanced-chip-plants" target="_blank" rel="noreferrer noopener">Just Before Biden&#8217;s Term Ends, Taiwan Semiconductor Lands $6.6 Billion in US Funding to Build Advanced Chip Plants</a></li>
</ul>
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European And US Vaccine Stocks Are Under Pressure - Here's WHy

On Friday, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals, Inc. (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 (dupilumab) for patients ages 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 <a href="https://www.benzinga.com/pressreleases/24/11/g42000231/press-release-dupixent-sbla-accepted-for-fda-review-for-the-treatment-of-chronic-spontaneous-urtic" target="_blank" rel="noreferrer noopener">antihistamine treatment</a>.
The target action date for the FDA decision is April 18, 2025.
Data from the multi-study LIBERTY-CUPID phase 3 clinical program (<a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2021/2021-07-29-05-00-00-2270858" rel="noreferrer noopener">Study A</a>,&nbsp;<a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-18-06-00-00-2387700" rel="noreferrer noopener">Study B</a>, and&nbsp;<a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-05-00-2944239" rel="noreferrer noopener">Study C</a>) for Dupixent in CSU support the resubmitted supplemental marketing.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41945225/regeneron-sanofis-dupixent-approval-signals-major-treatment-breakthrough-for-smokers-lung-disease" rel="noreferrer noopener">Regeneron/Sanofi&#8217;s Dupixent Approval Signals Major Treatment Breakthrough For Smokers&#8217; Lung Disease</a>
Earlier this year, Japan was the first country in the world to&nbsp;approve&nbsp;and launch Dupixent for adult and adolescent CSU patients based on the results <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">from Study A</a>.
The supplemental marketing adds results from Study C, conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal study in biologic-naïve patients, met its primary and key secondary endpoints, confirming the results of the previous Study A.
Results showed that Dupixent significantly reduced itch and urticaria activity (itch and hives).
In March 2023, the FDA <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2023/2023-03-07-06-00-00-2621670" rel="noreferrer noopener">accepted</a> the supplemental marketing application for Dupixent&nbsp;(dupilumab) to treat adults and adolescents with chronic spontaneous urticaria, with the target action date for the FDA decision of October 22, 2023.
In October 2023, the FDA <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2023/2023-10-20-21-00-00-2764252" rel="noreferrer noopener">issued</a> a Complete Response Letter for the supplemental Biologics License Application and stated that additional efficacy data are required to support approval.
It did not identify any issues with safety or manufacturing.
CSU is a chronic inflammatory skin disease driven partly by type-2 inflammation, which causes sudden hives and recurring itch.
CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control urticaria symptoms.
More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
Price Action: REGN stock closed at $782.51 on Thursday, and SNY stock is up 1.09% at $48.34 during the premarket session at last check Friday.
Read Next:
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<li><a href="https://www.benzinga.com/general/health-care/24/11/41987383/unitedhealths-optum-defends-multi-billion-dollar-amedisys-deal-ensures-competitive-landscape" target="_blank" rel="noreferrer noopener">UnitedHealth&#8217;s Optum Defends Multi-Billion Dollar Amedisys Deal, Ensures Competitive Landscape</a></li>
</ul>
Photo: Shutterstock

REGN

FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria
<ul>
<li>Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity</li>
<li>More than 300,000 people in the US suffer from chronic spontaneous urticaria (CSU) that is inadequately controlled by antihistamines</li>
<li>FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade &nbsp;</li>
</ul>

Dupixent's sBLA Resubmission Accepted By FDA; Phase 3 Data Demonstrate Significant Itch And Hive Reduction For Chronic Urticaria Patients

A new 13F filing from Viking Fund Management reveals which companies the fund bought and sold in the third quarter, including exiting some oil companies ahead of the 2024 election.
Third Quarter Exits: Viking Fund Management sold out of eight stocks completely in the third quarter, including positions in some of the largest oil companies.
Here are the positions exited, as <a href="https://13f.info/13f/000116906924000080/compare/000116906924000006">reported </a>by 13finfo:
<ul>
<li>Marathon Oil (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRO#NYSE">MRO</a>)</li>
<li>Shell PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SHEL#NYSE">SHEL</a>)</li>
<li>SM Energy Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SM#NYSE">SM</a>)</li>
<li>Southern Copper Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SCCO#NYSE">SCCO</a>)</li>
<li>Sociedad Quimica y Minera (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SQM#NYSE">SQM</a>)</li>
<li>Murphy USA (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MUSA#NYSE">MUSA</a>)</li>
<li>Sanofi SA (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NYSE">SNY</a>)</li>
<li>Cactus Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WHD#NYSE">WHD</a>)</li>
</ul>
Third Quarter New Positions: The following were the new stocks added to the fund in the third quarter, ranked in size by the dollar value at the end of the quarter.
<ul>
<li>Kodiak Gas Services (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KGS#NYSE">KGS</a>)</li>
<li>EQT Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EQT#NYSE">EQT</a>)</li>
<li>HF Sinclair Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DINO#NYSE">DINO</a>)</li>
<li>Weatherford International (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WFRD#NASDAQ">WFRD</a>)</li>
<li>NRG Energy (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NRG#NYSE">NRG</a>)</li>
<li>Vertiv Holdings (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VRT#NYSE">VRT</a>)</li>
<li>Chart Industries (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GTLS#NYSE">GTLS</a>)</li>
<li>Vistra Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VST#NYSE">VST</a>)</li>
<li>United Microelectronics (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UMC#NYSE">UMC</a>)</li>
<li>Eversource Energy (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ES#NYSE">ES</a>)</li>
<li>Portland General Electric (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/POR#NYSE">POR</a>)</li>
<li>Restaurant Brands International (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QSR#NYSE">QSR</a>)</li>
<li>Nutrien (NTR.TO – Canada)</li>
</ul>
 Big Moves: The fund made several changes to its existing positions alongside the new positions and exited positions.
Here are the biggest additions in the quarter to existing stakes:
<ul>
<li>Civitas Resources (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CIVI#NYSE">CIVI</a>): +16,900%</li>
<li>Broadcom Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVGO#NASDAQ">AVGO</a>): +882%</li>
<li>LyondellBassell Industries (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LYB#NYSE">LYB</a>): +400%</li>
<li>Rio Tinto PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RIO#NYSE">RIO</a>): +386%</li>
<li>Dow Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DOW#NYSE">DOW</a>): +200%</li>
</ul>
Here are the biggest position cuts during the quarter to existing stakes:
<ul>
<li>Texas Pacific Land (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TPL#NYSE">TPL</a>): -60%</li>
<li>Tesla Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>): -50%</li>
<li>Haliburton Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HAL#NYSE">HAL</a>): -40%</li>
<li>ExxonMobil (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XOM#NYSE">XOM</a>): -36%</li>
<li>Ovintiv (OVV.TO – Canada): -33%</li>
</ul>
Why It's Important: At the end of the quarter, these are the fund's largest positions ranked by dollar value and the percentage they make up of the fund:
<ul>
<li>Broadcom: $27.96 million, 4.5%</li>
<li>AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>): $24.88 million, 4.0%</li>
<li>NextEra Energy (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NEE#NYSE">NEE</a>): $22.65 million, 3.7%</li>
<li>Entergy Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ETR#NYSE">ETR</a>): $16.27 million, 2.6%</li>
<li>BlackRock Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BLK#NYSE">BLK</a>): $14.24 million, 2.3%</li>
</ul>
The fund added significantly to its position in Broadcom, which remains the largest holding.
The quarter saw the sale of several oil stocks, but the fund opened new positions in several energy names in the quarter.
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Viking Fund Management Sells Big Oil Stocks In Q3, Cuts Tesla Position In Half, Adds To Largest Position Broadcom

Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma
<ul>
<li>Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination with VRd significantly improved progression-free survival, compared to standard-of-care VRd alone</li>
<li>If approved, Sarclisa would be the first anti-CD38 therapy in the EU available for use in combination with VRd for adult patients with transplant-ineligible NDMM</li>
</ul>
 Paris, November 14, 2024. The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). A final decision is expected in the coming months.

Sarclisa Recommended For EU Approval By The CHMP To Treat Transplant-Ineligible Newly Diagnosed Multiple Myeloma; Sarclisa Recommended For EU Approval By CHMP; Sarclisa Could Be First Anti-CD38 Therapy In EU For NDMM

After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment, patients now have new options.
Regeneron Pharmaceuticals Inc (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 recently gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis <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">seven years ago</a>.
This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow.
COPD often manifests as chronic bronchitis and emphysema, typically developing from prolonged exposure to irritants like cigarette smoke, air pollution, or occupational dust.
Also Read: <a target="_blank" href="https://www.benzinga.com/markets/equities/24/06/39312759/regenerons-dupixent-copd-sales-to-reach-20b-by-2026-analyst-sees-larger-addressable-market" rel="noreferrer noopener">Regeneron&#8217;s Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market</a>
The condition impacts millions globally, with a 2023 analysis by DelveInsight <a target="_blank" href="https://www.prnewswire.com/news-releases/sanofiregeneron-pharmaceuticals-dupixent-approval-marks-a-significant-shift-in-chronic-obstructive-pulmonary-disease-treatment-landscape--delveinsight-302302232.html" rel="noreferrer noopener">reporting</a> around 44 million diagnosed cases across seven major markets, with projections of continued growth at a 1.4% CAGR through 2034.
COPD management typically involves medications like bronchodilators, which ease breathing by relaxing airway muscles.
These drugs, often used in inhalers, can include steroids to reduce inflammation in severe cases. Common options include short—and long-acting bronchodilators like Albuterol, Ipratropium, and Aclidinium. LABAs and LAMAs are also prevalent, with combinations such as LABA+ICS (e.g., AstraZeneca Plc&#8217;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) Symbicort, GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Advair) and LABA+LAMA (e.g., GSK&#8217;s Anoro Ellipta, Boehringer Ingelheim&#8217;s Stiolto Respimat) available for comprehensive treatment.
The introduction of Dupixent changes the treatment landscape by specifically targeting type 2 inflammation pathways (IL-4 and IL-13), which play a role in COPD patients with elevated eosinophils prone to frequent exacerbations.
The Phase 3 BOREAS trial demonstrated that DUPIXENT reduced moderate-to-severe exacerbations by 30% over 52 weeks and improved lung function, with prebronchodilator FEV1 increasing by 160 mL compared to 77 mL in the placebo group.
The drug also had a favorable safety profile, indicating its potential as a game-changer for those with type 2 inflammation.
Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron&#8217;s itepekimab, AstraZeneca&#8217;s benralizumab, Amgen Inc NASDAQ: AMGN/AstraZeneca&#8217;s tezepelumab, and GSK&#8217;s mepolizumab are in development, promising more options to transform COPD management.
On Wednesday, Regeneron announced that new and updated data from its hematology pipeline will be presented in 23 abstracts at the American Society of Hematology <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g41934824/regeneron-to-highlight-pioneering-pipeline-progress-across-multiple-modalities-spanning-10-types-o" rel="noreferrer noopener">2024 Annual Meeting</a>.
Price Action: REGN stock traded lower by 0.98% to $812.92 at the last check on Wednesday.
Read Next:
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<li><a href="https://www.benzinga.com/government/regulations/24/11/41939018/japan-increases-semiconductor-funding-as-us-trade-policies-pressure-taiwan-semiconductor" target="_blank" rel="noreferrer noopener">Japan Increases Semiconductor Funding As US Trade Policies Pressure Taiwan Semiconductor</a></li>
</ul>
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Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease

Ahead of World Diabetes Day, Doctors Without Borders/Médecins Sans Frontières (MSF) called for all insulin manufacturers to provide injection pen devices at $1 per pen.
The humanitarian organization <a target="_blank" href="https://www.doctorswithoutborders.org/latest/eli-lilly-novo-nordisk-and-sanofi-must-make-insulin-pens-available-1-each" rel="noreferrer noopener">emphasized</a> that this would help ensure access to life-saving treatment for millions in low- and middle-income countries, where many struggle to afford diabetes care.
MSF highlighted that Eli Lilly And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), which dominate the global insulin market, have the power to set high <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40731728/eli-lillys-once-weekly-insulin-shows-non-inferior-blood-sugar-reduction-vs-frequently-used-daily-" rel="noreferrer noopener">prices that restrict access</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41855578/bristol-myers-squibb-leads-biopharma-recovery-with-almost-25-growth-in-market-cap-but-novo-nordisk-and-lilly-suffer-market-setbacks" rel="noreferrer noopener">Bristol-Myers Squibb Leads Biopharma Recovery With Almost 25% Growth In Market Cap, But Novo Nordisk And Lilly Suffer Market Setbacks</a>
According to MSF, data published in&nbsp;JAMA Network Open&nbsp;shows that insulin pens could be produced for as little as $0.94 per unit and remain profitable, yet current prices far exceed this figure.
For instance, a pen costs $1.99 in South Africa, $5.77 in India, $14.00 in the Philippines, and $90.69 in the U.S.
Dr. Helen Bygrave, an advisor for MSF's Access Campaign, underscored the disparity by recalling the initial intentions of the scientists who discovered insulin. "Over 100 years ago, they sold the patent for just $1 to ensure global access. Now, only about half of those who need insulin can access it," she said.
She stated that the corporate control by Eli Lilly, Novo Nordisk, and Sanofi has led to a "double standard" that hinders equitable diabetes treatment.
In July, the FDA rejected Novo Nordisk's BLA filing for the once-<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39732571/fda-rejects-novo-nordisks-weekly-insulin-requests-information-related-to-manufacturing-process-ty" rel="noreferrer noopener">weekly insulin icodec</a>.
Insulin pens, known for their dosing accuracy and user-friendly design, have been preferred by 82% of surveyed diabetes patients due to their convenience and less invasive administration compared to vials and syringes.
Recently, Novo Nordisk decided to cease insulin pen production to prioritize its GLP-1 medications for diabetes and obesity, like <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41775675/ozempicwegovy-maker-maintains-q3-sales-growth-on-booming-demand" rel="noreferrer noopener">Ozempic and Wegovy</a>.
This shift, motivated by profit margins in wealthier markets, could force many patients back to using syringes and vials.
South Africa, which transitioned to insulin pens in its public sector in 2014, recently faced a shortage that led to rationing when Novo Nordisk paused the supply of human insulin pens to the government.
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Photo by towfiqu barbhuiya via unsplash

Humanitarian Organization Criticizes Eli Lilly, Novo Nordisk And Sanofi Of Having 'Double Standards' For High Insulin Price

Legal

MNOV

MediciNova Says Notified By Sanofi That Sanofi/Novartis Litigation Was Settled; Says It Is Entitled To Receive Certain Amount Of Monetary Damages Through This Settlement

The biopharmaceutical sector showed signs of recovery in the third quarter of 2024, fueled by increased investor optimism following the U.S. Federal Reserve&#8217;s interest rate cuts in September. 
According to GlobalData, the top 20 global biopharmaceutical companies <a href="https://www.globaldata.com/media/business-fundamentals/top-20-global-biopharmaceutical-companies-witness-2-growth-in-market-capitalization-in-q3-2024-reveals-globaldata/#:~:text=As%20a%20result%2C%20the%20top,data%20analytics%20and%20research%20company.">saw</a> a 2% rise in their combined market capitalization, reaching $4.3 trillion by the end of September, up from $4.2 trillion in June. 
This rebound highlights the industry&#8217;s potential for growth despite challenges earlier in the year.
Bristol-Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) led the market with the largest increase in capitalization, which surged by 24.6% to $105 billion. This was largely driven by advancements in its pipeline, notably the FDA&#8217;s approval of its antipsychotic drug, Cobenfy, for treating <a href="https://www.benzinga.com/general/biotech/24/09/41064867/schizophrenia-treatment-revolution-fda-approves-bristol-myers-squibb-cobenfy-as-new-class-of-trea">schizophrenia in September 2024</a>. 
Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) also <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/11/41819570/hiv-drugmaker-gilead-reports-strongest-quarterly-performance-of-2024-analysts-boost">posted impressive growth</a>, rising 22.1% in market value, thanks to the accelerated FDA approval of Livdelzi, a treatment for <a href="https://www.benzinga.com/general/biotech/24/08/40394698/fda-approves-gileads-seladelpar-for-inflammatory-liver-disease-acquired-via-4b-cymabay-deal">primary biliary cholangitis</a>, as well as the approval of its antibody-drug conjugate, Trodelvy, for HR-/HER2- breast cancer in Japan.
Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) experienced a 19.2% jump in market capitalization, largely fueled by its <a href="https://www.benzinga.com/general/biotech/24/10/41541274/sanofi-earns-5b-q3-core-profit-on-strong-dupixent-and-vaccine-sales-raises-2024-forecast">flagship drug Dupixent</a>. The drug&#8217;s strong performance in the treatment of conditions such as asthma and atopic dermatitis, coupled with its recent EMA and FDA approvals for chronic obstructive pulmonary disease (COPD), further <a href="https://www.benzinga.com/general/biotech/24/09/41069388/fda-approves-regeneronsanofis-blockbuster-dupixent-for-smokers-lung-disease">boosted Sanofi&#8217;s standing</a>. 
Similarly, AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) saw a 15.2% increase in its market cap, driven by the continued success of its immunology drugs—Humira, Skyrizi, and Rinvoq—which together generated nearly $7 billion <a href="https://www.benzinga.com/general/biotech/24/07/39960414/abbvies-q2-earnings-beat-estimates-raises-annual-profit-on-strong-sales-from-newer-immunology-and">in Q2 2024 sales</a>.
Alnylam Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALNY#NASDAQ">ALNY</a>) joined the top 20 biopharmaceutical companies with a 14.9% rise in its market value, following its RNAi drug vutrisiran's positive results in treating ATTR <a href="https://www.benzinga.com/general/biotech/24/08/40652720/alnylam-pharmaceuticals-stock-falls-after-detailed-vutrisiran-data-for-a-condition-with-stiff-hea">amyloidosis with cardiomyopathy</a>. 
Roche Holdings AG's (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) market capitalization grew by 13.8%, spurred by the FDA&#8217;s approval of two key products, Ocrevus Zunovo for multiple sclerosis and Tecentriq Hybreza for oncology indications, the latter being the only approved subcutaneous <a href="https://www.benzinga.com/general/biotech/24/08/40652720/alnylam-pharmaceuticals-stock-falls-after-detailed-vutrisiran-data-for-a-condition-with-stiff-hea">PD-L1 inhibitor available</a>.
On the downside, Wegovy maker Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) saw an 18.2% drop in its market cap after the FDA rejected its BLA filing for the once-<a href="https://www.benzinga.com/general/biotech/24/07/39732571/fda-rejects-novo-nordisks-weekly-insulin-requests-information-related-to-manufacturing-process-ty">weekly insulin icodec</a>.
Similarly, Eli Lilly &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) reported a slight decline of 2.1%, though both companies retained their leadership in diabetes and <a href="https://www.benzinga.com/general/biotech/24/10/41622207/eli-lilly-q3-earnings-mounjaro-sales-more-than-double-takes-2-98-billion-hit-to-profit-cuts-annua">weight loss drugs</a>. 
Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) also faced a 8.2% fall in market value, largely due to disappointing sales of its HPV vaccine, <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/11/41693101/mercks-gardasil-shot-challenges-to-continue-analysts-optimistic-for-newly-approved-">Gardasil, in China</a>.
&nbsp;"The biopharmaceutical industry is poised for a recovery, fueled by multiple FDA approvals leading to a rebound in companies that have seen declines in market capitalization in previous quarters, such as Gilead Sciences and Bristol-Myers Squibb,&#8221; says GlobalData analyst.
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Image Via Shutterstock

ALNY

GILD

RHHBY

Bristol-Myers Squibb Leads Biopharma Recovery With Almost 25% Growth In Market Cap, But Novo Nordisk And Lilly Suffer Market Setbacks

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one year
Dupixent is the first-ever medicine in the EU indicated to treat these young patients, who persistently struggle to eat at a critical stage in life where growth is crucial

Regeneron And Sanofi's Dupixent Receives EU Approval For Children With Eosinophilic Esophagitis, Offering New Hope For Ages 1 To 11

Just two weeks ago, Upstream Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UPB#NASDAQ">UPB</a>) closed its upsized initial public offering (IPO) of 17.25 million shares at $17 per share, with gross proceeds of <a href="https://www.benzinga.com/pressreleases/24/10/g41344387/upstream-bio-announces-closing-of-293-million-upsized-initial-public-offering-including-full-exerc" target="_blank" rel="noreferrer noopener">approximately $293 million</a>.
Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases with an initial focus on severe respiratory disorders.
<ul>
<li>Piper Sandler initiated coverage on Upstream Bio with an Overweight rating and a <a href="https://www.benzinga.com/quote/UPB/analyst-ratings" target="_blank" rel="noreferrer noopener">price target of $75</a>.</li>
<li>William Blair has also initiated coverage of Upstream Bio with an Outperform rating </li>
</ul>
Piper Sandler noted the company&#8217;s lead program, verekitug, has a differentiated mechanism of action that targets the TSLP receptor vs. ligand.
The TSLP ligand has been de-risked by AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) / Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) Tezspire&#8217;s 2021 approval in severe asthma, the analyst says. It represents a rapidly growing biologic market opportunity of over $7.5 billion.
Piper analyst writes, &#8220;verekitug&#8217;s key advantage is its durability given its high potency, enabling Q12W dosing and potentially up to Q24W dosing, which is significantly lower compared to other biologics such as Tezspire (Q4W dosing) and Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) / Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent (Q2W dosing).
William Blair also based its rating on the blockbuster potential of verekitug in large indications, including asthma and chronic obstructive pulmonary disease (COPD).
&#8220;The analyst writes that &#8220;Verekitug has the potential to deliver differentiated efficacy and longer dosing intervals than currently approved biologics for the treatment of asthma, most notably the TSLP antibody Tezspire, which targets the ligand.
William Blair writes that demonstrating clinical efficacy at least comparable to Tezspire, with dosing intervals of every three to six months, could position the therapy as a blockbuster, aligning with patient preferences for fewer doses.
However, early preclinical and clinical data for verekitug indicate a potential for even greater efficacy than Tezspire, which could exceed current baseline expectations.
Price Action: Upstream Bio stock is up 12.5% at $28.30 at last check Tuesday.
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</ul>

Analyst Color

Initiation

Analyst Ratings

AMGN

Upstream Bio Is New On NASDAQ, Can Potentially Beat AstraZeneca's Asthma Drug On Efficacy, Analysts Say

On Thursday, Lexicon Pharmaceuticals Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LXRX#NASDAQ">LXRX</a>)&nbsp;announced the outcome of the FDA&#8217;s Endocrinologic and Metabolic Drugs Advisory Committee Meeting to review the company&#8217;s New Drug Application (NDA) <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41667604/lexicon-announces-outcome-of-fda-advisory-committee-for-zynquista-sotagliflozin-as-an-adjunct-to-i" rel="noreferrer noopener">for Zynquista (sotagliflozin)</a>.
The company is seeking approval for the oral SGLT1/SGLT2 inhibitor as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).
The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks, as having an estimated glomerular filtration rate (eGFR)&nbsp;&gt;45 to &lt;60 mL/min.1.73 m2&nbsp;or eGFR&nbsp;&gt;60 mL/min/1.73 m2&nbsp;and urine albumin-to-creatinine ratio (uACR)&nbsp;&gt;&nbsp;30mg/g.&nbsp;
As part of the discussion, certain committee members expressed support for sotagliflozin in alternative sub-populations of people with T1D and CKD, where they believed the benefits potentially outweigh the risks.
As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 20.
The FDA approved Sotagliflozin, branded as Inpefa, in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other <a target="_blank" href="https://www.benzinga.com/pressreleases/23/05/g32603118/lexicon-announces-fda-approval-of-inpefa-sotagliflozin-for-treatment-of-heart-failure" rel="noreferrer noopener">cardiovascular risk factors</a>.
In 2019, the FDA issued a complete response letter (CRL) regarding the NDA for sotagliflozin for type 1 diabetes. Despite FDA rejection, the European Medicines Agency <a target="_blank" href="https://www.lexpharma.com/media-center/news/zynquista-now-approved-in-the-european-union-for-treatment-of-adults-with-type-1-diabetes" rel="noreferrer noopener">approved</a> the drug in April 2019, covering TID patients who could not achieve adequate glycemic control despite optimal insulin therapy.
In 2021, at Lexicon's request, the FDA issued a public Notice of Opportunity for Hearing (NOOH) on whether there were grounds for denying such approval.
Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance to discuss a path forward for resubmission and potential approval of the NDA.
Lexicon Pharmaceuticals resubmitted its NDA for sotagliflozin in June. The company anticipated a six-month review and a potential <a target="_blank" href="https://www.benzinga.com/pressreleases/24/06/g39430661/lexicon-pharmaceuticals-resubmits-sotagliflozin-nda-for-type-1-diabetes" rel="noreferrer noopener">launch in early 2025</a>.
Also, in 2019, after four years of collaboration, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) <a target="_blank" href="https://www.lexpharma.com/media-center/news/lexicon-pharmaceuticals-announces-termination-of-alliance-and-settlement-with-sanofi" rel="noreferrer noopener">terminated</a> the sotagliflozin-related agreement and paid Lexicon Pharmaceuticals $260 million.
Two weeks ago, Viatris Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTRS#NASDAQ">VTRS</a>) obtained an exclusive license from Lexicon to commercialize sotagliflozin in all indications outside of the U.S. and Europe. Lexicon retains sole commercialization rights for sotagliflozin in all indications in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41368750/lexicon-announces-exclusive-licensing-agreement-with-viatris-for-sotagliflozin-in-all-markets-outs" rel="noreferrer noopener">the U.S. and Europe</a>.
Price Action: LXRX stock is down 38.46% at $1.22 during the premarket session at last check Friday.
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Photo: Shutterstock

LXRX

VTRS

FDA Panel Rejects Lexicon's Zynquista For Type 1 Diabetes

On Thursday,&nbsp;Regeneron Pharmaceuticals&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>)&nbsp;reported third-quarter adjusted EPS of $12.46, up 8% year-over-year, beating the&nbsp;<a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $11.69</a>.
The company reported sales of $3.72 billion, up 11%, beating the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/g41647880/regeneron-reports-third-quarter-2024-financial-and-operating-results" rel="noreferrer noopener">consensus of $3.67 billion</a>.
&#8220;Regeneron&nbsp;had a strong third quarter marked by 11% revenue growth. We continued to deepen the impact of our commercialized medicines this quarter, with ongoing leadership for our retinal franchise, expanded global reach of Libtayo, and notable growth from Dupixent,&#8221; said&nbsp;Leonard S. Schleifer, Board co-Chair, President and Chief Executive Officer of&nbsp;Regeneron.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41208078/regeneron-chief-flags-health-risks-with-popular-weight-loss-medications-like-ozempic-says-company" rel="noreferrer noopener">Regeneron Chief Flags Health Risks with Popular Weight-Loss Medications Like Ozempic, Says Company Targets Muscle Preservation For Its Obesity Drugs</a>
&#8220;Our strong third quarter financial performance was highlighted by double-digit revenue growth and continued investment in our growing pipeline,&#8221; said Christopher Fenimore, Senior Vice President, Finance and Chief Financial Officer of Regeneron.
Third quarter 2024 U.S. net sales for Eylea HD&nbsp;and Eylea&nbsp;increased 3% versus third quarter 2023 to $1.54&nbsp;billion, including $392 million from Eylea HD.
A lower net selling price adversely impacted the net product sales of EYLEA in the third quarter of 2024.
Libtayo&nbsp;global net sales increased by 25% to $289 million.
Sanofi SA&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) collaboration revenue increased from $1.06 billion to $1.26 billion.
The company said its obesity clinical program is now enrolling.
In its earnings <a target="_blank" href="https://investor.regeneron.com/static-files/4ac68b22-7abe-4d1f-a15a-2a9b739cc935" rel="noreferrer noopener">presentation</a>, Regeneron said Phase 2 study to investigate if addition of trevogrumab (anti-myostatin) to Novo Nordisk A/S&#8216; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) semaglutide with and without garetosmab (antiactivin A) improves the quality of weight loss and/or improves maintenance of weight loss post semaglutide discontinuation.
Safety and tolerability data for high-dose trevogrumab in healthy volunteers showed no new safety signals.
The company is on track to complete enrollment by year-end 2024; results for both primary endpoints are expected in 2H25.
Price Action: REGN stock is down 10.7% at $824.28 at last check Thursday.
Photo via Shutterstock
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Earnings

Why Is Regeneron Pharmaceuticals Stock Trading Lower Today?

<a href="https://www.aphis.usda.gov/news/agency-announcements/federal-state-veterinary-agencies-share-update-hpai-detections-oregon" title="https://www.aphis.usda.gov/news/agency-announcements/federal-state-veterinary-agencies-share-update-hpai-detections-oregon">https://www.aphis.usda.gov/news/agency-announcements/federal-state-veterinary-agencies-share-update-hpai-detections-oregon</a>

USDA Says H5N1 Bird Flu Detected In Swine For The First Time In U.S. In Oregon Backyard Farm; There Is No Concern About Safety Of The Nation's Pork Supply As A Result Of This Finding On HPAI Detections In Oregon Backyard Farm

USDA To Begin Bulk Milk Testing For Bird Flu Nationwide Following Pressure From Industry And Veterinary Groups; New Effort Aims To Curb Rapid Spread Among Dairy Herds

<a href="https://www.cdc.gov/bird-flu/spotlights/bird-flu-response-10-29-24.html#:~:text=Since%20April%202024%2C%20CDC%2C%20working,infected%20dairy%20cows12" title="https://www.cdc.gov/bird-flu/spotlights/bird-flu-response-10-29-24.html#:~:text=Since%20April%202024%2C%20CDC%2C%20working,infected%20dairy%20cows12">https://www.cdc.gov/bird-flu/spotlights/bird-flu-response-10-29-24.html#:~:text=Since%20April%202024%2C%20CDC%2C%20working,infected%20dairy%20cows12</a>.

Macro Notification

US CDC Reports 36 H5 Bird Flu Cases In U.S. Since April; Six Cases In Washington Poultry Workers Confirmed Last Week; No Person-To-Person Spread Detected; Public Risk Remains Low But Higher For Those Exposed To Infected Animals; 15 Cases Linked To Infected Poultry And 20 To Sick Dairy Cows

Beyfortus is the first long-acting antibody approved in Canada for the prevention of RSV lower respiratory tract disease in newborns and infants through their first RSV season.

Sanofi Says Beyfortus Will Be Broadly Available For Babies Born In Ontario, Quebec, Nunavut, Northwest Territories, And The Yukon This Fall

On Friday, Eli Lilly and Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) revealed new results from the Phase 3b ADapt study of Ebglyss (lebrikizumab), which will be presented at the Fall <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/n41540619/lillys-ebglyss-lebrikizumab-lbkz-demonstrated-meaningful-improvement-in-skin-clearance-and-itch-re" rel="noreferrer noopener">Clinical Dermatology Conference</a>.
The results show that Ebglyss improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) / Regeneron Pharmaceuticals Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Dupixent (dupilumab).
The study&#8217;s primary endpoint was measured by at least a 75% improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks, which evaluates the extent and severity of the skin disease.
Secondary endpoints at 16 and 24 weeks included Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin with a reduction of at least two points from baseline and at least a four-point improvement in Pruritus NRS from baseline.
With Ebglyss, 57% of patients in Week 16 and 60% in Week 24 who had previously been treated with dupilumab achieved EASI-75.
In addition, 46% of patients who were inadequate responders to dupilumab achieved EASI-75 response with Ebglyss at Week 16.
53% and 62% of ADapt patients who discontinued dupilumab and began treatment with Ebglyss also experienced itch relief (Pruritus NRS) with at least a four-point improvement from baseline at Week 16 and Week 24, respectively.
Patients in this study saw improvements in difficult-to-treat areas when treated with Ebglyss.
52% treated with Ebglyss saw clear or almost clear face dermatitis at Week 24.
Among patients with moderate-to-severe hand dermatitis at baseline, the modified total lesion-symptom score, which measures the extent and severity of hand dermatitis, decreased by 75 percent at Week 24.
Less than 6% of patients treated with Ebglyss experienced an adverse event that led to treatment discontinuation.
Last month, the FDA approved Ebglyss, a targeted IL-13 inhibitor, for adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40884197/eli-lilly-scores-fda-approval-for-eczema-treatment-ebglyss" rel="noreferrer noopener">topical prescription therapies</a>.
Ebglyss was also approved in the European Union in 2023 and Japan in January 2024, with additional markets expected later this year.
Price Action: LLY stock is up 0.32% at $894.15 at last check Friday.
Image via Shutterstock
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Equities

Eli Lilly's Newly FDA-Approved Eczema Drug Improves Skin And Itch In Patients Previously Treated With Sanofi/Regeneron's Dupixent

WIIM

Sanofi shares are trading higher after the company reported a year-over-year increase in Q3 adjusted EPS results and better-than-expected Q3 sales results.

Sanofi: Diverse Drug Portfolio And Future Pipeline, 4% Dividend Yield Looks Attractive

Novavax Q3 Earnings Disappoint, But A Turnaround May Be Underway

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Biotech Alert: Searches spiking for these stocks today

Vaccine makers close lower amid reports RFK Jr may head HHS

Vaccine makers close lower amid reports RFK Jr may head HHS (update)

FEZ: A Trump Trade Alternative?

Deutsche Bank downgraded GSK (GSK) to Hold from Buy with a price target of 1,350 GBp, down from 1,700 GBp. The firm cites President-elect Donald Tr...

Deutsche downgrades GSK to Hold on Trump's RFK nomination

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application...

Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review

Regeneron, Sanofi say resubmitted application to expand Dupixent label accepted in U.S.

Sanofi (SNY) has released an update. Sanofi's Sarclisa received a positive recommendation from the EMA's CHMP for treating newly diagnosed multiple...

Sanofi's Sarclisa Nears EU Approval for Myeloma

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

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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

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Global Cancer Rates Surge as Biotech Innovators Work on New Therapies

Sanofi commits $18 million to Howard University College of Medicine, Meharry Medical College, and Morehouse School of Medicine to increase diversity in clinical studies

FLUBLOK® (Influenza Vaccine) US label updated with one of Sanofi's largest flu vaccine safety studies in pregnant individuals

Beyfortus® immunization to protect infants from RSV has begun

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