Celldex reports Q3 2026 results, confirms 2027 BLA plan for barzolvolimab in CSU
Celldex says Phase 3 CSU trials met all endpoints and the enrolling cold urticaria study continues, with cash of $650.3 million seen funding operations into 2028.
Celldex Therapeutics reported third quarter 2026 financial results and a pipeline update on November 5, 2026. In September 2026, the company reported topline results from the Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies of barzolvolimab in patients with chronic spontaneous urticaria whose symptoms are not adequately controlled by H1-antihistamines, with the primary and all key secondary endpoints met across both studies and both dose groups.1 Efficacy was sustained or deepened from Weeks 12 to 24, and barzolvolimab was well tolerated with a favorable safety profile through 24 weeks, consistent with prior studies.1 Treatment in both EMBARQ-CSU trials will continue to 52 weeks, and the company anticipates a BLA submission in 2027.1
Enrollment is ongoing in Celldex's global Phase 3 study in cold urticaria and symptomatic dermographism, called EMBARQ-ColdU and -SD.1 In other pipeline news, enrollment is complete in the Phase 2 study of barzolvolimab in atopic dermatitis, with topline data expected in late 2026.1 Topline data from the Phase 2 prurigo nodularis study, presented in July 2026, suggested mast cells may not be the key pathogenic driver in that disease, and Celldex is discontinuing the Phase 2 PN study.1 A Phase 1 proof-of-mechanism study of the bispecific candidate CDX-622 is ongoing in adults with mild to moderate asthma.1
On financials, cash, cash equivalents and marketable securities were $650.3 million as of September 30, 2026, down from $717.6 million at June 30, 2026, driven by third quarter operating cash use of $65.0 million.1 Research and development expenses were $67.4 million for the quarter and $208.0 million for the nine months ended September 30, 2026, versus $62.9 million and $169.7 million in the comparable 2025 periods.1 Net loss was $75.6 million, or $0.96 per share, for the quarter, and $227.7 million, or $3.06 per share, for the nine months.1 The company said it believes its cash position is sufficient to fund current planned operations through 2028.1
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