GSK (LSE:GSK) has received approval from the European Commission for Exdensur (depemokimab), marking the first ultra-long-acting biologic authorized in the European Union for severe asthma driven by type 2 inflammation. The therapy is also cleared as an add-on treatment for severe chronic rhinosinusitis with nasal polyps. Backed by data from four Phase III studies demonstrating durable efficacy and a favorable safety profile with dosing just twice per year, the decision bolsters GSK’s respiratory portfolio and introduces a differentiated option that could reshape care standards for patients whose disease remains poorly controlled.
Clinical results underpinning the approval showed sustained symptom control and reduced exacerbations across both indications, highlighting the potential of depemokimab to address unmet needs in type 2 inflammatory disease. The extended dosing schedule may improve adherence and reduce treatment burden compared with more frequent biologic regimens. Meanwhile, the asset continues to be evaluated in additional late-stage trials, supporting potential expansion into other type 2 inflammatory conditions.
GSK’s broader investment case remains centered on solid profitability and strengthening operational performance. Management’s guidance for 2026 reflects confidence in continued momentum across key franchises, including respiratory and vaccines. Shares appear reasonably valued and offer a modest dividend yield, though technical indicators suggest overbought conditions in the near term. Investors are also monitoring balance-sheet discipline and the consistency of earnings delivery.
More about GSK
GSK is a global biopharmaceutical leader specializing in respiratory and inflammatory diseases. Its portfolio spans vaccines, targeted biologics and inhaled therapies. The company’s strategy is focused on advancing respiratory medicine by addressing underlying disease pathways and slowing progression in asthma, chronic obstructive pulmonary disease (COPD), and rare respiratory disorders.
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