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Celldex Reports Third Quarter Financial Results and Provides Corporate Update

Globe Newswire•05/11/2026•16:01 ET
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Key Highlights

  • ➤Phase 3 CSU studies met all primary and key secondary endpoints
  • ➤BLA submission for barzolvolimab in CSU anticipated in 2027
  • ➤Cash, equivalents and marketable securities totaled $650.3 million
  • ➤Q3 net loss widened to $75.6 million, or $0.96 per share
  • ➤Cash position expected to fund planned operations through 2028

Expert Statements

Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex

“Barzolvolimab has significant potential to address enormous populations of high unmet need and shift the treatment paradigm goal from symptom improvement to complete symptom resolution, which for patients means no itch, no hives, no swelling”

Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex

“This quarter we reported best-in-disease results from our two Phase 3 studies in CSU, demonstrating barzolvolimab’s unparalleled ability to deliver complete response to patients—including even in patient populations suffering with severe disease or severe angioedema or with omalizumab refractory disease.”

Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex

“We are moving quickly to bring this much needed medicine to patients and physicians.”

Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex

“We are also making excellent progress advancing our ongoing Phase 3 study in symptomatic dermographism and cold urticaria and look forward to updating on these programs in 2027.”

Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex

“Building on our leading science clinically validating the therapeutic potential of KIT inhibition in immune and inflammatory diseases, we will continue to chart the future of mast cell medicine, expanding barzolvolimab and CDX-622 development across a diverse spectrum of immune and inflammatory diseases and adding to our growing mast cell targeted pipeline to bring our science to additional patient populations that could benefit.”

* Best-in-disease results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies showed rapid, profound, sustained efficacy supporting barzolvolimab’s potential to be a transformational therapy in CSU * BLA submission for barzolvolimab in CSU anticipated in 2027 * Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling * Excellent progress across all earlier stage pipeline programs HAMPTON, N.J., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2026 and provided a corporate update.

“Barzolvolimab has significant potential to address enormous populations of high unmet need and shift the treatment paradigm goal from symptom improvement to complete symptom resolution, which for patients means no itch, no hives, no swelling,” said Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex. “This quarter we reported best-in-disease results from our two Phase 3 studies in CSU, demonstrating barzolvolimab’s unparalleled ability to deliver complete response to patients—including even in patient populations suffering with severe disease or severe angioedema or with omalizumab refractory disease. We are moving quickly to bring this much needed medicine to patients and physicians. We are also making excellent progress advancing our ongoing Phase 3 study in symptomatic dermographism and cold urticaria and look forward to updating on these programs in 2027.

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