Ultime notizie per GSK (NYSE:GSK) Azioni

In the pharmaceutical industry, GSK ranks as one of the largest firms by total sales. The company wields its might across several therapeutic classes, including respiratory, cancer, and antiviral, as well as vaccines. GSK uses joint ventures to gain additional scale in certain markets like HIV.

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Scopri i migliori titoli a dividendo del settore sanitario: analisi delle opportunità di investimento in Pfizer, GSK e CVS.

Titoli a dividendo: le migliori opportunità del settore sanitario

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

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The U.S. government has granted $72 million to European pharma giants GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and Australian firm CSL Limited (OTC:<a class="ticker" href="https://www.benzinga.com/stock/CSLLY#OTC">CSLLY</a>) to more than double the U.S. supply of <a target="_blank" href="https://www.benzinga.com/general/24/05/39029171/after-91-million-birds-infected-with-bird-flu-in-3-years-new-findings-on-cows-raise-concerns-70-work" rel="noreferrer noopener">bird flu vaccines</a>.
According to the&nbsp;Centers for Disease Control and Prevention, bird flu was detected in 254 dairy herds across 14 states.
Including the most recent two cases in California, 16 human cases of H5 have been <a target="_blank" href="https://www.cdc.gov/media/releases/2024/s1003-birdflu-case-california.html" rel="noreferrer noopener">reported</a> in the United States during 2024, bringing the total to 17 cases since 2022.
As part of the agreement, GSK, Sanofi, and CSL will produce extra bulk vaccine components tailored to the circulating strains of avian influenza.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41166018/medicare-drug-price-negotiation-program-gets-final-guidance-for-second-cycle-1-5b-savings-expecte" rel="noreferrer noopener">Medicare Drug Price Negotiation Program Gets Final Guidance For Second Cycle, $1.5B Savings Expected</a>.
In an interview with Bloomberg, Dawn O'Connell, the assistant secretary for preparedness and response at the Department of Health and Human Services, noted that the companies plan to allocate the funds to fill vials and pre-filled syringes with stored vaccine components. The goal is to increase the nation's total supply of ready-to-administer doses to 10 million by the first quarter of 2025.
According to O'Connell, the virus responsible for the ongoing outbreak has not changed in a manner that would compromise the effectiveness of the vaccines stored in stockpiles.
Additionally, some traditional flu vaccines are produced using eggs. Sanofi will ensure a steady supply of these vaccines to the United States to prepare for potential bird flu outbreaks and other needs.
The Bloomberg <a target="_blank" href="https://www.bloomberg.com/news/articles/2024-10-04/bird-flu-vaccine-sanofi-gsk-csl-get-us-funds-to-boost-supply" rel="noreferrer noopener">report</a> added that Finland is the sole nation vaccinating its population against bird flu.
Richard Webby, a bird flu researcher at St. Jude Children's Research Hospital in Memphis, noted that similar actions may be contemplated elsewhere if genetic mutations in the H5 viruses are in circulation. However, he emphasized that "it's a bit early to initiate any type of mass vaccination at this point."
The latest award from the&nbsp;Administration for Strategic Preparedness and Response of $72 million includes $37.9 million for CSL, $23.4 million for Sanofi, and $10.5 million for GSK.
Read Next:
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<li><a href="https://www.benzinga.com/general/biotech/24/10/41186615/sanofi-sells-global-rights-to-rare-autoimmume-drug-enjaymo-for-825m-upfront-to-italian-firm-recor" target="_blank" rel="noreferrer noopener">Sanofi Sells Global Rights To Rare Autoimmune Drug Enjaymo For $825M Upfront To Italian Firm Recordati</a></li>
</ul>
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Biotech

Government

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Health Care

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CSLLY

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

Contracts

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

On Wednesday, the U.S. Department of Health and Human Services (HHS), working via the Centers for Medicare &amp; Medicaid Services (CMS), released final guidance for the second cycle of the <a href="https://www.benzinga.com/general/health-care">Medicare Drug Price Negotiation Program</a>.
This initiative <a target="_blank" href="https://www.cms.gov/newsroom/press-releases/hhs-releases-final-guidance-second-cycle-historic-medicare-drug-price-negotiation-program" rel="noreferrer noopener">aims</a> to provide lower drug prices starting in 2026 and 2027.
It also ensures that people with Medicare can access these negotiated prices, expanding on the groundwork laid in the first cycle of negotiations.
The first round of negotiations focused on 10 specific drugs. Medicare recipients should save approximately $1.5 billion in out-of-pocket costs when the new prices take effect in 2026.
By February 2025, CMS will select up to 15 additional drugs for the second round of negotiations. The selected drugs will undergo negotiations in 2025, with new prices becoming effective in 2027.
They include: 
<ul>
<li>Novo Nordisk&#8216;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) diabetes drug, <a href="https://www.benzinga.com/general/biotech/24/08/40534249/novo-nordisks-ozempic-might-be-among-2027-medicare-price-negotiation-targets">Ozempic,</a></li>
<li>Pfizer Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) cancer drugs Ibrance and Xtandi</li>
<li>GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) asthma treatment Trelegy Ellipta</li>
<li>Teva Pharmaceutical Industries Ltd.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) Huntington&#8217;s disease drug Austedo, and</li>
<li>Abbvie Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) irritable bowel syndrome treatment Linzess.</li>
</ul>
CMS plans to improve patient-focused engagement during the second cycle of negotiations. It will also organize roundtable events and town hall meetings in 2025.
As Medicare Open Enrollment approaches on Oct. 15, beneficiaries can expect more cost-saving measures in the coming years. That includes a $2,000 annual cap on out-of-pocket drug costs starting in January 2025.
These changes build on other provisions of the Inflation Reduction Act, which was signed by President Joe Biden on Aug. 16, 2022. The legislation included a $35 monthly cap on insulin and free recommended vaccines for adults covered under Medicare Part D.
Monday, the U.S. Department of Health and Human Services (HHS) announced that Medicare enrollees will benefit from reduced prices on 54 drugs through Medicare Part B, effective from Oct. 1, 2024, to Dec. 31, 2024. Some Medicare beneficiaries could see daily savings ranging from $1 to as much as $3,854 on drugs included <a href="https://www.benzinga.com/general/biotech/24/10/41127143/us-hhs-reveal-cost-savings-for-54-prescription-drugs-including-novartis-cancer-drug-ozempic-could" target="_blank" rel="noreferrer noopener">in the rebate program</a>.
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</ul>
Image: Shutterstock

ABBV

TEVA

Medicare Drug Price Negotiation Program Gets Final Guidance For Second Cycle, $1.5B Savings Expected

Global

NVAX

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

Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) has divested a $3.3 billion stake in Haleon (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HLN#NYSE">HLN</a>), reducing its holding in the British consumer healthcare company.
What Happened: The transaction occurred on Monday, cutting Pfizer&#8217;s shareholding from 22.6% to 15%. The shares were sold at 380 pence each, a 3.3% discount to Haleon&#8217;s last closing price.
Haleon, known for products like Sensodyne toothpaste and Panadol painkillers, saw its shares drop 1.2% to 388 pence in Tuesday morning trade. Despite the sale, Pfizer remains Haleon&#8217;s largest shareholder.
The U.S. drug giant had initially planned to sell about 540 million shares but increased this to 640 million due to strong demand, a book-runner on the deal stated. Haleon confirmed it will repurchase approximately 60.5 million of its shares from Pfizer for 230 million pounds ($307.4 million).
See Also: <a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41066762/if-you-invested-1000-in-bitcoin-dogecoin-and-shiba-inu-exactly-a-year-ago-this-crypto-woul?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">If You Invested $1000 In Bitcoin, Dogecoin, And Shiba Inu Exactly A Year Ago, This Crypto Would Give You The Best Returns Today</a>
Why It Matters: This divestment comes on the heels of Pfizer&#8217;s recent challenges. 
On Thursday, Pfizer announced the voluntary withdrawal of its sickle cell disease treatment Oxbryta (voxelotor) <a href="https://www.benzinga.com/general/biotech/24/09/41048780/pfizer-voluntarily-withdraws-sickle-cell-disease-treatment-oxbryta-from-global-market-due-to-pain">from the global market</a> due to severe complications and deaths. This decision also included halting all active clinical trials and expanding access programs for the drug.
Price Action: Pfizer Inc. stock closed at $28.94 on Monday, down 0.52% for the day, and is currently trading at $29.01 in pre-market, reflecting a slight gain of 0.24%. Year-to-date, Pfizer&#8217;s stock has declined by 2.66%.
Meanwhile, Haleon PLC &#8211; ADR finished at $10.58, down 0.84% on the same day, with a pre-market price up by 0.19%. The stock has performed well this year, rising by 28.55%, according to <a href="https://www.benzinga.com/pro/">data from Benzinga Pro</a>.
Read Next: 
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<li><a href="https://www.benzinga.com/markets/equities/24/09/41084992/nvidia-stock-could-touch-800-by-2030-bgg-executive-predicts-550-upside-driven-by-ai-revolution-a?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Nvidia Stock Could Touch $800 By 2030, BGG Executive Predicts 550% Upside Driven By AI Revolution And Web3 Transition</a></li>
</ul>
Image Via Shutterstock 
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Equities

Pfizer Divests $3.3B Stake In Sensodyne Toothpaste And Panadol Painkiller Maker Haleon

Macro Economic Events

Economics

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

The Federal Reserve rate cuts have sent the market up, but some stocks are rising more than others. That includes small pharmaceutical companies like Wave Life Sciences (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/wve#NASDAQ">WVE</a>), whose shares rose 9% the day after the central bank reduced rates by 50 basis points.
However, rate cuts are not the only reason for excitement around the company. The average of recent Wall Street analyst price targets signals an 85% upside potential in the stock. I&#39;ll analyze the progress Wave Life Sciences has made in its treatment, its financial situation, and what to watch for next.
<h2>Wave May Have an &quot;Industry-Leading&quot; DMD Treatment</h2>
Wave currently has four drugs in development, but I&#39;ll focus on WVE-N531. This drug aims to treat Duchenne Muscular Dystrophy (DMD), a condition that mostly affects young boys. The drug is currently in Phase 2 Food and Drug Administration (FDA) trials.
DMD is characterized by low levels of dystrophin production. One of the main ways to increase dystrophin production is through &quot;exon skipping.&quot; These drugs help the body skip over malfunctioning parts of the genetic code (exons) that cause low dystrophin levels. By skipping over these exons, the body should produce more dystrophin. Wave&#39;s drug specifically aims to skip over exon 53.
In the company&#39;s preclinical trials, the drug achieved exon skipping levels of 53%. The firm says this percentage is &quot;industry-leading.&quot; Although the company does not cite how much dystrophin production increased, exon skipping correlates with it. So, it is possible that dystrophin production could be industry-leading as well.
From a business perspective, one issue with this treatment is that the market is very small. Different people are affected by different exons malfunctioning. Since WVE-N531 is being researched specifically to skip exon 53, it is currently only aimed at treating 8% to 10% of DMD patients. In the United States and Europe, that is only around 2,300 people. Still, this could result in significant revenue.
According to the firm, exon-skipping treatments brought in $1 billion industry-wide in 2023. Those affected by exon 53 make up around a quarter of the total when looking at the five largest exon patient groups. So, it&#39;s conceivable that there may be a current market of around $250 million for the drug. The DMD market is expected to continue growing considerably; however, estimates are wide-ranging, from 10% to 39% per year.
<h2>Wave&#39;s Financials Show Positives and Negatives</h2>
Over the past several years, Wave Life Sciences hasn&#39;t been a good investment at all. The stock has provided a cumulative total return of just 5% in three years. As with many small firms in the pharma industry, Wave currently has no approved medications. However, the company has been able to generate some significant revenue.
Wave has generated at least $12 million in revenue in each of the last six quarters. This revenue mainly comes from &quot;collaborations&quot; with large pharmaceutical companies.&nbsp;Takeda (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/tak#NYSE">TAK</a>)&nbsp;and&nbsp;GSK (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gsk#NYSE">GSK</a>) have collaborated with Wave. Although Wave isn&#39;t generating&nbsp;much revenue, anything helps when the company is spending $30 million to $40 million a quarter on research and development.
The company currently has $154 million in cash and equivalents on its balance sheet. That may last a little over a year, considering the company has burned through $130 million in cash from operations over the last twelve months. It will need to issue more stock soon, which will dilute shareholders.
<h2>Good News Around WVE-N531 and What to Watch For</h2>
The company&nbsp;recently received good news regarding the drug. The FDA granted the drug the&nbsp;Rare Pediatric Disease Designation. This means that if the drug is approved, the company will receive a Priority Review Voucher (PRV). The PRV allows the company to speed up the review of a future drug by four months. However, PRVs can also be sold to other companies.
Recent data shows that PRVs are now selling for an average of $100 million. Thus, selling the PRV could bring in significant revenue if WVE-N531 is approved. Alternatively, it could use the PRV itself to speed up the review of its own future treatments.
I&#39;ll be watching Waves&#39; upcoming results for WVE-N531, which they plan to release in Q3. The results will include data on changes in dystrophin levels. Seeing the number come in above the 5.7% to 5.9% increase of the already approved treatment Viltepso could add significant validity to the Wave Life Sciences bull case.
The article &quot;<a href="https://www.marketbeat.com/stock-ideas/analysts-predict-85-upside-for-wave-life-sciences-after-rate-cut/">Analysts Predict 85% Upside for Wave Life Sciences After Rate Cut</a>&quot; first appeared on MarketBeat.

Small Cap

Federal Reserve

Analysts Predict 85% Upside for Wave Life Sciences After Rate Cut

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

Rumors

Media

KVUE

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

In July 2021, Alector Entered Into A Collaboration With GSK For Global Development And Commercialization Of Progranulin-Elevating Monoclonal Antibodies, Receiving $700M Upfront And Eligible For Up To $1.5B In Milestone Payments; Companies Will Share U.S. Profits Equally, With Alector Receiving Double-Digit Royalties Internationally

ALEC

Alector Presents Baseline Data For INFRONT-3 Phase 3 Trial Of Latozinemab At ISFTD 2024, Targeting Frontotemporal Dementia With Progranulin Gene Mutation (FTD-GRN)

The FDA approved on Wednesday AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Fasenra&nbsp;(benralizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can result in damage to multiple organs.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-us-for-eosinophilic-granulomatosis-with-polyangiitis.html" rel="noreferrer noopener">approval</a> was based on data from the MANDARA Phase 3 trial published in&nbsp;The New England Journal of Medicine, which compared the efficacy and safety of&nbsp;Fasenra&nbsp;to the only approved EGPA treatment, GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Nucala (mepolizumab).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40793946/astrazeneca-ceo-pascal-soriot-updates-on-chinese-compliance-probe-and-lung-cancer-drug-trial-resu" rel="noreferrer noopener">AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results</a>
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.
In the trial, nearly 60% of&nbsp;Fasenra-treated patients achieved remission, comparable to mepolizumab-treated patients.
Data also showed 41% of&nbsp;Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm).
The safety and tolerability profile for&nbsp;Fasenra&nbsp;in the MANDARA trial was consistent with the known profile of the medicine.
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra&nbsp;is the second biologic approved to treat this disease.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries.
It is also approved in children and adolescents ages six and above in the U.S. and Japan.
Last month, the FDA approved&nbsp;AstraZeneca&#8217;s Imfinzi&nbsp;(durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39958623/astrazeneca-posts-mixed-q2-earnings-still-raises-annual-guidance-on-strong-demand-for-cancer-rare" rel="noreferrer noopener">lymphoma kinase rearrangements</a>.
AZN Price Action: AstraZeneca stock is down 0.16% at $78.41 at publication Wednesday.
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</ul>
Photo: Shutterstock

AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation

Wednesday, GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) released topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of Arexvy (Respiratory Syncytial Virus Vaccine) when co-administered with <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b40915839/gsk-announces-positive-topline-data-on-co-administration-of-arexvy-and-shingrix" rel="noreferrer noopener">Shingrix (Zoster Vaccine)</a>.
<ul>
<li>Shingrix is approved to prevent shingles (herpes zoster) in adults aged 50 and older.</li>
<li>Arexvy is approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older and in individuals 50 through 59 who are at increased risk for LRTD caused by RSV.</li>
</ul>
The data were presented as a late-breaking abstract at the European Geriatric Medicine Society (EuGMS) Congress.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40817991/gsk-halts-herpes-simplex-virus-vaccine-development-clears-path-for-other-contenders-like-moderna-" rel="noreferrer noopener">GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech</a>.
The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits.
Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles.
In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia.
The duration of solicited adverse events was comparable across the two groups.
Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the FDA, the European Medicines Agency, and other regulators.
Each year, approximately 177,000 adults 65 years and older are hospitalized in the US due to RSV, and an estimated 14,000 of those cases result in death.
Shingles is a painful, blistering rash caused by the reactivation of the varicella-zoster virus (VZV)—the same virus that causes chickenpox.&nbsp;An estimated one million people develop shingles annually in the US.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>).
Price Action: GSK stock is up 0.59% at $42.81 at the last check on Wednesday.
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</ul>

AGEN

GSK's Respiratory Syncytial Virus Vaccine Given Together With Shingles Shot Shows Non-Inferior Immune Response In Older Adults

<ul>
<li>Co-administration of the RSV and shingles adjuvanted vaccines was well tolerated, with acceptable reactogenicity and safety profiles</li>
<li>These data advance the science of co-administration of recommended adult vaccines</li>
</ul>

GSK's Phase 3 Trial In Adults 50 Years And Older Of Arexvy (Respiratory Syncytial Virus Vaccine) When Co-administered With Shingrix (Zoster Vaccine) Met Its Primary Endpoint

Japan's Ministry Of Health, Labour And Welfare Has Accepted For Review GSK's New Drug Application For Blenrep (Belantamab Mafodotin) In Combination With Bortezomib Plus Dexamethasone Or Pomalidomide Plus Dexamethasone For Relapsed Or Refractory Multiple Myeloma

<ul>
<li>Clinically meaningful objective response rate (ORR) of 63.3-76.7% observed with belrestotug + dostarlimab combinations, with confirmed ORR (cORR) at ~60% for every dose.</li>
<li>&gt;30% cORR difference between belrestotug + dostarlimab vs dostarlimab monotherapy.</li>
<li>Belrestotug + dostarlimab safety profile broadly consistent with known safety profile of checkpoint inhibitor combinations.</li>
<li>GALAXIES Lung-301, global Phase 3 registration study, enrolling in same indication and setting</li>
</ul>

ITOS

Reported Saturday, iTeos Therapeutics Announced Follow-Up Interim Data From GALAXIES Lung-201 Phase 2 Platform Study Sponsored By GSK, For Belrestotug+Dostarlimab Doublet In Previously Untreated, Unresectable, Locally Advanced Or Metastatic PD-L1 High Non-small Cell Lung Cancer

Thursday, GSK plc (LSE/NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) announced headline results of a phase 2 trial for its mRNA seasonal <a href="https://www.benzinga.com/topic/influenza">influenza vaccine program</a>.
The <a href="https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-headline-data-from-phase-ii-seasonal-influenza-mrna-vaccine-programme/" target="_blank" rel="noreferrer noopener">trial</a> studied a range of mRNA formulations in older and younger adults to evaluate vaccine candidates that could improve immune responses against influenza A and B strains, compared to the current standard of care.
The data demonstrated positive immune responses against influenza A and B strains compared to the current standard of care, meeting all predefined success criteria in the tested age groups of older and younger adults.
Also Read: <a href="https://www.benzinga.com/general/biotech/24/09/40817991/gsk-halts-herpes-simplex-virus-vaccine-development-clears-path-for-other-contenders-like-moderna-" target="_blank" rel="noreferrer noopener">GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech</a>.
Interim data suggest the vaccine candidates have an acceptable safety and reactogenicity profile for all mRNA formulations tested.
These results build on the previous phase 2 trial and confirm the mRNA platform elicits strong overall antibody titres with an acceptable safety profile.
With these results, the GSK mRNA seasonal influenza vaccine program will progress into late-stage clinical development.
Vaccine candidate based on CureVac N.V.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) proprietary second-generation mRNA backbone
The Phase 2 study was <a target="_blank" href="https://www.curevac.com/en/curevac-partner-gsk-announces-positive-phase-2-data-from-seasonal-influenza-mrna-vaccine-program/" rel="noreferrer noopener">initiated</a> following interim data reported in April from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza.
In July, GSK and&nbsp;CureVac restructured their existing collaboration into a new licensing agreement, allowing the companies to prioritize investment and focus on their respective mRNA <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39615546/gsk-buys-full-rights-to-investigational-covid-19-and-influenza-vaccines-from-curevac-for-around-1" rel="noreferrer noopener">development activities</a>.
Since 2020, GSK and CureVac have&nbsp;<a target="_blank" href="https://www.curevac.com/en/gsk-and-curevac-to-restructure-collaboration-into-new-licensing-agreement/" rel="noreferrer noopener">worked</a>&nbsp;together to develop mRNA vaccines for infectious diseases.
Price Action: GSK stock is down 0.91% at $43.37, and CVAC stock is down 1.98% at $2.97 at last check Thursday.
Read Next:
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<li><a href="https://www.benzinga.com/government/24/09/40834852/nvidia-ai-chips-headed-to-saudi-arabia-us-reassesses-export-ban" target="_blank" rel="noreferrer noopener">Nvidia AI Chips Headed to Saudi Arabia, US Reassesses Export Ban</a></li>
</ul>

CVAC

GSK Reveals 'Positive' Data From Mid-Stage Study Of Seasonal Influenza mRNA Vaccine

Earlier Today, GSK Announced Headline Results Of A Phase 2 Trial For Its mRNA Seasonal Influenza Vaccine Program, Demonstrating A And B Strain Immune Responses Relative To Standard Of Care In Both Younger And Older Adults

Legal

GSK Confirms It Has Reached A Confidential Settlement With Mr. Isaac Dixon, Resolving The Prostate Cancer Case Filed In Illinois State Court; GSK Does Not Admit Any Liability In This Settlement. The Case Will Now Be Dismissed.

GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) shelved on Wednesday its herpes simplex virus (HSV) vaccine development program.
The recombinant protein vaccine, dubbed GSK3943104, did not meet the study&#8217;s primary efficacy objective.
GSK <a href="https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-therapeutic-herpes-simplex-virus-hsv-vaccine-trial/" target="_blank" rel="noreferrer noopener">added</a> that the vaccine candidate will not progress to phase three studies.
No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up.
&#8220;Given the unmet medical need and burden associated with genital herpes, innovation in this area is still needed,&#8221; the company said. &#8220;GSK intends to evaluate the totality of all these data and other studies to progress future research and development of its HSV program.&#8221;
There are no approved vaccines for HSV, and GSK&#8217;s decision to stop developing GSK3943104 eliminates a key contender in the race to market.
Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) is <a href="https://investors.modernatx.com/news/news-details/2024/Moderna-Advances-Multiple-Vaccine-Programs-to-Late-Stage-Clinical-Trials/default.aspx" target="_blank" rel="noreferrer noopener">developing</a> mRNA-1608, an investigational vaccine for herpes simplex virus type 2. The candidate is currently in phase 1/2 trial that is fully enrolled with  300 participants in the U.S. Data is <a href="https://trials.modernatx.com/study/?id=mRNA-1608-P101" target="_blank" rel="noreferrer noopener">expected</a> in June 2025.
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) partner BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) is <a href="https://investors.biontech.de/news-releases/news-release-details/biontech-starts-phase-1-clinical-trial-prophylactic-herpes" target="_blank" rel="noreferrer noopener">developing</a> BNT163, a prophylactic vaccine candidate being studied in a phase one clinical trial.&nbsp;
The German company initiated the phase one trial in December 2022, with an estimated enrollment of 248 participants. Data is <a href="https://clinicaltrials.gov/study/NCT05432583" target="_blank" rel="noreferrer noopener">expected</a> in 2025.
There are an estimated four billion people globally infected with HSV.
GSK Price Action: GSK stock is down 1.12% at $43.61 at last check Wednesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/09/40816135/rocket-lab-usa-hires-rivian-veteran-frank-klein-as-new-coo-whats-going-on" target="_blank" rel="noreferrer noopener">Rocket Lab USA Hires Rivian Veteran Frank Klein As New COO &#8211; What&#8217;s Going On?</a></li>
</ul>

BNTX

MRNA

GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech

Earlier Today GSK's Phase 1/2 Proof-Of-Concept Study Of GSK3943104 Did Not Meet The Study's Primary Efficacy Objective, Hence It Will Not Progress To Phase 3 Studies

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>

REGN

GSK's Respiratory Drug Nucala Meets Goal in COPD Study

Here are the Medicare Part D drugs expected to face 2025 price negotiations

Barclays analyst Emily Field maintained a Hold rating on GlaxoSmithKline (GSK – Research Report) today and set a price target of £16.50. The compan...

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Pfizer cuts Haleon stake in $3.3B share sale

Pfizer Inc. ($PFE) has sold its stake worth $3.26 billion in UK-based consumer healthcare company Haleon PLC ($GB:HLN). With this transaction, Pfiz...

Pfizer Sells $3.26B Stake in Haleon

J.P. Morgan analyst James Gordon maintained a Sell rating on GlaxoSmithKline (GSK – Research Report) today and set a price target of £15.50. The co...

J.P. Morgan Reaffirms Their Sell Rating on GlaxoSmithKline (GSK)

In a report released today, Peter Welford from Jefferies maintained a Buy rating on GlaxoSmithKline (GSK – Research Report), with a price target of...

Jefferies Sticks to Its Buy Rating for GlaxoSmithKline (GSK)

Goldman Sachs analyst Rajan Sharma maintained a Hold rating on GlaxoSmithKline (GSK – Research Report) today and set a price target of £18.00. The ...

Goldman Sachs Sticks to Their Hold Rating for GlaxoSmithKline (GSK)

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

EU regulators reviewing safety of finasteride, dutasteride

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

ALPMF

ALPMY

AMGN

GILD

SNYNF

Press Releases

GSK and CureVac to Restructure Collaboration into New Licensing Agreement

GSK Begins Shipping Influenza Vaccine Doses for 2024-25 Season

GSK and Flagship Pioneering partner to discover novel medicines and vaccines

US FDA expands Jemperli (dostarlimab-gxly) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit

Lucrative Incentive for Biotechs as Global Alzheimer's Disease Therapeutics Market Forecasted to Reach $30.8 Billion By 2033

Earnings

Myriad Genetics Reports Strong Second Quarter 2024 Financial Results, including 15% Revenue Growth Year-Over-Year; Raises 2024 Financial Guidance and Long-Term Revenue Growth Target to 12%

Brooke Shields Partners with GSK to Educate Adults 50 and Older About Their Shingles Risk

GSK Announces Positive Topline Data on Co-Administration of AREXVY and SHINGRIX

Alector Presents Baseline Characteristics for Pivotal INFRONT-3 Phase 3 Clinical Trial at the 14th International Conference on Frontotemporal Dementias (ISFTD 2024)

Opinion

Beyond the Horizon: Innovative Drug Combinations Offer New Hope for Alzheimer's and More

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