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

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

Sanofi

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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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FTC files a complaint against CVS, Cigna, and UnitedHealth&#39;s PBMs, accusing them of inflating insulin prices through a rebate-driven system. The case aims to address unfair practices and improve access to affordable insulin.

US Federal Trade Commission Sues CVS Health, Cigna, UnitedHealth&#39;s Pharmacy Benefit Managers For Inflating Insulin Prices

Biotech

Sanofi reports positive phase 3 HERCULES study data for tolebrutinib in non-relapsing secondary progressive multiple sclerosis, showing a 31% delay in disability progression. Study also revealed increased disability improvement, while safety concerns included liver enzyme elevations.

Sanofi&#39;s Tolebrutinib Delays Disability Progression In Patients With Multiple Sclerosis, Data Shows

Novartis

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

Sanofi SA

Synthetify

SUNNYLIFE GLOBAL INC by Sunnylife Global, Inc.

Sunnylife Global Inc

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

On Friday, the Federal Trade Commission (FTC) filed a formal complaint against three major pharmacy benefit managers (PBMs)—CVS Health Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) Caremark, Cigna Corp&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>) Express Scripts, and UnitedHealth Group Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>) Optum—for allegedly engaging in unfair and anti-competitive practices that have inflated the list <a target="_blank" href="https://www.benzinga.com/government/24/07/39695378/ftc-investigation-uncovers-anti-competitive-practices-by-handful-of-pharmacy-benefit-managers-includ" rel="noreferrer noopener">price of insulin medications</a>.
The <a target="_blank" href="https://www.ftc.gov/news-events/news/press-releases/2024/09/ftc-sues-prescription-drug-middlemen-artificially-inflating-insulin-drug-prices" rel="noreferrer noopener">complaint</a> accuses the PBMs of creating a system that benefits them financially by prioritizing drug rebates, forcing patients to pay higher costs for life-saving insulin. These PBMs, referred to as the Big Three, administer around 80% of prescriptions in the U.S.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38564498/federal-trade-commission-targets-junk-patent-listings-for-diabetes-weight-loss-asthma-drugs-from-" rel="noreferrer noopener">Federal Trade Commission Targets &#8216;Junk Patent Listings&#8217; For Diabetes, Weight Loss, Asthma Drugs From Companies Like Novo Nordisk, AstraZeneca</a>.
The FTC claims that the PBMs abused their market power to inflate insulin prices by promoting a rebate system with drug manufacturers.
This system led to the exclusion of lower-priced insulin from formularies, further driving up the cost for vulnerable patients.
The result is higher out-of-pocket expenses for those needing essential diabetes medication.
For example, the list price of Eli Lilly And Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) Humalog rose dramatically from $21 in 1999 to over $274 in 2017.
Despite the availability of lower-priced alternatives, PBMs favored higher-priced drugs due to the lucrative rebates they provided.
The FTC is also examining the role of drug manufacturers, including Eli Lilly, 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>), in driving up insulin prices, signaling potential further action against these companies.
The rebate-driven system excluded lower-priced insulins and allowed the Big Three PBMs to keep significant revenue in the form of rebates and fees, a strategy that hurt patients while benefiting the PBMs financially.
Vulnerable patients, such as those with high deductibles or coinsurance, bore the brunt of these inflated costs, paying more for their insulin than the overall net cost to insurers.
Price Action: At last check Friday, CVS stock was down 1.61% at $57.49, UNH stock was down 0.29% at $575.39, and CI stock was up 0.07% at $357.52.
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Photo by towfiqu barbhuiya via unsplash

US Federal Trade Commission Sues CVS Health, Cigna, UnitedHealth's Pharmacy Benefit Managers For Inflating Insulin Prices

FTC Alleges Pharmacy Benefit Managers Systematically Excluded Cheaper Insulins In Exchange For Expensive, Highly Rebated Alternatives

FTC Sues Units Of CVS Health , Cigna , And UnitedHealth For Allegedly Artificially Inflating Insulin Prices; FTC Case Does Not Name Insulin Drugmakers Eli Lilly, Novo Nordisk, And Sanofi , But Agency Reserves Right To Sue Later

Friday, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) released data from the HERCULES phase 3 study of tolebrutinib for non-relapsing secondary progressive multiple sclerosis (nrSPMS).
The <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-20-09-30-00-2949552" rel="noreferrer noopener">data</a> demonstrated that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by 31% compared to placebo (HR 0.69; p=0.0026).
Further analysis of secondary endpoints demonstrated that the number of participants who experienced confirmed disability improvement increased by nearly two-fold, 10% with tolebrutinib compared to 5% with placebo (HR 1.88; nominal p=0.021).
Based on the preliminary analysis of the HERCULES study, there was a slight increase in tolebrutinib-treated patients of some adverse events.
Liver enzyme elevations were observed in 4.1% of participants receiving tolebrutinib compared with 1.6% in the placebo group, a side effect also reported with other BTK inhibitors in MS.
All but one case of liver enzyme elevations were resolved without further medical intervention.
Earlier this month, Sanofi 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 Aubagio (teriflunomide) in relapsing <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40684403/sanofi-still-bets-on-multiple-sclerosis-med-tolebrutinib-despite-the-investigational-drug-fell-sh" rel="noreferrer noopener">forms of multiple sclerosis</a>.
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.
In preliminary analysis of the GEMINI 1 and 2 pooled safety data, adverse events observed between the tolebrutinib and Aubagio arms were generally balanced. Liver enzyme elevations were observed in 5.6% of participants receiving tolebrutinib compared with 6.3% of participants receiving Aubagio.
Study results will form the basis for future discussions with global regulatory authorities, with submissions starting in H2 2024.
The PERSEUS phase 3 study in primary progressive MS is ongoing, with study results anticipated in H2 2025.
Price Action: SNY stock is down 0.53% at $57.95 during the premarket session at last check Friday.
Read Next:
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<li><a href="https://www.benzinga.com/general/biotech/24/09/40956171/european-drug-agency-supports-novo-nordisks-blockbuster-weight-loss-drug-wegovy-for-obesity-relat" target="_blank" rel="noreferrer noopener">European Drug Agency Supports Novo Nordisk&#8217;s Blockbuster Weight-Loss Drug Wegovy For Obesity-Related Heart Failure</a>.</li>
</ul>
Image by HJBC via Shutterstock

Sanofi's Tolebrutinib Delays Disability Progression In Patients With Multiple Sclerosis, Data Shows

REGN

The European Medicines Agency's Committee For Medicinal Products For Human Use Adopted A Positive Opinion Recommending The Expanded Approval Of Regeneron Pharmaceuticals/Sanofi's Dupixent (Dupilumab) For Eosinophilic Esophagitis In Children Down To 1 Year Of Age

Positive results from the HERCULES phase 3 study in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS) demonstrated that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by 31% compared to placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026). Further analysis of secondary endpoints demonstrated that the number of participants who experienced confirmed disability improvement increased by nearly two-fold, 10% with tolebrutinib compared to 5% with placebo (HR 1.88; 95% CI 1.10 to 3.21; nominal p=0.021). These results were presented today as a late-breaking presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 conference in Copenhagen, Denmark.

Sanofi Says Tolebrutinib Demonstrated 31% Delay In Time To Onset Of Confirmed Disability Progression In Non-relapsing Secondary Progressive Multiple Sclerosis Phase 3 Study; Global Regulatory Submissions Will Begin In H2 2024

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

<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>
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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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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.

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