GSK PLC SEC Filings

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, through GlaxoSmithKline LLC and Harmony Row Acquisition Co., has completed its cash tender offer for all Class A and Class B shares of Nuvalent, Inc. at $124.00 per Share, net to sellers in cash, without interest and subject to applicable withholding taxes.

As of one minute following 11:59 p.m. Eastern Time on July 14, 2026, 72,518,967 Shares (67,083,713 Class A and 5,435,254 Class B) had been validly tendered and not withdrawn, representing about 91.3% of issued and outstanding shares, including 90.7% of Class A and 100.0% of Class B. The Minimum Tender Condition and all other offer conditions were satisfied, and all such shares have been irrevocably accepted for payment.

Because Purchaser now holds more than the percentage of shares required to adopt the Merger Agreement, GSK plans to effect a Section 251(h) merger as soon as practicable without a stockholder meeting. After the merger, Nuvalent shares will be delisted from Nasdaq and their registration under the Exchange Act will be terminated.

GSK plc reports multiple acquisitions of ordinary shares and American Depositary Shares by senior management and persons closely associated, through reinvestment of dividends paid on 9 July 2026. Named participants include the chief executive officer, chief financial officer, several business presidents and other senior officers.

The acquisitions and increases in notional interests took place on 9, 10 and 13 July 2026 on the London Stock Exchange and New York Stock Exchange at prices around £19.6297 and £19.5950 per ordinary share and $52.4700 per ADS, including holdings within ISAs and positions in the company’s Deferred Annual Bonus Plan.

GSK plc reports multiple acquisitions of its ordinary shares of 31 ¼ pence each (ISIN GB00BN7SWP63) by senior management and persons closely associated with them. These transactions occurred on 9 July 2026 on the London Stock Exchange at prices around £19.6290 per share.

Lynn Baxter (President, Europe), Julie Brown (Chief Financial Officer), James Ford (SVP and Group General Counsel), David Redfern (President, Corporate Development), Regis Simard (President, Global Supply Chain), Philip Thomson (President, Global Affairs), Deborah Waterhouse (CEO, ViiV Healthcare and President, Global Health), Victoria Whyte (SVP & Company Secretary), and PCA Neil Falkingham each acquired small share amounts under GSK’s Share Reward Plan, typically 12–14 shares per person combining partnership and matching shares.

In addition, Luke Miels (Chief Executive Officer) and several of the same executives and PCAs acquired further ordinary shares through the re-investment of dividends paid on 9 July 2026 on holdings within the Share Reward Plan, with individual acquisitions ranging from a few shares to over 1,000 shares in a single transaction.

GSK plc reports positive interim data from the registrational phase II AZUR-1 trial of Jemperli (dostarlimab) in stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. The single-arm study met its primary objective, showing a meaningful, sustained clinical complete response at 12 months (cCR12), with participants having no detectable signs of cancer one year or more after treatment.

The results suggest that dostarlimab monotherapy could eliminate or delay the need for chemotherapy, radiation and surgery for some patients in this population, where current standard treatments often cause long-term quality-of-life issues. AZUR-1 enrolled 154 participants, each receiving nine cycles of 500 mg intravenous dostarlimab every three weeks over six months. The safety profile in this setting was consistent with the established, manageable profile across solid tumours.

Dostarlimab has Breakthrough Therapy and Fast Track designations from the FDA in this indication. GSK plans to share AZUR-1 interim data with global regulators, seeking review, including accelerated pathways, and will present detailed results at a future scientific congress. Jemperli is not currently approved for rectal cancer.

Nuvalent, Inc. is the subject of a cash tender offer by Harmony Row Acquisition Co., GlaxoSmithKline LLC and GSK plc to purchase all issued and outstanding Class A and Class B shares for $124.00 per Share, net to the seller in cash. The HSR waiting period expired effective July 9, 2026 at 11:59 P.M. Eastern Time, and the HSR condition to the Offer has been satisfied.

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.