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Biotech Stocks Facing FDA Decision In December 2025

GSK
GSK

GSK Plc’s (GSK) Biologics License Application for the use of Depemokimab in two indications are under review by the FDA, with a decision due on December 16, 2025.

The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

Depemokimab is a monoclonal antibody that targets IL-5, a key cytokine (protein) in type 2 inflammation. This type of inflammation is common in people with hard-to-control asthma and can cause flare-ups and hospital stays. It also affects up to 85% of people with chronic sinusitis with nasal polyps (CRSwNP) and is associated with more severe disease and symptoms.

If approved, Depemokimab’s global sales are expected to reach $1.65 billion by 2031, according to GlobalData’s consensus forecast.

GSK closed Wednesday’s (November 26, 2025) trading at $48.02, up 0.99%.