GSK PLC SEC Filings

GSK plc reports that the European Commission has approved a new prefilled syringe presentation of Shingrix, its Recombinant Zoster Vaccine for shingles. The current version requires healthcare professionals to reconstitute a lyophilised antigen with a liquid adjuvant from two separate vials. The new format comes as a prefilled syringe, removing the reconstitution step and making administration simpler and more convenient in clinical settings.

The approval is based on data showing technical comparability between the prefilled syringe and the existing presentation, with no changes to the vaccine’s indication or dosing. Shingrix continues to be authorised in the European Union to prevent herpes zoster and post‑herpetic neuralgia in adults from age 50, and from age 18 for those at increased risk. GSK plans to begin rolling out the prefilled syringe across EU countries in 2026, aiming to support broader and easier protection against shingles, which affects around 1.7 million people in Europe each year.

GSK plc reports that its two pivotal phase III trials, B-Well 1 and B-Well 2, for bepirovirsen in chronic hepatitis B met their primary endpoint and all ranked endpoints. Bepirovirsen, an investigational antisense oligonucleotide, achieved a statistically significant and clinically meaningful functional cure rate, with higher cure rates when added to standard nucleos(t)ide analogue therapy compared with standard of care alone, and an acceptable safety and tolerability profile.

Chronic hepatitis B affects more than 250 million people worldwide and accounts for about 56% of liver cancer cases, while current therapies typically deliver only around a 1% functional cure rate. GSK plans global regulatory filings for bepirovirsen from Q1 2026 and indicates the therapy could become the first finite, six‑month treatment option for chronic hepatitis B and a backbone for future sequential treatment strategies if approved.

GSK reports that Japan's Ministry of Health, Labour and Welfare has approved Exdensur (depemokimab) for severe or refractory bronchial asthma and for chronic rhinosinusitis with nasal polyps (CRSwNP) in patients inadequately controlled on standard treatment.

Exdensur is described as the first ultra-long-acting biologic in Japan for these conditions, given as just two injections a year. In the SWIFT-1 and SWIFT-2 phase III trials, adding depemokimab to standard care cut annualised severe asthma exacerbation rates by 58% and 48% versus placebo over 52 weeks. In the ANCHOR-1 and ANCHOR-2 trials for CRSwNP, patients showed meaningful reductions in nasal polyp size and nasal obstruction scores compared with placebo.

Across these late-stage studies, depemokimab had a tolerability profile similar to placebo. This Japan approval is the third regulatory clearance for depemokimab, following prior approvals in the US and UK, and the drug is also under review in other major markets.

GSK plc reported that two senior executives acquired ordinary shares through the company’s Share Save Plan. David Redfern, President, Corporate Development, and Victoria Whyte, SVP & Company Secretary, each exercised options granted on 28 November 2022 to buy 790 ordinary shares at an option price of £11.39 per share. The transactions, both carried out on 2 January 2026 on the London Stock Exchange, reflect routine participation in an employee share plan rather than open‑market buying. These acquisitions slightly increase each executive’s direct shareholding and align them further with the company’s equity.

GSK plc reported its share capital and voting rights position as of 31 December 2025. The company’s issued share capital consisted of 4,315,445,026 ordinary shares of 31 ¼ pence each, with 240,019,489 of these shares held in treasury and therefore not carrying voting rights. As a result, the total number of voting rights in GSK is 4,075,425,537. Shareholders can use this figure to determine whether they need to notify GSK and the UK Financial Conduct Authority of any interests or changes in their shareholdings under the Disclosure Guidance and Transparency Rules.

GSK reports that China’s National Medical Products Administration has approved Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) that remains inadequately controlled and is characterised by raised blood eosinophils. The decision is based on positive phase III MATINEE and METREX trials, where mepolizumab plus standard care produced a statistically significant reduction in the annual rate of moderate or severe COPD exacerbations versus placebo, including events leading to emergency department visits and hospitalisation.

Nucala is described as the first and only monthly biologic in China studied in a broad COPD population with blood eosinophil counts starting at 150 cells/µL. GSK notes that around 100 million people in China are living with COPD and that among patients who continue to exacerbate despite inhaled triple therapy, about 67% have blood eosinophil counts above 150 cells/µL, suggesting a substantial segment of patients who may be eligible for this new add-on treatment option.

GSK plc has entered into an agreement with the U.S. Administration to lower the cost of its prescription medicines for American patients, including its broad respiratory portfolio used by more than 40 million people in the U.S. with asthma and COPD. The agreement delivers on all four actions requested by President Trump in his July 31 letter, including lowering prices for certain medicines in Medicaid and launching new products with a more balanced pricing approach across developed nations.

GSK will also offer most of its inhaled respiratory portfolio and other products through a direct purchasing platform that can provide savings of up to 66% for patients. As part of the President's Strategic Active Pharmaceutical Ingredients Reserve, GSK will secure a U.S. reserve of albuterol, a key ingredient in many inhalers. The agreements cover both GSK and ViiV Healthcare, clarify the future U.S. pricing framework, and exclude them from s232 tariffs for three years. GSK reiterates its plan to invest more than $30bn in U.S. R&D and manufacturing over five years, including $2bn of new commitments that are expected to create hundreds of highly skilled U.S. jobs.

GSK plc disclosed several share purchases by board members and a person closely associated with the Non-Executive Chair. On 19 December 2025, Independent Non-Executive Director Wendy Becker bought 441 ordinary shares at £18.0909 each on the London Stock Exchange. On the same date, Independent Non-Executive Director Elizabeth (Liz) McKee Anderson bought 201 American Depositary Shares (ADSs) at $48.5550, Senior Independent Non-Executive Director Charles Bancroft bought 1,577 ADSs at $48.5550, and Independent Non-Executive Directors Dr Anne Beal, Dr Hal Dietz and Dr Jeannie Lee purchased 201, 201 and 202 ADSs respectively at $48.5550 on the New York Stock Exchange. Dr Vishal Sikka acquired 730 ADSs at $48.5550 on the same date. On 22 December 2025, Lady Susan Symonds, a person closely associated with the Non-Executive Chair, purchased 1,650 ordinary shares at £18.1046 on the London Stock Exchange.

GSK plc reports that, acting through BNP Paribas SA, it repurchased 232,912 of its ordinary shares on 19 December 2025 as part of its existing share buyback programme. The shares were bought at prices between 1,798.50p and 1,818.00p, with a volume-weighted average price of 1,807.58p, and will be held as treasury shares.

Since 30 September 2025, GSK has repurchased 14,554,645 ordinary shares under this programme. After the latest transactions, the company holds 240,019,489 shares in treasury and has 4,075,425,537 ordinary shares in issue, which is also the total number of voting rights. GSK states that, in line with regulatory rules, 5.89% of its voting rights are now attributable to shares held in treasury.