GSK’s clinical data for depemokimab positions the asset for potential FDA approval in asthma and chronic rhinosinusitis, according to reporting by the Insights Investigative News team at GlobalData, a leading data and analytics company.

Depemokimab acts by targeting interleukin-5 (IL-5) to reduce eosinophil-driven inflammation and is administered as a twice-yearly subcutaneous injection. The asset has been assessed in the pivotal Phase III SWIFT-1 and SWIFT-2 asthma trials, alongside the ANCHOR-1 and ANCHOR-2 studies in chronic rhinosinusitis with nasal polyps (CRSwNP), with results showing efficacy and safety consistent with FDA approval requirements.

Depemokimab’s Prescription Drug User Fee Act (PDUFA) decision date for asthma and CRSwNP is set for December 16, 2025. The Phase III data for depemokimab support the likely FDA approval in both indications; however, its success could hinge on its twice-yearly dosing convenience.

Irena Maragkou, Senior Healthcare Researcher at GlobalData, comments: “Experts say that depemokimab’s efficacy is broadly comparable to existing biologics and does not exceed competitors such as Dupixent. However, its ultra-long dosing schedule represents a significant differentiator in a highly competitive market.”

GlobalData’s consensus forecasts project depemokimab’s global sales to reach $1.65 billion by 2031. A detailed analysis of the publicly available data on depemokimab, its upcoming approval decision date, and expert insights on other material events is included in the “Catalyst Monitor Q4 2025” report, which covers a total of 20 significant events that are expected to occur in Q4 2025.

Some of the catalysts covered in the report, include FDA approval decisions for Cytokinetics’ aficamten in hypertrophic cardiomyopathy (HCM) and Aldeyra Therapeutics’ reproxalap in keratoconjuctivitis sicca (dry eye), Sanofi’s tolebrutinib in primary progressive multiple sclerosis (PPMS), and more.

Cytokinetics’s aficamten’s PDUFA is set for December 26, 2025. The asset shows strong potential for HCM, supported by efficacy data and quality-of-life benefits. Aficamten’s high cost may push some patients toward cheaper beta blockers or calcium channel blockers.

Maragkou adds: “However the future of HCM treatment may involve a combination approach, such as integrating myosin inhibitors, myosin modulators, and SGLT1/2 inhibitors to optimize patient outcomes.”

The report also includes journalist coverage of other catalysts like Edgewise Therapeutics’ sevasemten for Duchenne muscular dystrophy, Pfizer’s brentuximab vedotin for diffuse large B-cell lymphoma, amongst others.

The Catalyst Monitor report is published on a quarterly basis. The data presented in this report reflects the database as of September 30, 2025.