GSK plc SEC Filings

GSK plc reports that the US Food and Drug Administration has approved Jideytro (zidesamtinib), a ROS1 selective kinase inhibitor, for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor. The decision comes ahead of the original target action date of 18 September 2026 and follows Breakthrough Therapy and Orphan Drug Designations.

The approval is based on the global single-arm ARROS-1 phase I/II trial in previously ROS1 inhibitor-treated patients, where among 117 patients the objective response rate was 44% and duration of response rates were 82% at six months and 69% at 12 months. A pooled safety population of 446 patients showed common adverse reactions including oedema, peripheral neuropathy, constipation, fatigue and dyspnoea.

Jideytro is GSK’s first approved lung cancer medicine and originates from the recently completed acquisition of Nuvalent, Inc. GSK also highlights additional targeted oncology programmes, including neladalkib (NVL-655) for ALK-altered NSCLC with a US FDA target decision date of 27 November 2026, NVL-330 for HER2-altered NSCLC, and the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan (Ris-Rez) in late-stage development.

GSK reports that the European Medicines Agency has accepted a submission to update the label for Bexsero to include a single-dose booster for individuals aged 10 years and older who were previously vaccinated with Bexsero. If approved, this booster could help reduce the burden of Invasive Meningococcal Disease (IMD) in countries with established infant MenB programmes.

The submission is supported by a Phase 3b, open-label, multicentre study in 10 to 20-year-olds showing one booster dose effectively boosted immune responses in those vaccinated as infants. IMD is a rare, life‑threatening disease with a fatality rate of 4–20%, and up to 20% of survivors experience severe, life-changing sequelae. In 2024, serogroup B caused 56% of IMD cases under age 65 in the EU/EEA. Bexsero is registered in 61 countries, included in multiple European immunisation programmes, and around 138 million doses have been distributed globally since 2015.

GSK plc announces that, following a competitive tender process led by its Audit & Risk Committee, the Board has decided to re-appoint Deloitte LLP as external auditor from the financial year ending 31 December 2028. Deloitte was initially appointed for the financial year ended 31 December 2018.

As a Public Interest Entity, GSK is required to tender its statutory audit every 10 years and rotate auditor every 20 years. A resolution to re-appoint Deloitte with effect from the 2028 financial year will be put to shareholders for approval at the 2028 Annual General Meeting, with further details to appear in GSK’s 2026 Annual Report.

GSK plc reported mixed Phase III results for camlipixant in adults with refractory chronic cough. In the 52-week CALM-1 study, camlipixant 50mg twice daily achieved the primary endpoint, showing statistically significant reductions in 24-hour cough frequency versus placebo at week 12.

In the 24-week CALM-2 study, the same 50mg dose did not reach statistical significance at week 24, and the 25mg twice-daily dose was not significant in either trial. Key secondary endpoints, including the Chronic Cough Diary measure, were not met. With overall safety similar to placebo but efficacy deemed unlikely to transform patient care, GSK will not progress camlipixant further in RCC, while continuing the Phase IIb BALANCE trial in irritable bowel syndrome.

GSK plc reported that several senior leaders and non-executive directors acquired small amounts of American Depositary Shares (ADS) through the automatic re-investment of cash dividends paid to shareholders on 9 July 2026. The ADSs trade on the New York Stock Exchange.

On 10 July 2026, multiple directors, including Maya Martinez-Davis and several independent non-executive directors, acquired ADSs at prices of $52.4700 and $52.7353 per ADS. On 14 July 2026, executives including James Ford, Maya Martinez-Davis and Shobie Ramakrishnan received additional ADSs at $51.6696 per ADS, all as single transactions executed on the NYSE.

GSK plc has completed its acquisition of Nuvalent, Inc., a Boston-based clinical-stage biopharmaceutical company developing precisely targeted oncology therapies. The deal adds three lung cancer assets to GSK’s portfolio, strengthening its planned expansion from blood and women’s cancers into lung and other solid tumours.

The transaction was executed via a tender offer for all of Nuvalent’s outstanding shares, with an aggregate equity value of $10.6 billion (£8.0 billion). Net of cash acquired, GSK’s aggregate investment is approximately $9.4 billion (£7.1 billion). The acquisition includes zidesamtinib (NVL-520) and neladalkib (NVL-655), both under FDA review for specific forms of non-small cell lung cancer and holding Breakthrough Therapy and Orphan Drug Designations, which GSK states are expected, if approved, to launch in 2026 with multi-blockbuster potential. It also brings NVL-330, in phase I for HER2-altered non-small cell lung cancer.

GSK plc reports that its licensor Hansoh Pharmaceutical Group achieved positive pivotal phase III results for risvutatug rezetecan (Ris-Rez) in advanced or relapsed small-cell lung cancer in a China patient population. The ARTEMIS-008 study met its primary endpoint of overall survival, showing statistically significant and clinically meaningful benefit versus topotecan, with consistent improvements in key secondary endpoints such as progression-free survival and a safety profile in line with prior data.

These data will support Hansoh Pharma's regulatory submission in China. GSK holds exclusive rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan and is running a broad programme across lung, prostate and other solid tumours, including the global phase III EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer, where pivotal data are expected next year. The company highlights this as the first positive phase III overall survival result for a B7-H3-targeted antibody-drug conjugate in any tumour type.

GSK plc reported that senior executive Maya Martinez-Davis acquired notional American Depositary Shares within her GSK Executive Supplemental Savings Plan account. The transaction involved 8.955 notional ADS at a price of $53.3200 per ADS on 7 July 2026, executed on the New York Stock Exchange.

GSK plc has appointed Roy Jakobs to its Board as an independent Non-Executive Director, effective 13 July 2026. He is currently Chief Executive Officer of Royal Philips, a global health technology company with 2025 sales of 17.8 billion EUR and 65,000 employees.

GSK’s Board determined that Jakobs meets independence criteria under the UK Corporate Governance Code. He will receive the standard annual Non-Executive Director fee of £122,258 and is required to build a holding of GSK shares equal to two times this fee, in line with the shareholder-approved Non-Executive Director remuneration policy.