GSK PLC SEC Filings

GSK plc reported that Europe’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of depemokimab for two uses: severe asthma with type 2 inflammation and severe chronic rhinosinusitis with nasal polyps (CRSwNP). If approved, depemokimab would be the first ultra-long-acting biologic for respiratory disease in the EU, given as just two doses a year. The opinion is based on four phase III trials showing a 54% reduction in clinically significant asthma exacerbations over 52 weeks and a 72% reduction in exacerbations requiring hospital or emergency department care, versus placebo plus standard treatment. In CRSwNP, depemokimab improved nasal polyp size and nasal obstruction scores. The European Commission decision is expected in Q1 2026, and depemokimab is not yet approved anywhere.

GSK plc reported that the European Medicines Agency’s CHMP has issued a positive opinion recommending approval of Nucala (mepolizumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils who are already on inhaled triple therapy. The opinion is based on the phase III MATINEE trial, where Nucala reduced the annual rate of moderate or severe COPD exacerbations versus placebo when both were added to triple therapy, with a rate ratio of 0.79 and similar overall adverse event rates between groups.

A pre-defined secondary analysis showed Nucala also lowered exacerbations that led to emergency department visits and/or hospitalisations compared with placebo. Nucala is already approved in Europe for four eosinophilic and type 2 inflammatory conditions and received US approval for COPD in May 2025. The European Commission decision on this new COPD indication is expected in Q1 2026, which could expand treatment options for patients whose disease remains uncontrolled.

GSK plc reports that the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion to expand the indication of its RSV vaccine Arexvy to all adults aged 18 years and older. A final decision from the European Commission is expected in February 2026, which, if approved, would allow use across the full adult population.

Arexvy is already approved in Europe for preventing lower respiratory tract disease caused by RSV in adults 60 and older, and in adults 50–59 at increased risk. RSV is described as a common respiratory virus that can cause severe disease, with an estimated 64 million people affected globally every year and around 158,000 adults aged 18 and over hospitalised annually in the EU. GSK is also pursuing expanded indications in other regions, including the US and Japan.

GSK plc reports that it repurchased 217,000 ordinary shares on 11 December 2025 through BNP Paribas SA as part of its existing share buyback programme. The shares, bought at prices between 1,793.00p and 1,820.00p with a volume‑weighted average price of 1,807.53p, will be held in treasury. Since 30 September 2025, the company has bought 13,161,733 ordinary shares under this programme. After this latest transaction, GSK holds 238,626,577 shares in treasury and has 4,076,812,560 ordinary shares in issue, which is also the total number of voting rights. The company states that treasury shares now represent 5.85% of its voting rights.

GSK plc announced that the US FDA has approved a supplemental New Drug Application for Blujepa (gepotidacin) as an oral treatment option for uncomplicated urogenital gonorrhoea in adults and adolescents from 12 years of age who weigh at least 45 kg and have limited or no alternative options. This makes Blujepa the first drug from a new antibiotic class approved for gonorrhoea in more than three decades and offers an oral alternative to current injectable standard-of-care regimens.

The decision is based on the phase III EAGLE-1 trial, which showed gepotidacin was non-inferior to a combination of intramuscular ceftriaxone and oral azithromycin, with no serious drug-related adverse events and mainly mild to moderate gastrointestinal side effects. The approval builds on an earlier US authorization of gepotidacin for uncomplicated urinary tract infections, strengthening GSK’s infectious disease portfolio in an area of growing antimicrobial resistance.

GSK plc reported a series of small share acquisitions by senior executives under the company’s Share Reward Plan. On 9 December 2025, Chief Executive Officer Emma Walmsley, Chief Financial Officer Julie Brown and several other senior leaders, including the group general counsel, heads of global communications, corporate development, global supply chain, global affairs, ViiV Healthcare and the company secretary, each acquired GSK ordinary shares of 31¼ pence. The purchases combined partnership and matching shares, with individual totals ranging from 12 to 14 ordinary shares at a price of £18.0780 per share. All transactions took place on the London Stock Exchange (XLON) and are routine disclosures of dealings by persons discharging managerial responsibilities.

GSK plc has applied to list 250,000 new Ordinary Shares of 31¼p each on the Financial Conduct Authority’s Official List and to trade them on the London Stock Exchange. These shares are being reserved under a block listing for the GlaxoSmithKline plc Share Save Plan 2022, a plan that allows eligible employees to acquire shares in the company.

Admission of these shares is expected to become effective on 12 December 2025. Once issued, the new shares will rank equally with all existing GSK Ordinary Shares, meaning they will carry the same rights to dividends and voting as the current share capital.

GSK plc reports that on 10 December 2025 it repurchased 220,000 ordinary shares of 31¼ pence each under its existing share buyback programme, acting through BNP Paribas SA. The shares were bought at prices between 1,771.00p and 1,807.00p per share, with a volume-weighted average price of 1,789.73p.

The repurchased shares will be held as treasury shares. Since 30 September 2025, GSK has bought a total of 12,944,733 ordinary shares under this programme. After this transaction, GSK holds 238,409,577 shares in treasury and has 4,077,029,560 ordinary shares in issue, which is also the total number of voting rights in the company. GSK states that treasury shares now represent 5.85% of its voting rights.

GSK plc reports that it repurchased 250,000 of its ordinary shares on 9 December 2025 through BNP Paribas SA under its existing share buyback programme. The shares, with a nominal value of 31¼ pence each, were bought at prices between 1,780.00p and 1,820.00p, at a volume‑weighted average price of 1,800.43p, and will be held as treasury shares.

Since 30 September 2025, GSK has purchased a total of 12,724,733 ordinary shares under this programme. After the latest transactions, the company holds 238,189,577 shares in treasury and has 4,077,249,560 ordinary shares in issue, which also represents the total number of voting rights. GSK states that, in line with regulatory rules, treasury shares now account for 5.84 per cent of the company’s voting rights, a figure shareholders can use when calculating disclosure thresholds.