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GSK advances mRNA flu shot after Phase II success. 1,871.00p. 14:02 01/09/26. Drugmaker GSK said on Tuesday that it will move its mRNA seasonal flu vaccine candidate into Phase III after reporting positive Phase II results at the OPTIONS XIII influenza conference. 10,770.55. 5,869.38. 5,805.44. 23,612.26. 14:01 01/09/26. GSK said the candidate generated higher immune responses across all tested strains than both standard-dose and high-dose inactivated flu vaccines in younger and older adults, and was generally well tolerated. The Phase III study, due to begin in September, will be the first late-stage trial of an mRNA flu vaccine designed to target both haemagglutinin (HA) and neuraminidase (NA) - the two key surface antigens that help the virus bind and spread. Licensed flu vaccines primarily target HA, but GSK said growing evidence suggests adding NA could improve protection, reduce illness severity and help curb transmission. Sanjay Gurunathan, GSK's head of vaccines and infectious diseases R&D, said: "These promising data support the potential to better protect people from flu with a vaccine designed to target both HA and NA. With one billion flu cases worldwide each year and up to 650,000 deaths there is a need for next generation vaccine approaches. This result is a significant advance in our cutting-edge mRNA programme, and we look forward to starting phase III imminently." As of 1100 BST, GSK shares were down 0.27% at 1,848.50p. Reporting by Iain Gilbert at Sharecast.com

GSK's mRNA flu vaccine Phase 3 trial tests two targets. Healthcare Commercial Intelligence September 01, 2026 Highlights. * GSK is preparing to begin a Phase 3 clinical trial of its experimental messenger RNA vaccine for seasonal influenza. * Phase 2 results showed higher immune responses against all influenza strains compared with currently available vaccines. * The vaccine candidate is designed to target both hemagglutinin and neuraminidase, and GSK has selected the optimized B-strain HA candidate for Phase 3 testing. With respiratory virus season approaching, GSK is preparing to begin a Phase 3 clinical trial evaluating its experimental messenger RNA vaccine for seasonal influenza. The company disclosed the plan after reporting Phase 2 results that showed higher immune responses against all influenza strains compared with currently available vaccines. Those results in younger and older adults were presented Tuesday at the OPTIONS XIII Conference for the Control of Influenza in Washington, D.C. GSK said currently available flu vaccines spark an immune response to hemagglutinin, or HA, a protein on the surface of the pathogen that helps it bind to a cell. The company said growing evidence suggests targeting both HA and neuraminidase, or NA, could improve protection, illness severity, and virus transmission. GSK's seasonal vaccine is a multivalent candidate that addresses both proteins. The company also said previous studies highlighted the need to improve the ability to prompt an immune response to HA protein from the influenza B strain. The Phase 2 test in 971 adults assessed two similar mRNA vaccines. FLUm3HA.b-3NA was designed to encode an optimized B-strain HA, while FLUm3HA-3NA encodes non-optimized B/HA. GSK said both vaccines demonstrated robust immune responses to HA and NA from influenza A and B strains in younger and older adults. The company described the side effect profile and safety as acceptable and selected the optimized B-strain HA vaccine candidate for Phase 3 testing, which is expected to begin later this month. Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said in a prepared statement that the data support the potential to better protect people from flu with a vaccine designed to target both HA and NA. GSK also said the first mRNA vaccine for seasonal flu is moving toward the market after the FDA's August approval of Moderna's mFLUSIVA, which addresses only the HA protein. GSK acquired its mRNA vaccine candidates from CureVac in 2024 for €400 million, or about $431.4 million, up front. company spotlight Osirium. In the current world of outsourcing, it can be hard to see who has privileged access to what on your systems. These days, the lowest paid people have the highest privileges - and they may not even work for your organisation. Osirium readdresses this balance for end-user organisations and uniquely allows MSSPs to manage tens of thousands of account credentials, outsource safely and keep their clients happy on the compliance front. more top stories September 02, 2026 * Teva said its experimental drug prevented intestinal damage in patients with celiac disease in a mid-stage clinical trial. * The Phase 2a study also showed lower gastrointestinal symptom scores and found the drug was safe and well tolerated. * Teva plans a multiple-dose Phase 2 study to define the dose and regimen for a Phase 3 test. An experimental Teva Pharmaceutical Industries drug prevented intestinal damage in patients with celiac disease, meeting the main goal of a mid-stage clinical trial in the autoimmune disease of the gut that has no FDA-approved therapies. The preliminary Phase 2a results reported Wednesday for TEV-53408, also called TEV 408, showed lower gastrointestinal symptom scores compared with a placebo. Teva said the study drug has been safe and well tolerated so far, and that more data will be presented at a future scientific meeting. The placebo-controlled study enrolled 50 adults with celiac disease who were on a gluten-free diet and had minimal intestinal damage at baseline. Two weeks after a single dose of the study drug, patients began a six-week daily gluten challenge. Researchers assessed the state of the intestines with biopsy measures and patient-reported symptoms. At the end of week 8, Teva said the results showed statistically significant and clinically meaningful prevention of gluten-induced intestinal damage compared with a placebo. TEV-53408 is a monoclonal antibody designed to block interleukin-15, a signaling protein involved in immune-mediated pathways, including inflammation and intestinal damage linked to celiac disease. Teva said patients in the study will continue to be followed through week 80 to assess durability and safety. The company also said it will proceed to a multiple-dose Phase 2 study to define the dose and regimen for a Phase 3 test, supported by an agreement with Royalty Pharma earlier this year. September 02, 2026 * Thyme Care secured more than $125 million in Series E financing and said its valuation is now over $2 billion. * The company announced a new parent entity, Thyme Companies, to build a portfolio of independent oncology businesses. * The funding will support Thyme Care's value-based care business and the growth of Thyme Companies. Thyme Care announced Wednesday that it secured more than $125 million in Series E financing, lifting its valuation to over $2 billion. The oncology company also said it has created a new parent company aimed at building a portfolio of businesses that address different parts of the oncology space. Based in Nashville, Tennessee, Thyme Care was founded in 2020 and works with health plans, employers and risk-bearing providers to support patients with cancer. The company provides care navigation services, technology and data insights, and therapeutic interventions. It helps patients understand their diagnosis, find a cancer doctor and receive clinical care between appointments. Patients also have access to a team of providers, nurses and resource specialists. The company said its services are available to 10.5 million people across all 50 states. The Series E round was led by Morgan Health and included participation from Humana, CVS Health Ventures, AlleyCorp, HealthQuest Capital, Foresite Capital, Concord Health Partners, Frist Cressey Ventures, Town Hall Ventures and a16z Bio + Health. Thyme Care said Thyme Companies will build a portfolio of independent oncology businesses focused on accelerating adoption of lower-cost biosimilars and increasing clinical trial enrollment. The first business is expected to launch later this year. Robin Shah will become executive chairman of Thyme Companies, while Thyme Care will continue under CEO Dr. Brad Diephuis, with Co-Founder Dr. Bobby Green serving as president and chief medical officer. Diephuis said the funding will drive Thyme Care's value-based care business while supporting the growth of Thyme Companies. He also said the company's core business is profitable and growing, and that the capital will allow it to scale and expand further into the commercial market and more parts of the oncology care process.

GSK Capital B.V., the Dutch financing arm of pharmaceutical company GSK plc, has priced a €3.5 billion four-tranche bond offering. The issuance includes an €850 million floating-rate note due 2028, priced at three-month Euribor plus 30 basis points. The offering also comprises a €1 billion four-year fixed-rate tranche due 2030 with a 3.50% coupon, €850 million of eight-year notes due 2034 carrying a 3.875% coupon, and €800 million of 11-year notes due 2037 with a 4.125% coupon. Settlement is scheduled for 7 September 2026. BNP Paribas and BofA Securities acted as global coordinators, whilst BNP Paribas, BofA Securities, HSBC, Santander and Standard Chartered Bank served as active bookrunners.