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Celldex plans 2027 BLA for barzolvolimab after positive Phase 3 urticaria results

🇺🇸 Celldex Therapeutics, Inc. (CLDX) · Thu 05 Nov 2026

Two Phase 3 EMBARQ studies in chronic spontaneous urticaria met all primary and key secondary endpoints, while the company drops its Phase 2 prurigo nodularis study.

Celldex Therapeutics said on 5 November 2026, alongside its third-quarter results, that it expects to submit a Biologics License Application (BLA) for barzolvolimab in 2027. The planned filing is for chronic spontaneous urticaria (CSU).

The company reported that two Phase 3 EMBARQ studies of barzolvolimab in CSU met all primary and key secondary endpoints. Celldex said the results were announced in September. The summary available does not provide efficacy figures, safety data or details of the dosing regimens tested.

Celldex is discontinuing its Phase 2 study of barzolvolimab in prurigo nodularis. No reason for the decision is given in the information available.

On the financial side, Celldex reported cash of $650.3 million, down from $717.6 million at 30 June 2026. The company did not provide further detail in the material reviewed.

What it means for your team

  • Regulatory teams tracking CSU should note the 2027 BLA target; the exact timing and the data package have not yet been specified.
  • Market-access teams may want to begin horizon scanning for barzolvolimab as a potential new entrant in CSU, bearing in mind that no approval has been sought yet.
  • The end of the prurigo nodularis programme narrows the near-term indication scope for barzolvolimab to CSU, at least among the studies mentioned.

Company's press release (SEC filing): Celldex Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Celldex Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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