Sanofi (NASDAQ:SNY) Stock, Quote.Headers.trade-ideas

Sanofi

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. About 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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Novartis&#39; new data for Kesimpta showed reduced disability progression in relapsing multiple sclerosis patients. Continuous Kesimpta treatment led to better outcomes compared to those who switched from Aubagio.

Novartis&#39; Multiple Sclerosis Drug Data Shows Most Patients Remain With No Disability Progression For Up To Six Years

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REGN

Regeneron and Sanofi&#39;s Dupixent achieves positive Phase 3 results for chronic spontaneous urticaria, meeting key endpoints.

Sanofi, Regeneron Drug Dupixent Shows Successful Treatment Of Patients With Inflammatory Skin Disease

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GSK&#39;s (NYSE: GSK) phase III study evaluating its blockbuster drug Nucala (mepolizumab), an anti-IL5 biologic, for treating chronic obstructive pulmonary disease (COPD), met its primary endpoint.

GSK&#39;s Respiratory Drug Nucala Meets Goal in COPD Study

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

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Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) released new data Wednesday from the ALITHIOS open-label extension study.
Data show first-line Kesimpta&nbsp;(ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Aubagio (teriflunomide).
These <a target="_blank" href="https://www.novartis.com/news/media-releases/new-novartis-data-relapsing-ms-reinforce-benefits-kesimpta-first-line-and-switch-patients" rel="noreferrer noopener">data</a> will be presented at the European Committee for Treatment and Research in Multiple Sclerosis.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40738489/goldman-sachs-shifts-stance-on-novartis-cites-lack-of-near-term-catalysts" rel="noreferrer noopener">Goldman Sachs Shifts Stance On Novartis, Cites Lack Of Near-Term Catalysts</a>.
Data from the overall ALITHIOS study population showed that continuous use of Kesimpta was associated with numerically fewer six-month confirmed disability worsening (6mCDW) and progression independent of relapse activity (6mPIRA) events up to six years compared to those who switched from teriflunomide.
RDTN patients receiving continuous Kesimpta were more likely to remain free from 6mCDW than those who switched to Kesimpta from teriflunomide (83.4% vs. 76.3%).
RDTN patients receiving continuous Kesimpta were also more likely to be free of 6mPIRA vs. switching from teriflunomide (88.9% vs. 83.3%).
A separate U.S.-based single-arm OLIKOS Phase 3b study showed that at 12 months, all clinically stable RMS patients who switched from intravenous (IV) anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions, a commonly used marker of disease activity, compared to baseline.
Tuesday, the FDA <a target="_blank" href="https://www.novartis.com/news/media-releases/fda-approves-novartis-kisqali-reduce-risk-recurrence-people-hrher2-early-breast-cancer" rel="noreferrer noopener">approved</a> Novartis&#8217; Kisqali&nbsp;(ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease.
The approval is based on results from the pivotal Phase 3 NATALEE trial, which showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence.
Price Action: Novartis stock is down 0.1% at $115.85 at last check Wednesday.
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Image: Wikimedia Commons

Novartis' Multiple Sclerosis Drug Data Shows Most Patients Remain With No Disability Progression For Up To Six Years

Sanofi Says Shipping BEYFORTUS 50mg And 100mg Injection Doses To Private Healthcare Providers And To The Centers For Disease Control And Prevention For Its Vaccines For Children

Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP &nbsp;
Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps
Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions
TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent&#xAE; (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial <a href="https://www.globenewswire.com/Tracker?data=w90qF6GCmljM0YZvlQbqWrdmYKa6Yk2a2He2kZGHCkM1z8bxT5apbQF0ZFvOlHsJGCzOw4Q18UVvLrraOBhx6pU5SX-1xYJtVuCMBmh2laljyFvc3QLssszKh-HRJ4G9UfRk1kwinnS7Mo6GbRwBGfkjlR6_JN1f4TqjudOMQH7-Y_O1__aC9d4tMQEizUmvdJy6R4Aa9s-yJWfBpdiXVQ==">June 2019</a> FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Regeneron Pharmaceuticals And Sanofi Announce FDA Approval For Dupixent In The U.S. As First And Only Treatment For Adolescents With Chronic Rhinosinusitis With Nasal Polyps

This approval expands the initial Health Canada Notice of Compliance for eosinophilic esophagitis in May 2023 for patients aged 12 years and older, weighing at least 40 kg.

Health Canada Has Issued A Notice Of Compliance For Sanofi/Regeneron Dupixent (Dupilumab Injection) For The Treatment Of Patients Aged 1 Year And Older, Weighing At Least 15 Kg, With Eosinophilic Esophagitis

Under the licensing agreement, Sanofi will be responsible for the global commercialization of AlphaMedix, while Orano Med will be responsible for the manufacturing of AlphaMedix through its global industrial platform currently under development

Contracts

Sanofi Has Collaborated With Radiomedix And Orano Med For Alphamedix (212Pb-DOTAMTATE), For Neuroendocrine Tumors, Radiomedix And Orano Med Will Receive An Upfront Payment Of €100M And Up To €220M In Sales Milestones

<ul>
<li>Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancer</li>
</ul>

Sanofi, RadioMedix, And Orano Med Collaborate On Next-Generation Radioligand Medicine For Rare Cancers

Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi SA&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Phase 3 LIBERTY-CUPID Study C of Dupixent (dupilumab) <a href="https://www.benzinga.com/pressreleases/24/09/g40807674/dupixent-dupilumab-phase-3-trial-confirms-significant-improvements-in-itch-and-hives-for-patients-">was successful</a>. 
The study met the primary and key secondary endpoints for uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.
CSU is a chronic skin condition that causes hives and persistent itch. The positive trial confirms <a href="https://www.globenewswire.com/Tracker?data=oJfzeZikg10RZeSxzO67FTJgqO763K5kNdrm3HdSiqcD40rtdT3jzNA6fNFwjx6Nc4nhzD2dSQSvLQl3HyV4gYDP3X_suaBGqveOhY9q9Eer6rQOCE73MRR2wMX6cgXvQSFj_5ZktjzZKetwTtPHX37P_7ZxvG1ZhUGAYdI00TOJBZTY_y71Tyf7nSjtOpkcgqOj0D40hUijMplzH4mPEQ==" target="_blank" rel="noreferrer noopener">results</a> from Study A, the first Phase 3 trial of Dupixent in this setting.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40109548/regeneron-pharmaceuticals-q2-earnings-exceed-estimates-driven-by-its-top-selling-eczema-and-eye-d" rel="noreferrer noopener">Regeneron Pharmaceuticals&#8217; Q2 Earnings Exceed Estimates, Driven By Its Top-Selling Eczema And Eye Drugs</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 from Study A.
At 24 weeks, efficacy among patients receiving Dupixent compared to placebo was as follows:
<ul>
<li>8.64-point reduction in itch severity from baseline with Dupixent versus a 6.10-point reduction with placebo.</li>
<li>Dupixent reduced the severity of urticaria activity (itch and hive) by 15.86 points from baseline compared to 11.21 points with placebo.</li>
<li>30% of Dupixent-treated patients reported no urticaria (complete response) compared to 18% of placebo patients.</li>
</ul>
Detailed results from this trial will be provided to the FDA by year-end 2024 in response to the&nbsp;additional data requested&nbsp;for inclusion in the supplemental biologics license application for Dupixent in CSU after <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2023/2023-10-20-21-00-00-2764252" rel="noreferrer noopener">rejection</a> in October 2023.
Concurrently, Regeneron Pharmaceuticals and Sanofi announced that a Dupixent&nbsp;(dupilumab) ADEPT Phase 2/3 trial in bullous pemphigoid met the primary and all <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40807652/dupixent-dupilumab-is-the-first-and-only-biologic-to-achieve-significant-improvements-in-disease-r" rel="noreferrer noopener">key secondary endpoints</a>.
Five times more Dupixent patients achieved sustained disease remission in the trial than placebo patients.
For the primary endpoint, 20% of Dupixent patients experienced sustained disease remission at 36 weeks compared to 4% for placebo (p=0.0114).
Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 without relapse and no rescue therapy use during the 36-week treatment period.
For the components comprising the primary endpoint – with patients having to achieve all components – efficacy among patients receiving Dupixent compared to placebo was as follows:
<ul>
<li>The absence of disease relapse after the patient completed the OCS taper was 59% vs. 16%.</li>
<li>Absence of need for rescue therapy during the treatment period: 42% vs. 12%.</li>
<li>Achievement of complete remission and off OCS by week 16: 38% vs. 27% (not significant).</li>
</ul>
Additionally, a small separate Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin did not achieve statistical significance in its primary itch responder endpoint but showed nominally significant improvements in all other itch endpoints.
The Dupixent Phase 3 program in CPUO consists of Study A and Study B. Study B is planned to initiate as a subsequent pivotal trial.
Price Action: REGN stock closed at $1,136.35, and SNY stock closed at $58.08 on Tuesday.
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<ul>
<li>Confirming the results of Study A, this second pivotal trial in biologic-na&iuml;ve patients&nbsp;met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly&nbsp;50%&nbsp;reduction in itch and urticaria activity scores compared to placebo 
	&nbsp;</li>
<li>More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines</li>
<li>Data will support regulatory resubmission in the U.S. by year-end; if approved, Dupixent would be the first targeted therapy for CSU in a decade</li>
</ul>

Regeneron And Sanofi's Dupixent (Dupilumab) Phase 3 Trial Shows Significant Reductions In Itch And Hives For Chronic Spontaneous Urticaria (CSU) Patients

<ul>
<li>Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with Dupixent than placebo</li>
<li>Dupixent is the first medicine to show significant steroid-sparing effect in this debilitating and life-threatening disease</li>
<li>If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S. and European Union</li>
</ul>

Regeneron And Sanofi's Dupixent Becomes First Biologic To Achieve Significant Improvements In Disease Remission In Bullous Pemphigoid Trial

The results were presented today, in collaboration with Regeneron, for the first time at the 2024 European Respiratory Society (ERS) International Congress.

Pooled Analysis From Sanofi's BOREAS And NOTUS Phase 3 Studies Showed That Dupixent Reduced Exacerbations And Improved Lung Function Vs. Placebo For Uncontrolled Chronic Obstructive Pulmonary Disease And Evidence Of Type 2 Inflammation

WIIM

Sanofi shares are trading lower after Vir Biotechnology announced the closing of an exclusive license agreement with the company.

– License of proprietary masking platform further strengthens Vir's drug discovery capabilities in oncology and infectious disease –
– Strategic agreement expands Vir portfolio with three clinical stage assets in areas of high unmet need –
Vir Biotechnology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VIR#NASDAQ">VIR</a>) today announced that the exclusive worldwide license agreement with Sanofi announced on August 1, 2024, has closed following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The agreement provides Vir with an exclusive worldwide license to three clinical-stage masked T-cell engagers (TCEs) with potential applications in a range of cancers and exclusive use of the proprietary PRO-XTENTM masking platform for oncology and infectious disease. Key employees from Sanofi with extensive scientific and development expertise in TCEs, and in-depth experience using the PRO-XTEN platform, will join Vir. Further information about the TCEs and their respective development plans will be provided at Vir's upcoming R&amp;D Day in November.

Vir Biotechnology Announces Closing Of Exclusive Worldwide License Agreement With Sanofi For Multiple Potential Best-In-Class Clinical-Stage T-Cell Engagers; Strategic Agreement Expands Vir Portfolio With Three Clinical Stage Assets In Areas Of High Unmet Need

GSK&#39;s (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gsk#NYSE">GSK</a>) phase III study evaluating its blockbuster drug Nucala (mepolizumab), an anti-IL5 biologic, for treating chronic obstructive pulmonary disease (COPD), met its primary endpoint.
Data from the MATINEE study showed that in patients treated for up to 2 years, the addition of&nbsp;Nucala&nbsp;to inhaled maintenance therapy led to a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo, thereby meeting the study&#39;s primary endpoint.
COPD is a respiratory condition that affects more than 300 million people worldwide. Around 40% of COPD patients exhibit type II inflammation, which is associated with an increased risk of exacerbations, which are episodes of worsening respiratory symptoms. IL-5 is a core cytokine in type II inflammation. It promotes the growth and activation of eosinophils, a type of white blood cell involved in the inflammatory response.
GSK stock has risen 17.8% so far this year against a decrease of 2.8% for the industry.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/79/76939.jpg?v=1280252914" style="height:315px; width:600px" />
Image Source: Zacks Investment Research
<h2>More on GSK&#39;s Nucala Sales</h2>
Nucala is already approved in several countries for treating eosinophil-driven diseases like severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.
Sales of Nucala were up 15% at CER in the first half of 2024 to &pound;856, driven by strong patient demand globally.
<h2>Other Players in the Respiratory Diseases Market</h2>
Regeneron (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) and Sanofi&#39;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) blockbuster medicine, Dupixent, an IL-4 and IL-13 inhibitor, was approved for treating COPD in patients with raised blood eosinophils in the EU in July. The European Medicines Agency was the first regulatory authority in the world to approve Sanofi/Regeneron&#39;s Dupixent for COPD patients.
In the United States, a supplemental biologics license application (sBLA) seeking approval of Dupixent for COPD is under review with the FDA. The FDA&#39;s decision is expected on Sept. 27. Dupixent is currently approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
In addition to Dupixent, Nucala faces strong competition from AstraZeneca&#39;s Fasenra, also an IL-5 inhibitor like Nucala. Fasenra is approved for treating severe eosinophilic asthma. AstraZeneca is studying Fasenra in late-stage studies for COPD.
<h2>GSK&#39;s Zacks Rank</h2>
GSK has a Zacks Rank #3 (Hold).
<div class="chart_embed">
<h3>GSK PLC Sponsored ADR Price and Consensus</h3>
<img alt="GSK PLC Sponsored ADR Price and Consensus" src="https://staticx-tuner.zacks.com/images/charts/02/1725878658.png" style="height:265px; width:577px" title="" />
GSK PLC Sponsored ADR price-consensus-chart | GSK PLC Sponsored ADR Quote
<a href="https://www.zacks.com/stock/news/2333451/gsk-s-respiratory-drug-nucala-meets-goal-in-copd-study?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2333451">To read this article on Zacks.com click here.</a>
</div>

GSK's Respiratory Drug Nucala Meets Goal in COPD Study

Federal regulators are grappling with a significant backlog of factory inspections for drug manufacturing, with many facilities not reviewed since before the pandemic.
An analysis by The Associated Press of FDA data revealed that approximately 42% of the 4,700 registered plants have not undergone FDA surveillance inspections since 2019.
These facilities produce crucial medicines such as antibiotics, blood thinners, and cancer therapies, raising concerns over potential contamination and quality issues.
An AP analysis reveals that approximately 2,000 pharmaceutical manufacturers have not undergone FDA surveillance inspections since before the pandemic. This oversight raises potential contamination risks and other safety issues in medications.
A scholar from Duke University expressed concerns about generic drugmakers reducing costs at the expense of quality, which remains unchecked without proper inspections in an ABC News report.
Tainted medications, like the 2022 incident involving antibiotic-resistant bacteria in eyedrops from an Indian factory, underscore the risks of insufficient oversight.
These factories, particularly in India and China, are critical suppliers of low-cost prescription ingredients in the U.S.
Despite the challenges, FDA Associate Commissioner Michael Rogers <a target="_blank" href="https://abcnews.go.com/Health/wireStory/2000-drug-manufacturing-plants-overdue-fda-inspections-after-113414456" rel="noreferrer noopener">asserted</a> that the FDA is the world&#8217;s most stringent drug regulator. However, he acknowledged that inspection rates are still nearly 40% lower than pre-COVID levels, with no set timeline for clearing the backlog.
The situation is exacerbated by staffing challenges, with many experienced inspectors leaving for more flexible job opportunities.
Internationally, the FDA has been using video and online tools for preliminary assessments, but these do not substitute for physical inspections.
The Government Accountability Office has consistently marked this area as high-risk, signaling that more proactive measures are necessary. In the meantime, the FDA focuses on a risk-based approach to prioritize inspections that pose the greatest public health risk.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Photo via Shutterstock

Government

Regulations

BMRN

UTHR

FDA Battles Backlog of Drug Factory Inspections Since COVID-19

ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALXO#NASDAQ">ALXO</a>), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, announced the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study partnered with&nbsp;Sanofi&nbsp;that is evaluating evorpacept in combination with SARCLISA&#xAE; (isatuximab-irfc). Evorpacept is ALX Oncology's investigational CD47-blocking therapeutic that uniquely combines a high-affinity CD47-binding domain with an inactivated Fc domain and SARCLISA is&nbsp;Sanofi's approved CD38 monoclonal antibody in patients with relapsed or refractory multiple myeloma (RRMM). &nbsp;
SARCLISA binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. CD38 is highly and uniformly expressed on the surface of MM cells and after first-line treatment, some relapsed or recurred patients have shown resistance to CD38 agents. CD47 expression increases as multiple myeloma progresses, suggesting that evorpacept may have the potential to re-sensitize tumors to CD38 treatment or overcome anti-CD38 resistance. This novel therapeutic combination has demonstrated synergistic anti-tumor activity in preclinical models.

ALXO

ALX Oncology Announces First Patients Dosed With Evorpacept And Sarclisa As Part Of Randomized Phase 1/2 UMBRELLA Study With Sanofi

Sunday, Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) data from the HERCULES phase 3 study showed that tolebrutinib met the primary endpoint of improvement over placebo in delaying time to onset of confirmed disability progression (CDP) in non-relapsing secondary progressive <a target="_blank" href="https://www.benzinga.com/quote/sny" rel="noreferrer noopener">multiple sclerosis (nrSPMS)</a>.
In the HERCULES study, nrSPMS was <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-02-05-00-00-2938875" rel="noreferrer noopener">defined</a> at baseline as having an SPMS diagnosis with an expanded disability status scale (EDSS) score between 3.0 and 6.5, no clinical relapses for the previous 24 months, and documented evidence of disability accumulation in the previous 12 months.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40260365/sanofis-approved-blood-cancer-drug-sarclisa-shows-improved-progression-free-survival-in-patients-" rel="noreferrer noopener">Sanofi&#8217;s Approved Blood Cancer Drug Sarclisa Shows Improved Progression-Free Survival In Patients Eligible For Transplant</a>.
Preliminary analysis of liver safety was consistent with previous tolebrutinib studies.
The company also released results from the GEMINI 1 and 2 phase 3 studies of tolebrutinib that did not meet the primary endpoint of reducing annualized relapse rate (ARR), compared to teriflunomide, in relapsing forms of multiple sclerosis.
However, analysis of the key secondary endpoint of pooled 6-month confirmed disability worsening (CDW) data showed a considerable delay in time to onset, which supports the CDP data observed in HERCULES.
The PERSEUS phase 3 study in primary progressive multiple sclerosis, evaluating the time to onset of CDP, is currently ongoing, with study results anticipated in 2025.
&#8220;Tolebrutinib represents an unprecedented breakthrough as a potential first-in-disease treatment option with clinically meaningful benefit in disability accumulation,&#8221; said Houman Ashrafian, Sanofi&#8217;s head of research &amp; development.
In 2022, the&nbsp;FDA placed&nbsp;Sanofi&#8217;s Phase 3 studies of tolebrutinib in multiple sclerosis and myasthenia gravis <a target="_blank" href="https://www.benzinga.com/general/biotech/22/06/27913912/why-sanofi-shares-are-falling-today" rel="noreferrer noopener">on partial clinical hold</a>.&nbsp;
The FDA action was based on a limited number of drug-induced liver injury cases identified with tolebrutinib exposure in Phase 3 studies.&nbsp;
&#8220;Despite mixed news, tolebrutinib now appears a largely de-risked perhaps $1 billion-$2 billion opportunity,&#8221; Reuters noted, citing Jefferies analysts.
Reuters adds that investors remain cautious due to concerns about potential liver damage and questions surrounding the drug&#8217;s effectiveness, which cast uncertainty over its revenue prospects.
Price Action: SNY stock is up 2.84% at $57.86 during the premarket session at last check Tuesday.
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Image by HJBC via Shutterstock

Movers

Sanofi Still Bets On Multiple Sclerosis Med Tolebrutinib Despite The Investigational Drug Fell Short In 2 Of 3 Phase 3 Trials

Monday, Sanofi Said Results From GEMINI 1 And 2 Phase 3 Studies Of Tolebrutinib Did Not Meet The Primary Endpoint Of Reducing Annualized Relapse Rate, Compared To Teriflunomide, In Relapsing Forms Of Multiple Sclerosis

Monday, Sanofi's HERCULES Phase 3 Study Of Tolebrutinib Met The Primary Endpoint Of Improvement Over Placebo In Delaying Time To Onset Of Confirmed Disability Progression In Non-relapsing Secondary Progressive Multiple Sclerosis Patients

Global markets started September cautiously, with thin trading volumes as U.S. stock markets were closed for <a href="https://www.benzinga.com/markets/equities/24/09/40674353/is-the-market-open-on-labor-day">the Labor Day holiday</a>.
European markets closed the session marginally in the green, as traders anticipate imminent interest rate cut by the European Central Bank, The pan-European Euro Stoxx 50 index gained 0.3% for the day, closing at its highest level since mid-July. In Germany, the DAX index edged up 0.1%, setting a new record for its closing price.
Among large-cap European stocks, Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) led the gains with a 3.6% rise, followed by Orange (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ORAN#NYSE">ORAN</a>) and Telefonica SA (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEF#NYSE">TEF</a>), which climbed 1.7% and 1.5%, respectively.
The biggest laggards were Airbus SE (OTCPK: EADSY) , which fell 1.4%, Adidas AG (OTCPK: ADDY), down 0.9%, and both Kering SA (OTCPK: PPRUY) and BMW AG (OTCPK: BMWYY), each slipping 0.8%.
<h3 class="wp-block-heading">Other Markets</h3>
In the currency market, the euro rose 0.2% to 1.1070 against the dollar as of 2:00 p.m. ET: , snapping three straight sessions of declines. The British pound inched 0.1% against the greenback, while the Australian dollar rose 0.4%. 
The Japanese yen was the weakest performer on Monday, dropping 0.4% against the dollar, extending the trend from last week amid a reduction expectations for an aggressive Federal Reserve rate cut. 
In commodities markets, U.S. natural gas futures surged 2.8% to $2.10 per Million British Thermal Units, spurred by heightened demand for cooling. The Midwest region faced record-breaking temperatures over the weekend, prompting intense heat warnings for more than 60 million residents and driving up air conditioner usage.
Crude oil futures rose 0.5%, while gold eased 0.2% with the yellow metal falling slightly below $2,498.91. 
Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) rose over 2% to 58,550, after dropping 2.8% on Sunday. 
<h3 class="wp-block-heading">Monday&#8217;s Major Company News</h3>
<ul>
<li>The German automaker BMW is recalling its electric Mini Cooper SE vehicles due to battery issues that could potentially impact over 140,000 cars globally, according to Reuters.</li>
<li>In a note released on Monday by the European Medicines Agency (EMA), Dutch pharmaceutical company Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NOVO#NYSE">NOVO</a>) advised healthcare professionals to continue restricting the initiation of new patients until the supply situation stabilizes. Shares of Novo Nordisk fell 1%.</li>
<li>Private equity giant Blackstone Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BX#NYSE">BX</a>) has reached an agreement to acquire an 80% stake in a European warehouse portfolio managed by landlord Burstone Resources Inc. (OTCPK: BBSRF). </li>
</ul>
Read also: 
<ul>
<li><a href="https://www.benzinga.com/24/09/40676774/september-market-seasonality-why-this-month-is-historically-the-toughest-for-investors">September Market Seasonality: Why This Month Is Historically The Toughest For Investors</a></li>
</ul>

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Regeneron Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) announced that the European Commission&nbsp;approved odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma&nbsp;or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
The drug has been approved under the brand name Ordspono.
The approval is based on results from the phase I ELM-1 and pivotal phase II ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL.
Regeneron&#39;s shares have rallied 37.3% year to date against the industry&#39;s decline of 0.2%.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/f5/75596.jpg?v=1262470421" />
Image Source: Zacks Investment Research
<h3>Positive Study Results Help REGN</h3>
Results from ELM-2 (n=128), as assessed by an independent review committee, showed an objective response rate (ORR) of 80%, with 73% achieving a complete response&nbsp;in R/R FL.
Results from ELM-2 (n=127) in patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR in R/R DLBLCL.
Results from ELM-1 (n=60) in patients who had progressed after CAR-T therapy, as assessed by an IRC, showed 48% ORR, with 32% achieving a CR.
The approval in the EU is the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell.
Approval in the EU was mostly expected as the European Medicines Agency&#39;s Committee for Medicinal Products for Human Use recommended approval of odronextamab.
The EMA previously granted odronextamab Orphan Designation for FL and DLBCL.
<h3>REGN Suffers Setback With Odronextamab</h3>
Earlier, the company&#39;s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued complete response letters (CRLs) for its BLA for odronextamab in March 2024. The BLA is seeking the approval of the candidate R/R FL and R/R DLBCL.
The sole issue with the approval is related to the enrollment status of the confirmatory trials.
The CRLs (one for R/R FL and one for R/R DLBCL) did not identify any issue with the clinical efficacy or safety, trial design, labeling or manufacturing.
<h3>How Will the Approval Help Regeneron?</h3>
The successful development of these oncology drugs should be a great boost for REGN. It will also reduce its dependence on sales of lead ophthalmology drug Eylea and profits from asthma drug Dupixent for growth.
The firm is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
The company is investigating the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the phase III OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs and early-stage trials with chemotherapy-free combinations.
A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo for perioperative non-small cell lung cancer, was also initiated. A phase II/III study for fianlimab, in combination with Libtayo for perioperative melanoma, was also initiated.
<h3>Regulatory Setbacks Derail REGN</h3>
Last week, REGN received a CRL from the FDA for its BLA for pipeline candidate linvoseltamab.
The BLA is seeking FDA approval for linvoseltamab to treat R/R multiple myeloma that has progressed after at least three prior therapies.
Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company&#39;s product candidate.&nbsp;The CRL delays the potential approval of the candidate.
REGN has a collaboration agreement with Bayer (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>) for Eylea. The company records net product sales of Eylea and Eylea HD in the United States and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with sales of Eylea outside the United States.
Regeneron has a collaboration agreement with Sanofi (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) for Dupixent. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
<h3>Zacks Rank</h3>
Regeneron currently carries a Zacks Rank #3 (Hold).
<a href="https://www.zacks.com/stock/news/2327848/regeneron-s-bispecific-antibody-obtains-ec-nod-for-lymphoma?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2327848">To read this article on Zacks.com click here.</a>

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