GSK PLC SEC Filings

GSK reports that the US FDA has approved Utebzi (tebipenem pivoxil), the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections (cUTIs), including pyelonephritis, who have limited or no alternative oral options.

The approval is based on the phase III PIVOT-PO trial, where oral tebipenem pivoxil 600 mg achieved a 58.5% overall success rate versus 60.2% for intravenous imipenem-cilastatin 500 mg, meeting the preset non-inferiority margin. Safety was generally similar to comparator carbapenems, with mostly mild to moderate diarrhoea and headache.

cUTIs account for more than 3 million cases annually in the US and over $6 billion in healthcare costs, with treatment failure affecting up to 34% of patients. Tebipenem pivoxil is anticipated to be available to US patients by the end of 2026 and extends GSK’s anti-infectives portfolio under its collaboration with Spero Therapeutics.

GSK plc reports further share repurchases under its existing buyback programme. Between 8 and 12 June 2026, the company, via Citigroup Global Markets Limited, bought a series of ordinary shares of 31¼ pence each on UK exchanges at prices around the high-1,800 to low-2,000 GBp range.

The purchased shares will be held as Treasury shares. Since 11 May 2026, GSK has bought a total of 7,346,236 ordinary shares. After the latest purchases, GSK holds 268,724,522 ordinary shares in treasury and has 4,047,527,077 ordinary shares in issue excluding treasury.

The total number of voting rights is now 4,047,527,077, and GSK states that 6.64 per cent of voting rights are attributable to treasury shares, which investors can use when assessing disclosure thresholds under UK transparency rules.

GSK plc reports that its JAK inhibitor momelotinib has received Orphan Drug Designation from both the US FDA and the EMA for treating VEXAS syndrome, a rare and life-threatening haemato-inflammatory disorder with no approved therapies.

The decision draws on case studies suggesting JAK inhibitors, including momelotinib, may help reduce VEXAS-related symptoms, inflammation and blood complications. A planned phase II/III ATLAS trial will evaluate momelotinib’s efficacy and safety in VEXAS and is intended to support global regulatory submissions as part of a broader haematology development programme.

Momelotinib (Ojjaara/Omjjara) is already approved in the US, EU, UK and Japan for various myelofibrosis indications in adults with anaemia or disease-related symptoms, and has a differentiated mechanism targeting JAK1, JAK2 and ACVR1 signalling pathways.

GSK plc reports that several senior leaders and one person closely associated with a leader acquired small amounts of company stock through its Share Reward Plan. On 2026-06-09, each transaction involved GSK ordinary shares of 31 ¼ pence each, traded on the London Stock Exchange.

Executives including President Europe Lynn Baxter, Chief Financial Officer Julie Brown, and other senior leaders acquired either 14 or 12 ordinary shares each at a price of £18.8393 per share, split between partnership and matching shares. These are routine share plan acquisitions rather than open-market trades.

GSK plc, together with GlaxoSmithKline LLC and acquisition subsidiaries, announced a planned cash tender offer to acquire all issued and outstanding Class A and Class B shares of Nuvalent, Inc. The parties referenced an Agreement and Plan of Merger dated June 9, 2026. The announcement is a pre-commencement communication and the tender offer has not yet commenced. The filing states that when the offer is launched GSK plc, Parent and Purchaser will file a Tender Offer Statement on Schedule TO and Nuvalent will file a Solicitation/Recommendation Statement on Schedule 14D-9. The documents will be made available free on the SEC website and on the companies' investor sites. The communication contains forward-looking statements and directs readers to the "Risk Factors" in GSK plc's Annual Report on Form 20-F for the year ended December 31, 2025.

GSK plc reported that Maya Martinez-Davis, President, acquired notional American Depositary Shares through her GSK Executive Supplemental Savings Plan account. The transaction involved 9.4289 ADS at a price of $50.6400 per ADS on 2026-06-08, executed on the New York Stock Exchange.

GSK plc announced a planned cash tender offer to acquire all issued and outstanding Class A and Class B common shares of Nuvalent, Inc. The parties entered into an Agreement and Plan of Merger dated June 9, 2026. The tender offer has not commenced; when it does, the offerors will file a Tender Offer Statement on Schedule TO and the company will file a Solicitation/Recommendation Statement on Schedule 14D-9. Tender offer materials will be made available to Nuvalent stockholders and posted on the SEC website and the parties' investor websites.

GSK plc reported a change in the outside roles of one of its board members. Dr Hal Barron, a Non-Executive Director at GSK, was appointed an Independent Director and Chair of the Nominating and Corporate Governance Committee of Quantinuum Inc. on 4 June 2026.

The company notes this appointment in line with UK Listing Rule 6.4.9R(2). GSK remains a global biopharma company focused on uniting science, technology and talent to get ahead of disease.

GSK plc has announced a planned cash tender offer to acquire all issued and outstanding Class A and Class B common stock of Nuvalent, Inc. The announcement references an Agreement and Plan of Merger dated June 9, 2026 between GlaxoSmithKline LLC, Harmony Row Acquisition Co. and Nuvalent.

The communication is a pre-commencement Schedule TO filing and states the tender offer has not yet commenced. When the offer is launched, GSK plc, Parent and Purchaser will file a Tender Offer Statement on Schedule TO and Nuvalent will file a Solicitation/Recommendation Statement on Schedule 14D-9.