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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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The FDA has approved AstraZeneca&#39;s Fasenra for eosinophilic granulomatosis with polyangiitis based on Phase 3 MANDARA trial results. The drug showed similar remission rates to GSK&#39;s Nucala.

AstraZeneca&#39;s Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation

AGEN

GSK released data from a Phase 3 trial evaluating the co-administration of Arexvy and Shingrix vaccines in adults 50+. The study showed a non-inferior immune response and good safety profiles. The results will support regulatory submissions to the FDA and EMA.

GSK&#39;s Respiratory Syncytial Virus Vaccine Given Together With Shingles Shot Shows Non-Inferior Immune Response In Older Adults

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CVAC

GSK announced positive phase 2 trial results for its mRNA seasonal flu vaccine, showing strong immune.

GSK Reveals &#39;Positive&#39; Data From Mid-Stage Study Of Seasonal Influenza mRNA Vaccine

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

GSK PLC

Goldseek Resources Inc Ordinary Shares

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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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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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.
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</ul>

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.
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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>

Markets

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REGN

GSK's Respiratory Drug Nucala Meets Goal in COPD Study

GSK Announces Depemokimab Late-Breaking Data Presented At ERS Show A 54% Reduction In Severe Asthma Exacerbations; SWIFT-1 And SWIFT-2 Phase III Data Show Depemokimab Delivered Significant And Clinically Meaningful Reduction In Exacerbations Over 52 Weeks Versus Placebo Plus Standard Of Care, In Duplicate Studies

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

Friday, GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) released the headline results of the MATINEE Phase 3 trial evaluating&nbsp;Nucala&nbsp;(mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive <a target="_blank" href="https://www.benzinga.com/quote/gsk" rel="noreferrer noopener">pulmonary disease (COPD)</a>, or smoker&#8217;s lungs.
The trial <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/gsk-announces-positive-results-from-phase-iii-trial-of-nucala-mepolizumab-in-copd/" rel="noreferrer noopener">recruited</a> COPD patients with broad clinical presentations of chronic bronchitis and/or emphysema who were receiving optimized inhaled maintenance therapy.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38924821/amgenastrazeneca-say-asthma-drug-shows-activity-in-another-lung-disease-across-broad-patient-popu" rel="noreferrer noopener">Amgen/AstraZeneca Say Asthma Drug Shows Activity In Another Lung Disease Across Broad Patient Population</a>.
Participants were also required to have evidence of type 2 inflammation characterized by raised blood eosinophil count.
MATINEE met its primary endpoint with the addition of&nbsp;Nucala&nbsp;to inhaled maintenance therapy, and study results showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.
The preliminary safety results are consistent with the known safety profile of&nbsp;Nucala. Further analysis of these data is ongoing.
COPD affects more than 300 million people globally, with up to 40% of patients exhibiting type 2 inflammation characterized by raised blood eosinophil count, which drives exacerbations.
The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities.
Nucala is already approved as&nbsp;an add-on, prescription maintenance treatment for patients six and older with severe eosinophilic asthma.&nbsp;
Nucala&nbsp;is currently not indicated for COPD anywhere in the world.
The drug contributed 6% to GSK&#8217;s 2023 sales, with revenue of 1.65 billion pounds, up 18% at CER <a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36866039/gsk-upgrades-long-term-outlook-after-q4-performance-shingrix-vaccine-and-newly-launched-rsv-vacci" rel="noreferrer noopener">year over year</a>.
In June, the FDA approved Verona Pharma plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRNA#NASDAQ">VRNA</a>) Ohtuvayre (ensifentrine) for the maintenance treatment of <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39526177/first-inhaled-copd-therapy-in-over-2-decades-fda-approves-verona-pharmas-first-commercial-product" rel="noreferrer noopener">COPD in adult patients</a>.
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
Price Action: GSK stock is up 0.86% at $43.50 during the premarket session at last check Friday.
Photo via Shutterstock
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Equities

VRNA

GSK's Asthma Drug Meets Main Goal In Phase 3 Study In Patients With Smoker's Lungs, Prepares Competition With Amgen/AstraZeneca's Drug

GSK's MATINEE Phase 3 Trial Of Nucala (Mepolizumab) Met The Primary Endpoint Showing A Statistically Significant And Clinically Meaningful Reduction In The Annualized Rate Of Moderate/Severe Exacerbations Versus Placebo In Chronic Obstructive Pulmonary Disease

WIIM

GSK shares are trading higher after a Delaware court said it will hear an appeal by the company related to Zantac.

GSK Statement On Zantac (Ranitidine) Litigation; Delaware Supreme Court To Review Superior Court's Daubert Decision

CORRECTION: GSK FDA Breakthrough Therapy News Was Reported On August 20

The recent move by the U.S. government to negotiate Medicare drug prices has triggered speculation about which drugs could be targeted in the next round of negotiations, which is set for 2027.
Last week, the&nbsp;Biden administration announced that Medicare's newly negotiated prescription drug prices are expected to save the U.S. government<a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40397706/biden-administration-targets-6b-savings-through-medicare-drug-price-negotiations" rel="noreferrer noopener"> $6 billion in the first year alone</a>.
According to some analysts, Novo Nordisk A/S' (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) blockbuster diabetes drug Ozempic might be included, along with several other well-known medications.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422798/doctors-struggle-to-secure-medicare-coverage-for-heart-patients-on-novo-nordisks-wegovy" rel="noreferrer noopener">Doctors Struggle to Secure Medicare Coverage for Heart Patients on Novo Nordisk's Wegovy</a>.
These could include Pfizer Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) cancer drugs Ibrance and Xtandi, GSK Plc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) asthma treatment Trelegy Ellipta, Teva Pharmaceutical Industries Ltd.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) Huntington's disease drug Austedo, and Abbvie Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) irritable bowel syndrome treatment Linzess.
The list would focus on drugs available since at least 2017, primarily those on which Medicare spends heavily.
Under President Joe Biden's Inflation Reduction Act (IRA), the prices of 10 popular Medicare drugs will be reduced by up to 79% in 2026.
This move has faced resistance from the pharmaceutical industry, which argues that such measures could stifle innovation. Government officials, however, maintain their commitment to reducing healthcare costs.
Despite concerns about the impact on pharmaceutical companies, a Reuters report suggests the financial blow might be less severe than anticipated.
Company executives appear to be cautiously optimistic. Pfizer's Chief U.S. Commercial Officer, Aamir Malik, stated that the timing of patent expirations for Ibrance and Xtandi could allow the company to manage the price negotiations effectively.
Similarly, Teva CEO Richard Francis acknowledged the potential impact of price cuts but remained confident in Austedo's growth prospects, forecasting $2.5 billion in earnings by 2027.
Abbvie's CEO expressed a similar sentiment, indicating that their long-term outlook remains intact, even considering future negotiations.
Regulators will announce up to 15 more drugs for negotiation in 2028, potentially expanding the scope to include medications covered under Medicare's Part B program.
As drug negotiations progress, the Congressional Budget Office estimates that savings from the IRA will rise to $9.4 billion by 2027, marking a significant step in the government's effort to reduce healthcare costs.
Price Action: NVO stock is down 0.64% at $136 at last check Friday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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