UK approves GSK’s twice-yearly asthma biologic Exdensur

The UK regulator (MHRA) cleared $GSK’s Exdensur as a twice-yearly, under-the-skin injection for asthma (add-on therapy for patients 12+ still uncontrolled on standard treatment) and for adults with chronic rhinosinusitis with nasal polyps. It targets IL-5 to reduce eosinophil-driven inflammation, a key driver of severe asthma flares. This is the first approval globally, with a U.S. FDA decision expected on 16 Dec 2025.

Winners

Category 1: Sponsor and respiratory franchise upside

Reason: First approval de-risks launch timing, strengthens GSK’s respiratory growth narrative, and a twice-yearly dosing schedule can be a differentiation lever that supports uptake.

$GSK

$PFE

Category 2: Injectable delivery and packaging

Reason:  ...