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CLDXBearishIndustry Newsnews

High materiality8/10

Celldex PN Phase 2 failure clouds barzolvolimab's CSU path

Jul 21, 2026, 4:05 PM EDT3 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Negative Phase 2 PN efficacy raises near-term downside for CLDX; however, CSU Phase 3 data could provide upside if results meet/exceed expectations, making the stock reaction data-dependent and data-driven.

AI summary

What happened, with direct paths to the underlying reporting

Celldex reported Phase 2 PN results for barzolvolimab did not meet the primary or key secondary endpoints, leading to PN discontinuation despite a favorable safety profile and robust mast cell depletion. Phase 3 CSU topline data remain on track for Sept/Oct 2026, with Phase 3 SD and ColdU enrollment continuing and Phase 2 AD data expected late 2026. The news adds near-term uncertainty for CLDX until CSU results.

PN Phase 2 failed primary and key secondary endpoints. PN study discontinued.
Profound mast cell depletion observed; tryptase reduction did not improve PN.
Phase 3 CSU topline data expected Sept/Oct 2026; SD and ColdU enrollment on track.
Phase 2 AD topline data expected late 2026.
Company to webcast today at 4:30 pm ET.

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Celldex PN Phase 2 failure clouds barzolvolimab's CSU path

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