GSK plc (GSK) announced that the FDA has granted a Breakthrough Therapy Designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK’227), for the treatment of relapsed or refractory osteosarcoma in adult patients whose disease progressed on at least two prior lines of therapy.The FDA grants Breakthrough Therapy designation to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that the therapy ...

GSK plc’s (GSK) HIV subsidiary, ViiV Healthcare announced that the Europe Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion recommending marketing authorization for its new long-acting HIV regimen.ViiV Healthcare is a global specialist HIV company, majorly owned by GSK with Pfizer (PFE) and Shionogi as shareholders.ViiV Healthcare was formed by GSK and Pfizer in 2009.The CHMP recommended marketing authorization to Vocabria (cabotegravir long-a ...

GSK plc (GSK) announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma (RRMM) for review.The BLA seeks the approval of Blenrep in combination with J&J’s Velcade (bortezomib) plus dexamethasone (BorDex) or Bristol Myers’ Pomalyst (pomalidomide) plus dexamethasone (PomDex) for the treatment of patients with multiple myeloma who have received at least one prior line of the ...

GSK plc (GSK) announced positive headline data from the phase III GLISTEN study, which is evaluating its investigational targeted inhibitor of the ileal bile acid transporter (IBAT), linerixibat, for treating adult patients with cholestatic pruritus associated with primary biliary cholangitis (PBC).The global GLISTEN study met its primary endpoint by showing that treatment with linerixibat led to a statistically significant improvement in monthly itch score as compared with placebo over 24 weeks.Per managem ...

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President-elect Donald Trump this week nominated Robert F. Kennedy Jr. to be the next Secretary of ... [+] the U.S. Department of Health and Human Services. In this photo, the vaccine skeptic speaks during a hearing with the House Judiciary Subcommittee on the Weaponization of the Federal Government on Capitol Hill on July 20, 2023 in Washington, DC. (Photo by Anna Moneymaker/Getty Images)Getty ImagesStocks of major drug makers and biotech companies tumbled in trading late this week after President-elect Do ...

GSK plc (NYSE:GSK) Guggenheim's Inaugural Healthcare Innovation Conference November 12, 2024 2:00 PM ET Company Participants Emma Walmsley - Chief Executive Officer Conference Call Participants Seamus Fernandez - Guggenheim Seamus Fernandez I'm absolutely thrilled that this we're clearly going to have the best conversation in the fireside chat that we've had so far. Incredibly pleased to have Emma Walmsley here. She's CEO and on the Board of Directors of GlaxoSmithKline, or sorry, GSK. I have to, I can't s ...

GSK plc (GSK) reported third-quarter 2024 core earnings of $1.27 per American depositary share (ADS), which beat the Zacks Consensus Estimate of $1.16. Core earnings declined 1% year over year on a reported basis but rose 5% at a constant exchange rate (CER). Quarterly revenues fell 2% on a reported basis but rose 2% at CER to $10.42 billion (£8.01 billion). The top line missed the Zacks Consensus Estimate of $10.65 billion. This was due to lower sales of RSV and shingles vaccines in the United States. All ...

Financial Data and Key Metrics Changes - GSK reported a 9% sales growth and a 19% profit growth year-to-date, reflecting strong performance in Specialty Medicines [4][10] - Excluding COVID, sales for the quarter grew 2% and 9% year-to-date, with core operating profit and core EPS growth both up 5% [5][9] - Cash generated from operations was GBP5.3 billion year-to-date, an increase of GBP0.9 billion compared to last year [52] Business Line Data and Key Metrics Changes - Specialty Medicines, the largest segment, grew 19%, driven by strong performance in oncology and HIV [19][30] - General Medicines sales increased by 7%, primarily due to Trelegy, which saw a 16% increase [35] - Vaccine sales declined by 15%, impacted by lower demand for Arexvy and Shingrix [20][21] Market Data and Key Metrics Changes - The U.S. market was significantly impacted by lower vaccine demand, while international markets showed good growth [20] - Arexvy is now launched in 35 markets, with 16 having national recommendations [22] - Shingrix's growth outside the U.S. was 9%, with U.S. penetration at 39% [23] Company Strategy and Development Direction - GSK aims for 7% to 9% sales growth and double-digit profit growth for 2024, with a focus on Specialty Medicines and Vaccines [16][57] - The company plans to pursue bolt-on business development to enhance its pipeline and technology platforms [17] - GSK is committed to delivering sustainable health impact, particularly in its HIV business, with plans to provide long-acting treatments in low and middle-income countries [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year guidance and long-term growth outlooks, despite challenges in the vaccine segment [61][63] - The company anticipates continued growth in Specialty Medicines, particularly in oncology and respiratory treatments [30][38] - Management acknowledged potential pressures from the U.S. Inflation Reduction Act but remains optimistic about underlying demand for its products [38][94] Other Important Information - GSK has made significant progress in its pipeline, with 11 positive phase III readouts and plans for five major product launches next year [11][12] - The company reported a GBP1.8 billion charge related to the resolution of Zantac litigation, impacting operating profit [49] - GSK's net debt decreased to GBP13 billion, reflecting strong free cash generation [54] Q&A Session Summary Question: Update on pneumococcal vaccine and its timeline - Management confirmed a shift to a 30-valent vaccine for adults, with a first-in-human study expected next year [70][71] Question: Expectations for 2025 regarding Shingrix and Arexvy - Management expects 2025 to be another year of profitable growth, with continued focus on Specialty Medicines [72][74] Question: Sales contribution of Shingrix in China - GSK has sold around 240 million doses under its contract with Zhifei, with flexibility in the contract terms [90] Question: Detailed Phase III Nucala data release - Detailed data from the MATINEE trial will be presented in the first half of next year [86] Question: RSV opportunities outside the U.S. - Management indicated that the RSV vaccine is expected to see good adoption internationally, with ongoing contract negotiations [100]

Form 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of October 2024 Commission File Number 001-15170 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 GSK plc (Translation of registrant's name into English) 79 New Oxford Street, London, WC1A 1DG (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form ...