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Anaphylaxis stories

Sep 22, 2026

Celldex barzolvolimab Phase 3 trials meet endpoints but report two anaphylaxis cases

Celldex Therapeutics' barzolvolimab achieved what analysts called best-in-class efficacy results in two Phase 3 trials for chronic spontaneous urticaria, meeting all primary and key secondary endpoints. However, the trials also reported two life-threatening anaphylaxis cases, causing shares to drop 13-15% despite the positive efficacy data.

Sep 22, 2026·6 sources
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Top claims

  • ▪Celldex Therapeutics Chief Executive Officer Anthony Marucci stated that the incidence of anaphylaxis was extremely low among approximately 2,400 patients treated with barzolvolimab overall.
  • ▪In the EMBARQ-CSU1 trial, the 150 mg dose of barzolvolimab showed a mean change in weekly urticaria activity score of -20.2 at Week 12 compared to -10.7 for placebo, while the 300 mg dose showed a mean change of -20.5.
  • ▪Among patients with baseline angioedema in the Phase 3 trials, 62.7% to 74.3% achieved complete resolution compared to approximately 33% on placebo.

Subtopics

Clinical trials1Drug Approval and Clinical Trials1Drug safety1

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