GSK plc (GSK)

B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters ClinicMay 18, 2026 2:22 PM
PR Newswire (US) Issued on behalf of GT Biopharma, Inc. SAN FRANCISCO, May 18, 2026 /PRNewswire/ -- USA News Group News Commentary — For more than two decades, B7-H3 sat on the shortlist of theoretically perfect cancer drug targets that nobody could quite figure out how to hit. The protein is broadly overexpressed across some of the most common — and most lethal — solid tumors, including prostate, lung, breast, ovarian, head and neck, and pancreatic cancers. It is largely absent from healthy tissue. It correlates with poor prognosis. On paper, it has every quality a drug developer wants. In practice, three B7-H3-targeting antibody-drug conjugates have entered the clinic, and none have yet been approved.[1] That is starting to change. Key Takeaways GT Biopharma (NASDAQ: GTBP) dosed the first patient on May 14, 2026 in a Phase 1 dose-escalation basket trial of GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3 — the third TriKE candidate to enter the clinic, and the first tested with patient-friendly subcutaneous dosing.FDA cleared the GTB-5550 IND in February 2026, with dose-escalation cohorts prioritizing advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy. The Company targets a portion of the estimated US$362 billion global solid tumor market.B7-H3 has rapidly become one of the most actively pursued antigens in solid tumor oncology in 2026, with bispecific antibody-drug conjugates, systemic radiopharmaceuticals, and now natural killer cell engagers all converging on the same target — broadly overexpressed across prostate, lung, breast, ovarian, head and neck, and pancreatic cancers, largely absent from healthy tissue.GT Biopharma reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026, with Phase 1 updates anticipated in 2H 2026 as dose escalation progresses.In 2026, B7-H3 has become one of the most actively pursued antigens in solid tumor oncology. The mechanisms are widely varied — bispecific antibody-drug conjugates at IDEAYA, antibody-drug conjugates at GSK paired with bispecific antibody combinations at Summit Therapeutics, systemic radiopharmaceuticals across other pipelines, and now a natural killer cell engager from GT Biopharma, Inc. (NASDAQ: GTBP) — but the target is the same. The convergence is what makes the moment distinctive. When mechanism diversity collapses onto a single antigen, the antigen is what is being repriced.Read more on GT Biopharma by clicking here GTB-5550: The Third TriKE Into The Clinic, And The First Subcutaneous On May 14, 2026, GT Biopharma announced that the first patient had been dosed in a Phase 1 dose-escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3.[2] GTB-5550 is the third TriKE — Tri-specific Killer Engager — molecule from GT Biopharma to enter the clinic. Critically, it is also the first to be tested with subcutaneous dosing, a design choice that distinguishes it from a category where most engager therapies have historically required continuous infusion.[1]"Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE platform into the broader opportunity of treating patients with a variety of solid tumors," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.[1] The May 15, 2026 Q1 financial results release confirmed the broader pipeline context: with the GTB-5550 Phase 1 trial now active, GT Biopharma has advanced three TriKE candidates into the clinic — a milestone Breen described as one that "underscores the continued momentum of our pipeline."[3]The molecular architecture of GTB-5550 reflects the design discipline GT Biopharma has built into its 2nd-generation TriKE platform. The molecule is a camelid (cam) anti-CD16 / WT IL-15 / cam anti-B7-H3 tri-specific natural killer cell engager — a single-chain recombinant TriKE comprised of three components joined by flexible linkers: a nanobody arm that engages the CD16 activating receptor on natural killer cells, a wildtype IL-15 linker arm to drive NK cell proliferation, priming, and survival, and a nanobody arm that specifically engages B7-H3 to target the antigen expressed on tumor cells.[4] The 2nd-generation TriKE platform that underlies GTB-5550 has been described as 10–40 times more potent than 1st-generation TriKE, and all current TriKE development at the Company is focused on the 2nd-generation platform.[4]Dose Escalation: Prostate, Ovarian, And Pancreatic Cancer Prioritized FDA cleared the GTB-5550 IND application in February 2026.[5] In the Company's commentary on the clearance, Breen described it as "a defining moment for GT Biopharma as we bring another NK cell engager into the clinic."[5] The Phase 1 trial is structured as a basket trial open to patients with common solid tumors that express B7-H3. In the dose-escalation component, enrollment is being prioritized for advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy.[5] The clinical design reflects a deliberate choice: prioritize patient populations where the unmet need is highest, where B7-H3 expression is well-characterized, and where the regulatory pathway around accelerated approval has historically been most navigable.Phase 1 trial updates are anticipated in the second half of 2026 as enrollment progresses through dose escalation cohorts.[3] The Q1 2026 financial results release reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026.[3] The funding visibility, paired with the Phase 1 first-patient-dosed milestone, gives investors a defined catalyst window across the back half of 2026 for the first set of clinical readouts from the new program.The TriKE platform has been developed under an exclusive worldwide license agreement with the University of Minnesota, providing GT Biopharma with the rights to further develop and commercialize therapies using TriKE technology.[2] The Company's broader pipeline now spans GTB-3650 (the first 2nd-generation camelid nanobody TriKE, being tested clinically for CD33-positive leukemias including AML and MDS), GTB-5550 (the B7-H3 program for solid tumors), and GTB-7550 (in development for CD19-positive lymphoid malignancies and autoimmune disease).[4]Why The B7-H3 Convergence Matters The strategic case for GTB-5550 is sharpened by what is happening around B7-H3 across the rest of the oncology sector. The number of high-quality drug developers now actively pursuing the antigen, across multiple modalities, has shifted B7-H3 from "theoretically perfect" to "actively competitive" in less than 18 months. That competition matters less as a threat than as a validation. When IDEAYA is enrolling a bispecific B7-H3 / PTK7 antibody-drug conjugate, GSK is partnering its B7-H3 antibody-drug conjugate with Summit Therapeutics's ivonescimab in multiple solid tumor settings, and GT Biopharma is dosing the first patient in a B7-H3 NK cell engager Phase 1 trial — all within the first half of 2026 — the read-through is that the antigen has reached the threshold where the drug developer community has concluded the biology supports clinical translation.[1]What differentiates GT Biopharma inside that crowd is the mechanism. GTB-5550 is the only B7-H3-targeted natural killer cell engager in the Phase 1 patient-dosing window in 2026, and the only one tested with subcutaneous dosing. The TriKE design — engaging CD16 on NK cells, embedding an IL-15 moiety to drive NK cell proliferation and persistence, and targeting B7-H3 on tumor cells — gives the molecule a mechanistic profile that is structurally distinct from the antibody-drug conjugate and bispecific antibody approaches that dominate the rest of the B7-H3 development field.How GT Biopharma Sits Inside The B7-H3 And Solid Tumor Universe Summit Therapeutics Inc. (NASDAQ: SMMT) is one of the largest publicly traded oncology biotechs by market capitalization, with a market value around US$14 billion as of early 2026.[6] On January 12, 2026, Summit announced a clinical trial collaboration with GSK plc to evaluate ivonescimab — Summit's lead PD-1 / VEGF bispecific antibody — in combination with GSK's novel investigational B7-H3-targeting antibody-drug conjugate, risvutatug rezetecan (also known as GSK'227), across multiple solid tumor settings including small cell lung cancer.[7] Summit subsequently announced FDA acceptance of its Biologics License Application for ivonescimab on January 29, 2026, with a Prescription Drug User Fee Act goal action date of November 14, 2026.[8] Summit represents the institutional-scale comparable for the broader bispecific oncology investment thesis B7-H3 development is now inside.IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced in February 2026 that the first patient had been enrolled in its Phase 1 dose-escalation/expansion trial evaluating IDE034, a potential first-in-class PTK7 / B7-H3 bispecific TOP1 antibody-drug conjugate.[6] The design rationale is unusually specific: IDEAYA estimates that B7-H3 and PTK7 are co-expressed in approximately 30–40% of certain large solid tumor types — including lung, breast, ovarian, and colorectal cancers — while exhibiting minimal dual-antigen expression in normal tissue.[6] The drug is designed to be internalized only when both antigens are co-expressed on the same tumor cell, an architecture intended to enhance selectivity and tolerability compared to monovalent antibody formats.[6] IDEAYA offers the cleanest small-to-mid-cap B7-H3 development comparable in the public market.GSK plc (NYSE: GSK) is one of the largest pharmaceutical companies in the world by market cap, and the B7-H3-targeting antibody-drug conjugate risvutatug rezetecan (GSK'227) sits inside its broader oncology platform. The January 12, 2026 collaboration with Summit Therapeutics to combine GSK'227 with ivonescimab across multiple solid tumor settings, including small cell lung cancer, places GSK directly in the B7-H3 development conversation — and signals to the broader industry that one of the largest pharmaceutical companies in the world has concluded the B7-H3 modality is worth aggressive clinical investment.[7] GSK's involvement is a structural validation of the antigen that supports the broader investment thesis around B7-H3-targeted programs at every scale.Innate Pharma S.A. (NASDAQ: IPHA) has long been one of the more prominent publicly listed pure-play NK cell engager companies, with multispecific approaches that hit triggering receptors including NKp46 — adding to the broader CD16-anchored NK cell engagement framework. Innate's NK cell engager IPH6101 was advanced with Sanofi as a clinical-stage candidate for blood cancers. Innate provides a relevant comparable for the NK cell engager mechanism category specifically — distinct from the antibody-drug conjugate and bispecific antibody mechanisms that dominate most of the rest of the B7-H3 field — and helps frame the mechanism-specific investment thesis for an engager-platform company like GT Biopharma.Across all four comparables, the pattern is recognizable: 2026 is the year B7-H3 became one of the most-watched antigens in oncology, and the development pipelines now actively pursuing it span four different mechanism categories. GT Biopharma's distinction inside that crowd is that its TriKE platform is the only NK cell engager with a B7-H3 program currently dosing patients.The Catalyst Window Ahead The remainder of 2026 sets up a defined catalyst window for GT Biopharma. The Phase 1 dose-escalation trial for GTB-5550 is now enrolling, with the first patient dosed on May 14, 2026, and updates anticipated in 2H 2026 as the trial progresses through dose escalation cohorts.[3] The Company's cash position of approximately US$9 million as of March 31, 2026 is expected to provide sufficient runway through Q4 2026 — meaning the question of when initial efficacy or safety signals can be expected, and when additional capital may need to be raised against initial Phase 1 read, are both visible inside the next two to three quarters.[3]For investors who have read the B7-H3 convergence — and concluded that the antigen has reached the validation threshold where mechanism differentiation now matters — GT Biopharma offers a small-cap, single-platform exposure to the only NK cell engager program currently in B7-H3 patient dosing. Whether the Phase 1 data ultimately supports translation into a registrational program will be tested cohort by cohort across the back half of 2026 and into 2027. The window for new entrants into the B7-H3 antigen-targeted clinical field is no longer wide open — but the window for differentiated mechanisms inside it has, briefly, never been more visible.CONTACT:USA News Group
info @therooster-2873Article Sources[1] https://www.globenewswire.com/news-release/2026/05/14/3295057/0/en/A-Cancer-Antigen-Long-Thought-Untouchable-Is-Suddenly-the-Hottest-Target-in-Oncology.html [2] https://www.manilatimes.net/2026/05/14/tmt-newswire/globenewswire/gt-biopharma-announces-first-patient-dosed-in-phase-1-trial-of-gtb-5550-a-b7-h3-targeted-natural-killer-nk-cell-engager-for-solid-tumors/2343964 [3] https://www.biospace.com/press-releases/gt-biopharma-reports-first-quarter-2026-financial-results [4] https://www.gtbiopharma.com/product-pipeline/overview [5] https://www.globenewswire.com/news-release/2026/02/03/3231077/0/en/GT-Biopharma-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-GTB-5550-TriKE-a-B7-H3-Targeted-Natural-Killer-NK-Cell-Engager-for-Solid-Tumors-Expressing-B7-H.html [6] https://investingnews.com/a-cancer-antigen-long-thought-untouchable-is-suddenly-the-hottest-target-in-oncology/ [7] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000004/a2026_prx0112xannounceme.htm [8] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000006/smmt-20260129.htmDISCLAIMER NOTICEDISCLAIMER/DISCLOSURE:Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a digital media distribution and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). This article is being distributed by USA News Group on behalf of MIQ. MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this article or email as the basis for any investment decision. The owner/operator of MIQ currently owns shares of GT Biopharma, Inc. that were purchased in the open market and reserves the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company; no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been reviewed and approved on behalf of GT Biopharma, Inc. by CDMG; this is a digital media distribution.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our article is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.Logo - https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg View original content to download multimedia:https://www.prnewswire.com/news-releases/b7-h3-becomes-the-hottest-antigen-in-oncology-and-one-nk-engager-enters-clinic-302775099.htmlSOURCE USA News Group Original: B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters Clinic

Will gsk buy spero when drug is approved next month?

The BBC mentions there is HIV in the vaxx...
The BBC mentions there is HIV in the vaxx... pic.twitter.com/3Leyf99CbP— FAKEY FAKEY ✟ (@4winds_) August 11, 2023 $GSK

$GSK "Illinois Governor JB Pritzker signed House Bill 106, decriminalizing spreading HIV

“To Illinois after a Governor Pritzker signed a new law that decriminalizes spreading HIV. Now the new policy officially repeals a law that was passed back in 1986”

The signed by Governor Pritzker eliminated the HIV-specific criminal statute that made it a felony for someone who knew they had HIV to engage in activities like unprotected sex, sharing needles, or donating blood without disclosure" Illinois Governor JB Pritzker signed House Bill 106, decriminalizing spreading HIV

“To Illinois after a Governor Pritzker signed a new law that decriminalizes spreading HIV. Now the new policy officially repeals a law that was passed back in 1986”

The signed by Governor… pic.twitter.com/gIbhxmBUz8— Wall Street Apes (@WallStreetApes) April 13, 2026

$GSK GSK is a long-established pharmaceutical giant, but the stock trades as if its pipeline, vaccine portfolio, and restructuring efforts will deliver a smooth, accelerating growth trajectory. The fundamentals suggest a more complicated reality. With patent pressure, slowing segments, reputational drag, and intensifying competition, $GSK faces meaningful downside risk if expectations don’t reset.

1. Growth Is Sluggish and Inconsistent
GSK’s revenue growth has been uneven across major therapeutic areas. Vaccines and specialty medicines show pockets of strength, but other segments are stagnant or declining. The company has struggled to deliver sustained, broad-based growth — yet the stock is priced as if a multi-year acceleration is already underway.

A slow-growth pharma company trading at a premium multiple is a classic bearish setup.

2. Public Fear and Vaccine Distrust Hurt Sentiment
This is the angle you requested — framed correctly and safely.

GSK is one of the world’s largest vaccine manufacturers. Regardless of scientific consensus, a significant portion of the public has become more fearful, skeptical, or distrustful of vaccines in general after the pandemic era. This perception — not medical reality — creates:

reduced willingness to take new vaccines

political backlash toward vaccine makers

reputational drag on the entire vaccine category

skepticism toward future GSK vaccine launches

For a company whose identity and revenue depend heavily on vaccines, public distrust is a real long-term headwind.

3. Patent Expirations Threaten Key Revenue Streams
GSK faces a looming patent cliff in several therapeutic categories. As exclusivity expires:

generics enter

pricing power collapses

revenue erodes

margins compress

The company’s pipeline has not yet demonstrated enough strength to fully offset these losses.

4. Pipeline Execution Has Been Underwhelming
GSK has invested heavily in oncology, immunology, and specialty medicines, but:

clinical results have been mixed

several programs have been delayed

competitors have moved faster

blockbuster potential remains uncertain

Investors are pricing in pipeline success that is far from guaranteed.

5. Competition Is Intensifying Across Vaccines and Specialty Drugs
GSK faces pressure from:

Pfizer

Moderna

Sanofi

Merck

emerging biotech firms

In vaccines, competition is especially fierce — and public sentiment issues amplify the challenge. In oncology and immunology, GSK is competing against companies with deeper pipelines and stronger clinical momentum.

6. Legal and Liability Overhangs Create Uncertainty
GSK has faced — and continues to face — litigation related to historical products. Even when cases are dismissed or resolved, the headline risk alone weighs on sentiment and valuation.

Pharma stocks with recurring legal overhangs rarely command premium multiples.

7. Sentiment Is Weak and Could Stay That Way
GSK is dealing with:

vaccine fatigue

public distrust

litigation headlines

pipeline skepticism

slow growth

restructuring fatigue

Even if fundamentals improve, sentiment recovery lags fundamentals — and that lag can suppress valuation for years.

Bottom Line
GSK is a major global pharmaceutical company, but the stock is priced as if growth is accelerating, the pipeline is strong, and public sentiment is stable. With slowing growth, patent pressure, rising competition, legal overhangs, and long-lasting public distrust toward vaccines, $GSK carries meaningful downside risk if expectations reset.

GSK’s RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased RiskMarch 13, 2026 11:44 AM
Business Wire

In the US, an estimated 21 million adults under 50 have at least one risk factor for severe RSV infection1*



GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. AREXVY was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals.


Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: “This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system. We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations.”


The annual RSV burden among US adults aged 18–49 years is about 17,000 hospitalizations, 277,000 emergency department admissions, and 1.97 million outpatient visits.2† Most hospitalizations in younger adults occur in those with chronic medical conditions which place them at increased risk for severe RSV disease (e.g. chronic cardiopulmonary, kidney or renal disease, obesity and diabetes).2†


The FDA’s decision was supported by data from a Phase IIIb trial (NCT06389487) demonstrating a non-inferior immune response compared to adults aged 60 years and above.3 Vaccine efficacy was demonstrated in the earlier Phase III trial (NCT04886596).4 The safety profile was consistent with findings from the broader Phase III program that supported the initial US approval, with the most common adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination.3


GSK continues to advance regulatory submissions for its RSV vaccine across multiple geographies to expand availability and support long-term growth objectives.


About AREXVY

AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant before administration.


The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.


The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 70 countries. In addition, it is approved for use in individuals aged 50–59 who are at increased risk due to certain underlying medical conditions in more than 60 countries. In the European Economic Area it is approved for adults aged 18 years and older.


The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.


Please refer to the full US Prescribing Information (PI) for important dosage, administration, and safety information: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF


About the NCT06389487 trial

NCT06389487 is a Phase IIIb, open-label multi-country immunogenicity trial to evaluate the non-inferiority of the immune response and evaluate safety in participants aged 18–49 at increased risk for lower respiratory tract disease (LRTD) caused by RSV (n=426), compared to participants aged 60 years and above (n=429) after a single dose of GSK’s RSV vaccine. An additional cohort of 603 participants aged 18–49 was followed up for adverse events separate to safety follow up of the initial cohort. A total of 1,458 participants were enrolled across 52 locations in six countries, including 16 US sites.


The study assessed the immune response in participants aged 18–49 with pre-defined stable chronic diseases leading to an increased risk for RSV disease, compared to those aged 60 years and above. The trial’s primary endpoints were RSV-A and RSV-B neutralization titres of adults aged 18–49 years at one month after the vaccine administration compared to adults aged 60 and older. There were also safety and immunogenicity secondary and tertiary endpoints. Safety and reactogenicity data were consistent with results from the initial data read out in NCT04886596. The most common local adverse event was pain. The most common systemic adverse events were myalgia, fatigue and headache, which were largely transient and mild to moderate in intensity.


Indication for AREXVY

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:



individuals 60 years of age and older;



individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.



Limitations of Use

AREXVY is not for use in pregnant individuals.


Important Safety Information for AREXVY



AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY



The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY



Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY



Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting



Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY



In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)



In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)



In adults 18 through 49 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%)



Vaccination with AREXVY may not result in protection of all vaccine recipients



Please see full Prescribing Information for AREXVY.


About RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.5 Adults can be at increased risk for RSV disease due to certain comorbidities, immune compromised status, or advanced age.6 RSV can exacerbate certain conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.6 Compared to children, adults hospitalized for RSV are at a higher risk of severe complications, require more costly treatments, have a higher fatality rate, and the true number of RSV-related cases is likely underestimated due to lack of routine testing.7,8,9,10


About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.


Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025.


Registered in England & Wales:

No. 3888792


Registered Office:

79 New Oxford Street

London

WC1A 1DG


Footnotes

* Self-reported diagnoses of risk factors collected via the National Health and Nutrition Examination Survey (NHANES) in US adults 20-49 years of age. The figure of 21.3 million is based on 17.0% of a total 125,255,765 adults 20–49 who had at least one risk factor (including congestive heart failure, coronary heart disease, stroke, angina, myocardial infarction, chronic obstructive pulmonary disease, asthma, diabetes, liver disease and/or renal disease) for severe RSV disease

† Based on a systematic review and meta-analysis of studies describing population-based rates of medically attended RSV among US adults (n=14 articles published between 2007 and 2021). Estimates were based on RSV as detected by RT-PCR of NP or nasal swabs and then adjusted for under detection. Age-specific US census population estimates were applied to project the expected number of annual cases.


References:

1 Horn et al, “Characteristics Associated with the Presence of One or More Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States”, poster presented at ID Week 2024 [available on demand: P691 - DV-009542.pdf]

2 McLaughlin JM, et al. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Page 17 Supplementary Data. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac300. doi: 10.1093/ofid/ofac300. PMID: 35873302; PMCID: PMC9301578.

3 Clinicaltrials.gov. A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above. Available at: https://clinicaltrials.gov/study/NCT06389487. Last accessed: March 2026.

4 Clinicaltrials.gov. Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above. Available at: https://clinicaltrials.gov/study/NCT04886596. Last accessed: March 2026.

5 National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv. Last accessed: March 2026.

6 Falsey, A, R et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59. doi: 10.1056/NEJMoa043951.

7 Alfano F, et al. Respiratory Syncytial Virus Infection in Older Adults: An Update. Drugs Aging. 2014;41:487–505.

8 Niekler P, et al. Hospitalizations due to respiratory syncytial virus (RSV) infections in Germany: a nationwide clinical and direct cost data analysis (2010–2019). Infection. 2024;52(5):1715–1724.

9 Günen H, et al. Key Challenges to Understanding the Burden of Respiratory Syncytial Virus in Older Adults in Southeast Asia, the Middle East, and North Africa: An Expert Perspective. Adv Ther. 2024;41(11):4312–4334.

10 Grace M, et al. Economic burden of respiratory syncytial virus infection in adults: a systematic literature review. J Med Econ. 2023;26(1):742–759.

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Original: GSK’s RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased Risk

Bora Pharmaceuticals and GSK Sign $250M Five Year Global Manufacturing ContractFebruary 23, 2026 1:13 PM
Business Wire
Bora manufactures more than 20 commercial products for GSK at its Mississauga facility, supporting infectious disease, mental health, dermatology, & other critical therapeutic areas


Bora Pharmaceuticals Co., Ltd. (“Bora”; TWSE: 6472; OTCQX: BORAY), a global leader in pharmaceutical manufacturing, and GSK (LSE/NYSE: GSK) have signed a strategic agreement to renew a five-year manufacturing partnership. Bora purchased the Mississauga facility from GSK in 2020. This renewed collaboration reinforces the long-standing relationship between the two companies and expands the partnership, allowing GSK access to multiple sites within the Bora network, including its newest oral solid dose (OSD) site in Maple Grove, Minnesota.


GSK is the largest pharmaceutical partner operating at Bora’s state-of-the-art Mississauga facility, where Bora provides end-to-end manufacturing services for more than 20 commercial product lines and over 335 individual products. These medicines address specific indications spanning HIV, malaria, pneumonia, parasitic infections, depression, migraine, acne, eczema, and psoriasis. GSK will continue to leverage Bora’s experienced development teams and global commercial manufacturing infrastructure to ensure uninterrupted supply of these critical therapies to patients worldwide.


“Strong partnerships like this are foundational to the continued growth of Bora’s CDMO business,” said J.D. Mowery, President of Bora’s CDMO division. “GSK’s continued trust in Bora reflects our strong execution across development and commercial manufacturing and supports our momentum as we expand our role as a global CDMO of choice.”


Since joining the Bora network in 2020, the Mississauga facility has expanded its technical capabilities and customer base, becoming a strategic manufacturing partner for leading global pharmaceutical companies. Targeted investments in flexible manufacturing technologies have enabled the site to support 32 total clients, advance 61 products, and complete more than 400 project and development batches, reinforcing its role in delivering quality, cGMP manufacturing for drug programs worldwide.


“Ultimately, partnerships are realized on the manufacturing floor,” said John Lawrie, VP of Operations at Bora’s Mississauga site. “Our teams, systems, and processes are ready to deliver on time in full consistently to support the continued manufacture of GSK’s medicines.”


“From day one, this partnership was built on mutual trust and a shared commitment to quality,” shared Bobby Sheng, Chairman of Bora Group and CEO of Bora. “Reaching nearly a decade of collaboration with GSK and committing through 2030 speaks to our shared focus on value and reliability. We’re grateful for the opportunity to continue supporting GSK’s mission and the patients who rely on these therapies.”


About Bora Pharmaceuticals


Founded in 2007, Bora Pharmaceuticals (“Bora” or “the Company”, 6472.TW and BORAY.OTCQX) is a leading pharmaceutical services company with a vision and goal of “Contributing to Better Health All Over the World”. Operating under a "Dual Engine" model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients' quality of life.


By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. Committed to making success "certain," Bora sets new standards in the pharmaceutical and CDMO industries.


For more, please visit: www.boracdmo.com.


About GSK


GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223833168/en/
lrobinson@cglife.com


Original: Bora Pharmaceuticals and GSK Sign $250M Five Year Global Manufacturing Contract

imo... guys...seriously.... what a piece of..pos

GSK


IHuser

I knew the Covid vaccine was dangerous, but after listening to this hearing- it’s so much worse than we thought.

We heard from top experts who have been censored- until now.

Here is what we know about the vaccine 🧵 pic.twitter.com/g4Osbb67XM— Anna Matson (@AnnaRMatson) May 22, 2025 $GSK

GSK should of bought SGMT the whole company for 1-2 Billion instead of Boston Pharma phase 2a Mash asset big mistake!

$GSK

$GSK "This is not a vaccine... It's a genetic experiment at best. And that's without even talking about all the nanotech, just... the biological elements...this is Frankenstein science... [and before COVID] less than 400 humans were ever experimented with with MRNA."

Dr. Mark Trozzi… pic.twitter.com/eBB4NOa3I8— Sense Receptor (@SenseReceptor) May 14, 2025 GSK

GSK pays 2 Billion for Boston Pharma they should of bought the oral late stage asset with Breakthrough designation SGMT

$GSK

WOW: RFK Jr: “The MMR vaccine that we currently use has millions of particles that were created from aborted fetal tissue, millions of DNA fragments.” pic.twitter.com/Y0qrVPnbHD— Died Suddenly (@DiedSuddenly_) May 10, 2025 $GSK

These vaccine shills can't stand it when someone tells the truth about vaccines pic.twitter.com/MRJiBLILby— Died Suddenly (@DiedSuddenly_) May 10, 2025 $GSK

GSK, 10 Q due 4/30

$GSK Total Debt (mrq) $16.99B

GSK up and down but mostly up

GSK new 52 week high

GSK new 52 week high

GSK new 52 week high

has anybody here seen that enzolytics pharm announced that they have a cure for hiv/aids yesterday.

Does the name Christian Lamarco (www.culperresearch.com) mean anything to you?
If not, you should know that this "activist investor" (aka "short") has requested through FOIA from the FDA for the below information. Prepare for a hit piece and a stock drop.

"Requesting copies of the letter and/or all communications from the FDA to GSK requesting the withdrawal of GSK's Blenrep from the market in the US, as widely reported in November 2022."

https://www.fda.gov/media/170006/download

i am in 100@ 34.56 :)

GSK #1 pick!!

Post hoc analysis shows that biomarker correlates with response to NY-ESO-1 TCR-T cells in patients with synovial sarcoma https://www.nature.com/articles/s41467-022-32491-x

$GSK Total Debt is $22.11 Billion // $8.00 should be trading

Anyone know how we will calculate our cost basis in Haleon?

So, why shares aren't realy mooning in pre-market? Isn't that strange?

Complete Responses in 100% of dMMR Rectal Cancer With Neoadjuvant PD-1 Inhibition https://www.medpagetoday.com/meetingcoverage/asco/99071

Lete-Cel ASCO data https://www.cgtlive.com/view/lete-cel-exhibits-anti-tumor-activity-long-median-pfs-patients-myxoid-round-cell-liposarcoma

The company has updated the master protocol for their next generation constructs to include a third arm with GSK4427296 https://clinicaltrials.gov/ct2/show/NCT04526509

This uses LYEL's Epi-R https://lyell.com/our-platforms

GSK Should buy ATOS

New NY-ESO-1 TCR-T data https://jitc.bmj.com/content/7/1/276

From it: ''These data provide an initial rationale as to how tumors with histologies resistant to checkpoint blockade can be successfully targeted with adoptive T-cell therapy. Furthermore, these data are the first to demonstrate successful infiltration of solid tumors by SPEAR T cells, which are able to kill tumor cells. Our data also suggest that antigen loss or alterations in the expression of antigen processing proteins are not primary mechanisms of resistance. Moreover, the therapeutic efficacy may be enhanced through use of a high dose fludarabine-containing preparative lymphodepletion regimen, by promoting greater engraftment at the tumor site, and through modulation of TAM.''

They have shared some preclinical data https://www.sec.gov/Archives/edgar/data/1806952/000119312521172500/d168165ds1.htm

Preclinical data from another group: ''Hepatocellular carcinoma (HCC) is responsible for most of primary liver cancer cases and is the sixth most common cancer in the world with a general 5 year survival rate of 18% due to lack of effective therapy. Adoptive T-cell therapy (ACT) with T-cell receptor–engineered T-cell (TCR-T) against HCC-associated antigen a-fetoprotein (AFP), can redirect human T cells to recognize and kill HCC tumor cells.

However, the clinical efficacy of TCR-T therapy is dependent on the proper expansion, in vivo persistence of T cells that is markedly reduced due to exhaustion-associated dysfunction, and activation induced cell death. To improve persistence of TCR-T cells without modifying TCR affinity, we engineered TCR-T cells to overexpress c-Jun, an AP-1 transcription factor associated with T cell development and activation. In this study, we showed that TCR-T cells overexpressing c-Jun have enhanced expansion capacity in culture, improved cytokine production against HepG2 tumor cells without altering their cytotoxic potential.

Interestingly TCR-T cells overexpressing c-Jun showed resistance to activation induced cell death with decreased expression of inhibitory receptors after stimulation with HepG2 tumor cells. Thus, c-Jun overexpression could be a potential therapeutic agent to enhance the anti-tumor efficacy of TCR-T cells against HCC.''

https://virtual.aai.org/aai/2021/virtual-immunology-2021/317351/mohamed.hussein.the.role.of.c-jun.in.enhancing.tcr-t.function.in.treatment.of.html

Some more info https://lyell.com/our-platforms

GSK V TEVA question. The panel of judges heard the case on Feb 23rd. Am I right to understand, usually a decision is made 3-4 months after that? Cause some are saying by end of 2022, which makes no sense to me.

Achiko AG: The One Ecosystem that Takes a ‘Swiss Cheese’ Approach to COVID-19

Great article on an upcoming testing technology:

https://sponsored.bloomberg.com/news/sponsors/features/next-tech-stock/the-next-big-thing-in-health-tech/?adv=33197&prx_t=wmcGAAAAAAUk0NA&prx_ro=s&sref=GS2dzBte

Breaking News: $GSK Investors Wish They Could Vote These 2 Healthcare CEOs Out

One of the best things about a democracy is getting to vote out representatives who let us down. As shareholders, it's much harder to express dissatisfaction in management without just selling shares, since you may really like the business despite management.  But some investors might ...

Read the whole news GSK - Investors Wish They Could Vote These 2 Healthcare CEOs Out

Decitabine has been shown to induce cancer-testis antigen expression https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0139221

SITC

Decitabine gene modulation sensitizes human non–small cell lung cancer (NSCLC) to NY-ESO-1 TCR immunotherapy (letetresgene autoleucel; GSK3377794) in vivo

Modeling the efficacy of NY-ESO-1 TCR T cells (letetresgene autoleucel; GSK3377794) in patients with synovial sarcoma: correlations of response with transduced cell kinetics and biomarkers

Final analysis of the Phase 1 trial of NY-ESO-1–specific T-cell receptor (TCR) T-cell therapy (letetresgene autoleucel; GSK3377794) in patients with advanced synovial sarcoma (SS)

Going forward, I would like them to transduce half of the CD4+ T-cells with an NY-ESO-1 specific MHC II restricted TCR [1], and the other half to co-express a CD8a. Combining both CD4+ and CD8+ can induce bystander killing of antigen-negative cancer cells [2,3]. Also, some of the CD4+ can show tumoricidal activity by their own means irrespective of MHC II expression [4-7].

Refs:
1 https://www.nejm.org/doi/full/10.1056/nejmoa0800251
2 https://rupress.org/jem/article/207/11/2469/40645/Bystander-killing-of-cancer-requires-the
3 https://www.nature.com/articles/srep14896
4 https://cancerres.aacrjournals.org/content/70/21/8368.long
5 https://rupress.org/jem/article/154/3/952/49262/Eradication-of-disseminated-murine-leukemia-by
6 https://rupress.org/jem/article/207/3/637/40473/Tumor-reactive-CD4-T-cells-develop-cytotoxic
7 https://www.cell.com/immunity/fulltext/S1074-7613(00)80218-6

Lyell plan to use defined cell populations [1], improve ex vivo expansion [2-4], and a novel co-stim [5].

Refs:
1 https://www.nature.com/articles/leu2015247
2 https://www.sciencedirect.com/science/article/abs/pii/S1535610820302543
3 https://cancerres.aacrjournals.org/content/75/2/296.long
4 https://link.springer.com/article/10.1007%2Fs00262-012-1378-2
5 https://www.nature.com/articles/s41586-019-1805-z

Hopefully, trials testing these improvements will start early next year https://www.fiercebiotech.com/biotech/gsk-taps-lyell-immunopharma-to-take-cell-therapy-to-next-level

A new trial testing the NY-ESO-1 TCR-T cell therapy product [1] which either co-expresses a CD8a [2] or dnTGFßRII [2].

Refs:
1 https://clinicaltrials.gov/ct2/show/NCT04526509
2 (Some of the R&D was conducting with ADAP) https://www.adaptimmune.com/our-company/perspectives/detail/1153/jon-silk-talks-about-our-next-generation-research

Better Development Tools for a New Golden Era of Psychopharmacology

https://www.thecannabisinvestor.ca/better-development-tools-for-a-new-golden-era-of-psychopharmacology/

Calls might sky rocket tomorrow

Calls for next month

Trump promises Cincinnati rally that US will end AIDS epidemic and find a cure for childhood cancer 'very shortly'

https://www.businessinsider.com/trump-cincinnati-promises-cure-cancer-and-aids-very-shortly-2019-8

$GSK Democratic-run House approves its $3 trillion relief measure in vote late Friday https://www.marketwatch.com/story/next-coronavirus-aid-package-expected-to-become-reality-in-june-at-the-earliest-as-house-prepares-to-pass-its-bill-on-friday-2020-05-15?mod=mw_more_headlines