Regulation

GSK Gains EU Approval for Nucala in COPD, Stock Momentum in Focus

GSK shares rose after EU regulators approved expanded use of Nucala for chronic obstructive pulmonary disease. The stock has surged 17% this week and nearly 49% over the past year.

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GSK Gains EU Approval for Nucala in COPD, Stock Momentum in Focus
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GSK plc shares closed Friday's session higher, advancing 0.8% to 2,198 pence, following regulatory approval from the European Commission for an expanded label for its respiratory drug Nucala.

The authorization allows Nucala (mepolizumab) to be used as an add-on treatment for adults with uncontrolled COPD who have elevated blood eosinophils, even after using standard triple inhaler therapy. This marks the first monthly biologic option for this patient group in the EU.

Clinical data from the MATINEE phase 3 trial supported the decision, showing Nucala reduced the annual rate of moderate or severe exacerbations by 21% versus placebo. It also cut exacerbations leading to emergency room visits or hospitalizations by 35%.

Investor sentiment has been bolstered by recent insider buying. Chairman Jonathan Symonds purchased 2,500 shares earlier this week at an average price of £21.14 per share, a transaction valued at approximately £52,850.

Despite the positive regulatory news, some analysts remain cautious. JP Morgan maintains a Sell rating on GSK with a price target of 1,700 pence, roughly 23% below Friday's closing level.

Attention now turns to the commercial rollout and whether the new indication can meaningfully impact 2026 financial forecasts. The company's stock will trade ex-dividend on February 19 for its upcoming quarterly distribution, with the payment scheduled for April 9.