TLDRs:
- GSK stock rises after Japan approves twice-yearly Exdensur asthma treatment.
- China clears Nucala for COPD, expanding GSK’s respiratory therapy portfolio.
- Clinical trials show Exdensur reduces asthma attacks and nasal polyp severity.
- European approval pending, execution risks could impact Exdensur’s commercial success.
GSK plc saw its shares rise by nearly 1% in early trading on Tuesday after Japan’s health authorities approved the company’s bronchial asthma treatment, Exdensur.
By 0830 GMT, the stock was trading at 1,838 pence, reflecting investor optimism around the new respiratory therapy. Market watchers noted that the approval could mark an important step in expanding GSK’s presence in the inflammatory airway disease market, a core area of growth for the company.
Exdensur, also known as depemokimab, is designed for twice-yearly administration, offering patients a more convenient treatment option compared with existing biologics that require more frequent dosing. Analysts highlight that while Exdensur enters a crowded market, its dosing schedule could drive adoption if patients and healthcare providers embrace the convenience factor.
China Approval Adds Momentum
GSK’s regulatory momentum extends beyond Japan. On Monday, Chinese authorities approved Nucala (mepolizumab) as an add-on maintenance therapy for adults with chronic obstructive pulmonary disease (COPD) who have inadequately controlled symptoms. The approval targets patients with elevated blood eosinophils, a white blood cell associated with airway inflammation.
Clinical studies such as the MATINEE and METREX phase III trials demonstrated that Nucala reduced moderate to severe COPD flare-ups, signaling meaningful benefits for patients struggling with chronic lung conditions.
The back-to-back approvals in Asia underscore GSK’s strategy to broaden its respiratory portfolio, combining both asthma and COPD treatments under its inflammatory airway disease focus. Investors are watching closely to see if this momentum translates into meaningful market share growth across regions.
Exdensur’s Clinical Impact
Clinical data has been a cornerstone of Exdensur’s approval. In the SWIFT studies, patients receiving the drug experienced a 58% reduction in annualised asthma attacks compared with placebo, while ANCHOR trials reported measurable improvements in nasal polyp outcomes.
GSK’s global head of Respiratory, Immunology & Inflammation R&D, Kaivan Khavandi, noted that the approval “could set a new standard of care,” highlighting the drug’s potential to influence treatment protocols for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
Despite the strong trial results, analysts caution that Exdensur’s real-world success will depend on reimbursement decisions, physician adoption, and competition from established biologics like Dupixent and Xolair.
Regulatory Path Ahead
Looking forward, GSK is preparing for regulatory reviews in Europe, with a European Commission decision on Exdensur anticipated in the first quarter of 2026 following a positive opinion from the European Medicines Agency’s CHMP panel. Market experts note that execution risks, including pricing, prescriber caution, and competitor strategies, will ultimately determine the commercial impact of the approvals. Even with strong clinical data, slower uptake or aggressive discounting could temper revenue growth from these launches.
Overall, GSK’s recent approvals in Japan and China position the company to solidify its standing in the respiratory therapy market. Investors appear cautiously optimistic, valuing both the immediate stock bump and the potential long-term growth from a diversified airway disease portfolio.
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