GlaxoSmithKline PLC (GSK)

[idpickering]

ViiV Healthcare receives approval from China's National Medical Products Administration (NMPA) for Vocabria (cabotegravir) used in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment.

https://www.investegate.co.uk/announcem ... na/7839933

Ian.

[idpickering]

Phase III RUBY trial of Jemperli (dostarlimab) plus chemotherapy meets endpoint of overall survival in patients with primary advanced or recurrent endometrial cancer.

GSK plc (LSE/NYSE: GSK) today announced positive headline results from a planned analysis of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin and paclitaxel), followed by dostarlimab as a single agent, compared to placebo plus chemotherapy followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. The trial met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful benefit in the overall patient population.

A clinically meaningful OS benefit was observed in both prespecified subpopulations in the trial: mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroups. OS is one of two primary endpoints in the RUBY Part 1 trial. Previously, the trial met its other primary endpoint of progression-free survival (PFS), demonstrating a 72% and 36% reduction in the risk of disease progression or death observed in the dMMR/MSI-H population (HR: 0.28 [95% CI: 0.16-0.50]) and overall patient population (HR: 0.64 [95% CI: 0.51-0.80]), respectively[1].

https://www.investegate.co.uk/announcem ... t-/7846173

Ian.

[idpickering]

3rd Quarter Results.

Broad-based execution drives further sales and earnings growth:

Total Q3 2023 sales +10% and +16% ex COVID

Vaccines sales +33%, +34% ex COVID. Shingrix £0.8 billion +15%, Arexvy sales £0.7 billion

Specialty Medicines sales -1%, +17% ex COVID with HIV +15%

General Medicines sales -2% with impact of generic competition to older products, in part offset by Trelegy +23%

Total operating profit and Total continuing EPS reflects strong growth in the quarter and year to date with lower charges for contingent consideration liabilities remeasurement

Adjusted operating profit +15% and Adjusted EPS +17% reflects strong execution, resilient growth and higher royalty income in part offset by increased investment in R&D, new product launches and a seven percentage point operating profit reduction from lower COVID-19 solutions sales

And later;

Quarterly dividends

The Board has declared a third interim dividend for 2023 of 14p per share (Q3 2022: 13.75p(4) per share).

The ex-dividend date will be 16 November 2023, with a record date of 17 November 2023 and a payment date of 11 January 2024.

https://www.investegate.co.uk/announcem ... ts/7851912

Ian (I hold).

[idpickering]

GSK receives positive CHMP opinion for momelotinib.

GSK today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of momelotinib for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

https://www.investegate.co.uk/announcem ... ib/7876187

Ian.

[idpickering]

GSK announces positive DREAMM-7 headline results.

GSK today announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma. The trial met its primary endpoint of progression-free survival (PFS) and showed that belantamab mafodotin when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma. A strong and clinically meaningful overall survival (OS) trend with nominal p value < 0.0005 was also observed at the time of this analysis, and the trial continues to follow up for OS.

https://www.investegate.co.uk/announcem ... s-/7903568

Ian (I hold).

[monabri]

https://www.investegate.co.uk/announcem ... es/7920614

[idpickering]

Jemperli plus chemotherapy EU authorisation.

GSK's Jemperli (dostarlimab) plus chemotherapy approved as the first and only frontline immuno-oncology treatment in the European Union for dMMR/MSI-H primary advanced or recurrent endometrial cancer

https://www.investegate.co.uk/announcem ... n-/7933138

Ian.

[idpickering]

Japan accepts Arexvy filing for at risk adults.

Japan's Ministry of Health, Labour and Welfare accepts Arexvy regulatory application to prevent RSV disease in adults aged 50-59 at increased risk

https://www.investegate.co.uk/announcem ... ts/7935742

Ian.

[idpickering]

emperli plus Zejula Trial Meets Endpoint.

Jemperli (dostarlimab) plus Zejula (niraparib) combination significantly improved progression-free survival in primary advanced or recurrent endometrial cancer in RUBY Part 2 Phase III trial

https://www.investegate.co.uk/announcem ... t-/7947231

Ian.

[idpickering]

GlaxoSmithKline Pulls Back Inhaler Patents After US FTC Warning Letter

GlaxoSmithKline Plc and an Amneal Pharmaceuticals Inc. unit agreed to delist patents on some older inhalers and injectors from a US Food and Drug Administration registry, potentially accelerating the approval of generic versions.

The delistings from the FDA’s Orange Book of drug patents came in response to the Federal Trade Commission, which sent warning letters to 10 pharmaceutical entities last month. The agency argued that the targeted patents don’t cover actual inventions or aren’t valid and gave the companies 30 days to delist or recertify them.

https://www.msn.com/en-us/money/compani ... r-AA1lO3LT

Ian.

[idpickering]

GSK enters agreement to acquire Aiolos Bio

GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments.

The acquisition provides GSK with access to Aiolos' AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps. AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui).

Tony Wood, Chief Scientific Officer, GSK, said: "We have a proud heritage and deep development expertise in respiratory medicines, especially addressing diseases driven by IL-5 with high levels of eosinophils or high T2 inflammation. Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed."

https://www.investegate.co.uk/announcem ... o-/7980198

Ian.

[bluedonkey]

Thanks for your post Ian.

Despite all the news from GSK over many years, it seems to have little effect on the financial success of the business or the share price.

[idpickering]

Thanks for your post Ian.

Despite all the news from GSK over many years, it seems to have little effect on the financial success of the business or the share price.

You're welcome. I no longer hold GSK, but sometimes wish I still did. Hmm?... I now only have AZN in the sector. I tend to focus on dividends nowadays, and GSK hasn't been much of a blinding buy on that metric either imho. I agree with your comment though. Let's see what happens on market opening today.

Ian.

[idpickering]

Further to the above, GSK are up 0.14% on opening, with AZN being up 0.8% currently. Par for course with GSK methinks, despite the 'news' above?

Ian.

[idpickering]

Nucala approved in China for use in severe asthma

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved for use in China for adult and adolescent patients with this condition.

Asthma is a major health burden in China affecting an estimated 46 million adults.1 Of those, approximately 6% experience severe asthma, which confers the most substantial impact on daily living, is associated with an increased risk of exacerbations requiring hospitalisation, and higher likelihood of potentially fatal asthma attacks.1-5 In China, 15.5% of people with asthma have experienced an exacerbation requiring a hospital visit in the preceding 12 months.1

https://www.investegate.co.uk/announcem ... ma/7982214

Ian (No holding).

[idpickering]

GSK completes sale of shares in Haleon

GSK plc (LSE/NYSE: GSK) today announced that, further to its announcement on 16 January 2024, GSK has agreed to sell 300m ordinary shares in Haleon plc ("Haleon") at a price of 326 pence per share (the "Placing Shares"), raising gross proceeds of approximately £978m (the "Placing").

Following settlement of the Placing, GSK will hold approximately 385m ordinary shares in Haleon, representing approximately 4.2% of the issued share capital of Haleon.

GSK and Pfizer Inc. (which holds a 32% stake in Haleon), have each undertaken not to dispose of any further shares in Haleon for a period of 60 days following settlement of the Placing, subject to certain customary exceptions and waiver by BofA Securities and Citigroup Global Markets Limited.

https://www.investegate.co.uk/announcem ... lc/7992480

Ian (No holding in either share).

[idpickering]

European Commission authorises GSK's Omjjara (momelotinib)

GSK plc today announced the European Commission* granted marketing authorisation for Omjjara (momelotinib), a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. Omjjara is the first authorised medicine in the EU for disease-related splenomegaly (enlarged spleen) or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

https://www.investegate.co.uk/announcem ... u-/8009456

Ian.

[idpickering]

EMA accepts Arexvy filing for adults 50-59 at risk

GSK plc today announced that the European Medicines Agency (EMA) has accepted the company's regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If accepted, GSK's RSV vaccine would be the first vaccine available to help protect this population. Arexvy is currently approved in Europe in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.

https://www.investegate.co.uk/announcem ... sk/8009731

Ian.

[idpickering]

GSK delivers strong 2023 performance and upgrades growth outlooks.

Broad-based performance drives sales, profits and earnings growth:

Total 2023 sales £30.3 billion +5% and +14% ex COVID

Vaccines sales +25%, +24% ex COVID. Shingrix £3.4 billion +17%, Arexvy £1.2 billion

Specialty Medicines sales -8%, +15% ex COVID with HIV +13%; General Medicines sales +5%

Total operating profit and Total continuing EPS for 2023 reflects strong growth, with lower charges for contingent consideration liabilities remeasurement

Adjusted operating profit +12% (with further positive impact of +4% ex COVID) and Adjusted EPS +16% (with further positive impact of +6% ex COVID). This reflected strong sales ex COVID and higher royalty income, partly offset by increased investment in R&D and new product launches

And later;

Quarterly dividends

The Board has declared a fourth interim dividend for 2023 of 16.00p per share (Q4 2022: 13.75p(3) per share).

Dividends remain an essential component of total shareholder return and GSK recognises the importance of dividends to shareholders. On 23 June 2021, at the GSK Investor Update, GSK set out that from 2022 a progressive dividend policy will be implemented guided by a 40 to 60 percent pay-out ratio through the investment cycle. Consistent with this, and reflecting strong business performance during the year, GSK now expects to declare an increased dividend of 16.00p for Q4 2023 and 58.00p per share for full year 2023. The expected dividend for 2024 is 60.00p. In setting its dividend policy, GSK considers the capital allocation priorities of the Group and its investment strategy for growth alongside the sustainability of the dividend.

Payment of dividends

The equivalent interim dividend receivable by ADR holders will be calculated based on the exchange rate on 9 April 2024. An annual fee of $0.03 per ADS (or $0.0075 per ADS per quarter) is charged by the Depositary. The ex-dividend date will be 22 February 2024, with a record date of 23 February 2024 and a payment date of 11 April 2024.

https://www.investegate.co.uk/announcem ... ts/8013825

Ian (No holding).

[idpickering]

Statement: Zantac (ranitidine) litigation

GSK plc today confirmed it has reached a confidential settlement with David Browne, resolving the case he filed in California state court. This case was set to go to trial on 20 February 2024, and instead will now be dismissed. The settlement reflects the Company's desire to avoid the distraction related to protracted litigation in this case. GSK does not admit any liability in this settlement and will continue to vigorously defend itself based on the facts and the science in all other Zantac cases.

https://www.investegate.co.uk/announcem ... n-/8016114

Ian.