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Celldex Therapeutics’ barzolvolimab produced deep complete responses across two Phase 3 chronic spontaneous urticaria trials while maintaining efficacy in patients refractory to omalizumab. Representative image.
Features & Analysis

Barzolvolimab can eliminate hives and itch for about half of patients. What does Celldex need to prove before launch?

Celldex Therapeutics has delivered positive results from both Phase 3 EMBARQ studies of barzolvolimab in chronic spontaneous urticaria, with roughly 42% to 46% of treated patients completely free of hives and itch by Week 12 and response rates deepening through Week 24. The clinical programme also produced substantial activity after omalizumab failure and against angioedema,

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Aravax’s PVX108 peptide immunotherapy is being developed to retrain peanut-specific immune responses without using whole peanut proteins, as FDA Fast Track status sharpens attention on upcoming Phase 2 results. Representative image.
Pharma & Biotech

Aravax’s peanut allergy treatment avoids whole allergens. FDA Fast Track status puts its biggest test in focus

Aravax has secured United States Food and Drug Administration Fast Track designation for PVX108, an investigational peptide immunotherapy designed to retrain peanut-specific immune responses without containing whole peanut proteins or allergen extracts. The regulatory milestone increases the importance of Phase 2 results expected later in 2026.

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