Exhibit 99.1 Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints Best-in-disease results showed rapid, profound, sustained efficacy, supporting barzolvolimab’s potential to be a transformational therapy in CSU EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12 weeks across both studies and both dose groups Clinically meaningful and statistically significant benefit demonstrated in omalizumab refractory CSU and patients with severe disease or severe angioedema Efficacy sustained or deepened from weeks 12 to 24 Well tolerated with a favorable safety profile through 24 weeks; consistent with prior studies Treatment will continue in both trials to 52 weeks; BLA submission anticipated in 2027 Company to host webcast today at 8:00 am ET HAMPTON, N.J., September 22, 2026 -- Celldex (NASDAQ:CLDX) today reported positive topline results from the Company’s Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials evaluating two doses of barzolvolimab in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antih…
Open exhibit ↗Current Report · Items 8.01, 9.01 · 8-K
Celldex Therapeutics, Inc.
CLDXNASDAQEQUITYCurrent
Other Events
Item 8.01. Other Events. On September 22, 2026, Celldex Therapeutics, Inc. issued a press release announcing results from its two Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of Barzolvolimab in chronic spontaneous urticaria (CSU). A copy of this press release is attached hereto as Exhibit 99.1 hereto and is incorporated by reference herein.
Company context
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com.
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Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01. Other Events.
On September 22, 2026, Celldex Therapeutics, Inc. issued a press release
announcing results from its two Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of Barzolvolimab in chronic spontaneous urticaria (CSU). A
copy of this press release is attached hereto as Exhibit 99.1 hereto and is incorporated by reference herein.