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Celldex monoclonal antibody rebounds with pair of phase 3 wins for chronic skin condition

Published

22 September 2026

Topic

opportunities

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Biotech

◆ Geography

United States

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Read at fiercebiotech.com →

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Fusion42 · 22 September 2026 · Fusion42 review

Celldex's monoclonal antibody barzolvolimab achieved positive results in two phase 3 trials for treatment-refractory chronic spontaneous urticaria, meeting primary and secondary endpoints. The company plans to seek FDA approval in 2027 following these successful 52-week studies.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

You are seeing a path open to compete with Xolair in hard-to-treat chronic hives if you develop mast cell biology drugs. Launch preparations should start now to reposition against existing leaders.

◆ Coverage

1 source · 22 Sep 2026

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Biotechmonoclonal-antibodyphase-3clinical-trialschronic-urticariadrug-approval