 Issued: 12 September 2024, London UK
GSK announces positive headline data from phase II seasonal influenza mRNA vaccine programme
· A vaccine candidate formulation demonstrated positive A and B strain immune responses relative to standard of care in both younger and older adults
· mRNA platform elicits strong overall antibody titres with an acceptable safety profile
· Data support progression to phase III clinical trials
GSK plc (LSE/NYSE: GSK) today announced positive headline results of a phase II trial (NCT06431607) for its mRNA seasonal influenza vaccine programme. The trial 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.
In both younger and older adults, pre-defined success criteria were met. 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 II 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 programme will progress into late-stage clinical development.
GSK's Chief Scientific Officer, Tony Wood said: "This marks a significant advancement in our mRNA programme and these data support moving into late-stage development. Ultimately, our goal is to develop a new best-in-class vaccine to bring greater protection to people through the influenza season."
GSK recently signed a new licensing agreement with CureVac to assume full control of developing and manufacturing influenza and COVID-19 candidate vaccines. GSK continues to develop and optimise its mRNA capabilities through investments and partnerships, including in AI/ML-based sequence optimisation, nanoparticle design and manufacturing.
About study NCT06431607
The phase II study assesses the reactogenicity, safety, and immunogenicity of different dose levels of a modified, multivalent vaccine candidate, encoding antigens matched to all three WHO-recommended influenza strains. The study includes 250 healthy younger adults aged 18 to 64 and 250 healthy older adults aged 65 to 85. In each age group, different dose levels were tested in comparison to an age-appropriate, licensed comparator vaccine.
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Issued: 11 September 2024, London UK
Statement: Zantac (ranitidine) litigation - Dixon case
GSK plc (LSE/NYSE: GSK) today confirmed 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.
Since 2019, following the 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer.
GSK will continue to vigorously defend itself and manage this litigation in the best interests of the company and shareholders.
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 gsk.com. |
GlaxoSmithKline has announced promising results from their SWIFT-1 and SWIFT-2 phase III clinical trials of depemokimab, showing a 54% reduction in severe asthma exacerbations over a year. The biologic, intended for severe asthma patients with type 2 inflammation, is administered once every six months and has also shown to significantly reduce hospitalizations. These findings, also published in the New England Journal of Medicine, are set to inform future regulatory filings as depemokimab is not yet approved for use. |
GSK respiratory medicine Nucala's positive late-stage trial in adults with chronic obstructive pulmonary disease improves the company's long-term growth perspective, Shore Capital analyst Sean Conroy says in a note. A regulatory approval of the drug for patients with COPD could generate 0.5 billion-1 billion pounds in annual sales, offsetting part of an expected overall sales decline from 2027 as patents expire. In addition, the British pharma giant will next week present late-stage trial information regarding its additional respiratory medicine depemokimab for severe uncontrolled asthma, for which the company anticipates a potential of more than 3 billion pounds in peak year sales. |
Hi DaviusDon't suppose you (or others) have any idea when the Delaware Supreme Court might have their decision scheduled for? Just looking for timelines to guide buy/sell/trade.Thanks |
European Commission approves expanded age indication for GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk
· An estimated 20 million adults aged 50-59 in 30 European countries have a medical condition that increases their risk for RSV disease.
· Authorisation helps protect this population for the first time ahead of this RSV season
· This follows approval in US, with other countries anticipated, including Japan later this year. |
#Abdullla, just the 14:30 US market opening drag, see where we close at, the trend is very much intact from September 2022, 1800 the next barrier to clear.. :o) |
Sudden share price drop!where is the bad news ? |
In London, GSK shares rose 2.1%. The London-based pharmaceutical company welcomed the Delaware Supreme Court's decision to review the Delaware Superior Court's decision allowing the introduction of plaintiffs' expert evidence at trial regarding heartburn drug Zantac, which had been pulled off the market in 2020 at the request of the FDA.
The Delaware Supreme Court will review the Delaware Superior's Court decision according to the Daubert standard, which in the US provides criteria for evaluating whether expert testimony is admissible.
Zantac had been pulled off the market after low levels of a "probable carcinogen" were found in samples. The carcinogen, known as NDMA, is not harmful in very small amounts. However, tests showed that there were excessive quantities of NDMA in ranitidine, otherwise known as Zantac. Multiple litigations have followed.
GSK said Wednesday: "The scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer. Since 2019, there are 16 epidemiological studies looking at human data regarding the use of ranitidine, including outcomes for more than 1 million patients using ranitidine, supporting this consensus." |
REDUCED 996 @ 1642.1p ..... ;0) |
If Zantac resolved I am looking for £25. Yield here still good for a pharma and should be rising hence my recent buys and plan to add further still for a long term investment |
I think we can be ambitious for more than £18 IF the court cases are resolved satisfactorily |
Not until the court cases are over and out. |
1800 shortly imo |
UK market is massively underperforming every single day. Look at the DAX again despite a ruined German economy. I stick to what I say irrelevant of the performance of a single current darling stock |
 GSK plc (LSE/NYSE: GSK) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SENKU (formerly known as SAKIGAKE) designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB). SENKU designation is granted based on the level of innovation, severity of disease, and prominent efficacy. The goal of SENKU designation is to increase early patient access to innovative medicines through an expedited review process to treat serious conditions and fill an unmet medical need.
The designation is based on results from the phase IIb B-Clear and B-Sure trials which evaluated the efficacy, safety and durability of response of bepirovirsen in people with CHB. A confirmatory phase III programme, B-Well, is ongoing. This is the second regulatory designation in 2024 for bepirovirsen, following the US Food and Drug Administration (FDA) Fast Track designation for bepirovirsen granted earlier this year.
Further information is available at: hxxps://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-fast-track-designation-for-bepirovirsen-in-chronic-hepatitis-b. |
GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients, limited to those who are inadequately controlled with standard treatment.
Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, at GSK said: "The chronic and debilitating impact that chronic rhinosinusitis with nasal polyps can have on those affected is often underestimated. This additional indication for Nucala in Japan could provide patients with an alternative treatment option to surgery or systemic steroids." |
GSK PLC (LSE:GSK, NYSE:GSK) shares opened higher after Delaware's Supreme Court said it will hear an appeal by the UK drug maker and other pharmaceutical companies, including Pfizer, Sanofi, and Boehringer Ingelheim, to dismiss over 70,000 lawsuits alleging that the discontinued heartburn drug Zantac causes cancer.
The companies argue that the scientific methods used by plaintiffs to link Zantac to cancer are unsound. |
Even a barrage of good news only lifts the shareprice by 1% ... |
The strong pound not hitting AZN, thats a poor excuse, as it keeps hitting ATH... |
The strong £ is not helping and nor is the anticipation of everyone getting fleeced in the budget |
The yanks are a jealous lot and can't digest anyone's success specially the British,they are not going to quit. |
This company really can't catch a break from the market... |
This is the UK mkt though..... |
Yes a positive Zantac development but it's not over yet.
And who trusts US courts......
Suet |
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