Celldex targets 2027 filing for barzolvolimab and drops prurigo nodularis trial

Celldex Therapeutics is concentrating its barzolvolimab effort on a single indication. It reported third-quarter results on 5 November 2026 with a cash balance of $650.3 million, down from $717.6 million at 30 June, a fall of $67.3 million. The company said it expects to file a Biologics License Application for the drug in chronic spontaneous urticaria (CSU) in 2027.

The filing plan rests on two Phase 3 trials, both called EMBARQ, which Celldex said hit every primary and key secondary goal. The company had announced that outcome in September. The material reviewed gives no efficacy or safety numbers and no detail on the doses tested, so the strength of the data package cannot yet be judged. Celldex has not given a more precise submission date than 2027.

Celldex is also ending a Phase 2 study of barzolvolimab in prurigo nodularis. No rationale was given in the information available. On the studies mentioned, the decision leaves CSU as the drug's only indication heading towards regulatory review. Celldex did not provide further financial detail in the material reviewed.

Context: CSU is already treated with biologic medicines, so any new entrant would be positioned against established options. How barzolvolimab might compare cannot be assessed until Celldex discloses its trial data.