Wednesday, GSK Plc GSK reported fourth-quarter sales of $10.40 billion (8.12 billion Sterling Pounds), up 1% year-over-year and up 4% on constant currency. The analysts estimated sales of $9.58 billion.Vaccine sales fell 14% (-11% at constant currency) to 2.21 billion pounds, primarily impacted by lower demand for Arexvy related to a more limited ACIP recommendation in the U.S. and channel inventory consumption compared to launch year stocking in 2023. Arexvy sales reached 158 million pounds, down 70%.Menin ...

Core Viewpoint - GSK has announced that the European Medicines Agency (EMA) has accepted its regulatory filing for the IL-5 inhibitor depemokimab, targeting asthma with type II inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP) [1][2]. Group 1: Regulatory Filings and Approvals - The submission for asthma is aimed at individuals aged 12 and older, while the CRSwNP submission targets adults [2]. - Similar regulatory filings have been validated for review in China and Japan [2]. - If approved, depemokimab will be the first ultra-long-acting biologic requiring only one dose every six months [2]. Group 2: Clinical Data and Efficacy - GSK's regulatory filings are backed by positive data from late-stage programs SWIFT and ANCHOR [5]. - The SWIFT studies met co-primary endpoints, showing a statistically significant reduction in nasal polyp size and nasal obstruction compared to placebo at 52 weeks [5]. - The ANCHOR studies also met primary endpoints, demonstrating significant reductions in asthma exacerbations over 52 weeks compared to placebo [6]. Group 3: Mechanism and Additional Indications - Depemokimab targets IL-5, a key protein in type II inflammation, which affects patients with difficult-to-treat asthma and is present in up to 80% of CRSwNP patients [7]. - The drug is also being evaluated in late-stage studies for other IL-5-mediated diseases, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES) [8]. Group 4: Competitive Landscape - If approved, depemokimab will face competition from Sanofi and Regeneron's Dupixent, which is already approved for multiple type II inflammatory diseases [9]. - Dupixent's label was recently expanded by the FDA to include adolescent patients aged 12 to 17 for CRSwNP [10]. - GSK's drug may also compete with AstraZeneca's Fasenra, which is approved for eosinophilic asthma and EGPA, and is being evaluated for COPD and HES [10]. Group 5: Stock Performance - GSK shares have declined by 10% over the past year, compared to an 11% decline in the industry [3].

GSK plc (GSK) announced that the European Commission has granted approval for the expanded use of Jemperli (dostarlimab) plus chemotherapy to include all adult patients with primary, advanced or recurrent endometrial cancer.The regulatory body has now approved Jemperli in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary, advanced or recurrent endometrial cancer who are candidates for systemic therapy in the European Union (“EU”).The approval ...

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Key Points Company and Industry Overview 1. **GSK as a Global Biopharma Company**: GSK is a global biopharma company focused on the prevention and treatment of disease [3]. 2. **Demerger and Biopharma Focus**: GSK demerged its consumer business three years ago, creating a dedicated biopharma company with a clear focus on benefiting patients and shareholders [2]. Financial Performance 3. **2024 Sales and Profit Growth**: In the first nine months of 2024, GSK delivered 9% sales growth and 19% core operating profit growth [3]. 4. **Full-Year 2024 Guidance**: GSK confirmed its guidance for full-year 2024, expecting sales growth of 7% to 9% and core operating profit growth of 11% to 13% [5]. Product Approvals and Outlook 5. **Product Approvals and Growth Outlook**: GSK expects to secure five product approvals in the coming year and remains highly confident in delivering the growth outlooks set for 2026 and 2031 [5].

Company Overview - GSK is a global biopharma company focused on the prevention and treatment of disease [5] - The company demerged its consumer business three years ago to create a dedicated biopharma company with a clear focus on benefiting patients and shareholders [3] Financial Performance - For the full year 2024, GSK confirmed sales growth guidance of 7% to 9% and core operating profit growth of 11% to 13% [2] - In the first nine months of 2024, GSK delivered 9% sales growth and 19% core operating profit growth, reflecting strong momentum in Specialty Medicines and overall portfolio resilience [5] Strategic Outlook - GSK expects to secure five product approvals in 2025 [2] - The company has high confidence in delivering the growth outlooks set for 2026 and 2031 [2]

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 ...