Hope Beyond the Itch: Barzolvolimab Delivers "Unprecedented" Long-Term CSU Remission

Ava ChenJun 13, 2025
An artistic representation of agitated mast cells calming, leading to clear skin on a relieved individual, symbolizing the long-term freedom from CSU achieved with barzolvolimab.
  • Sustained Freedom: Up to 41% of Chronic Spontaneous Urticaria (CSU) patients achieve complete symptom remission 76 weeks post-barzolvolimab treatment, a remarkable seven months after dosing completion.
  • Life Reclaimed: Nearly half of patients (48%) report their disease no longer significantly impacts their quality of life long-term.
  • Targeted Power: Barzolvolimab directly addresses mast cells, the root cause of CSU, by inhibiting the KIT receptor, offering profound and durable benefits2, 5.

HAMPTON, N.J. – In a landmark presentation at the EAACI Congress 2025, Celldex (NASDAQ:CLDX) unveiled astonishing 76-week results for barzolvolimab, painting a future of lasting relief for those battling the torment of chronic spontaneous urticaria (CSU). This isn't just another treatment; it's a potential paradigm shift. Even seven months after completing their dosing regimen, an unprecedented 41% of patients experienced a complete disappearance of their debilitating hives and itch1.

For CSU sufferers, who often find little solace in existing therapies and face a relentless daily struggle8, barzolvolimab emerges as a beacon of hope. By ingeniously targeting the KIT receptor crucial for mast cell function – the very instigators of this immune-related condition – barzolvolimab has demonstrated a "profound, sustained complete response." Remarkably, 48% of patients reported their quality of life was no longer dictated by CSU at the 76-week mark. With a well-tolerated safety profile throughout the extensive study, these "best in disease data," as described by Celldex, signal a potential revolution for a condition that profoundly impacts lives. Celldex is now advancing barzolvolimab through global Phase 3 trials (EMBARQ-CSU1; NCT05638380 and EMBARQ-CSU2; NCT05638406). Further details on these results (late breaking oral presentation #100227) are available on the Celldex website.


References

  1. ir.celldex.com
  2. pubmed.ncbi.nlm.nih.gov
  3. ir.celldex.com
  4. onlinelibrary.wiley.com
  5. www.hcplive.com
  6. www.medcentral.com
  7. www.biospace.com
  8. www.pharmacytimes.com

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