Celldex Meets CSU Endpoints, Plans 2027 BLA

The Tip Desk · November 7, 2026 · 3 min read

Cash, cash equivalents and marketable securities stood at $650.3 million as of September 30, 2026, after $65.0 million of cash used in operating activities in the third quarter.

Celldex Therapeutics (CLDX) reported that its two Phase 3 studies of barzolvolimab in chronic spontaneous urticaria met their primary and key secondary endpoints, and that it anticipates a Biologics License Application in 2027.

The immunology company said the EMBARQ-CSU1 and EMBARQ-CSU2 topline results, released in September 2026, showed rapid, profound and sustained efficacy in patients whose symptoms were inadequately controlled by H1-antihistamines, including unprecedented complete response rates. Efficacy was sustained or deepened from Weeks 12 to 24, and the antibody was well-tolerated through 24 weeks. Statistically significant and clinically meaningful benefit was also seen in antihistamine-refractory patients with severe disease or severe angioedema, and in patients refractory to omalizumab. Treatment in both trials will continue to 52 weeks.

Co-founder, President and Chief Executive Officer Anthony Marucci said barzolvolimab has significant potential to shift the treatment goal from symptom improvement to complete symptom resolution.

The company said the Phase 3 data are consistent with a completed Phase 2 CSU study in which patients received barzolvolimab for 52 weeks. At 76 weeks, seven months after dosing ended, more than 40% of patients on 150 mg every four weeks continued to experience profound, sustained complete response, and up to 64% of patients who had angioedema at baseline remained angioedema-free.

Enrollment is ongoing in the global Phase 3 EMBARQ-ColdU and -SD study in cold urticaria and symptomatic dermographism. Celldex said barzolvolimab is the first drug in development to demonstrate clinical benefit in those conditions in a large, randomized, placebo-controlled study, and that it looks forward to updating on those programs in 2027.

Enrollment is complete in a Phase 2 study of barzolvolimab in moderate to severe atopic dermatitis; topline data are expected in late 2026. Topline data from a Phase 2 study in prurigo nodularis presented in July 2026 suggested mast cells may not be the key pathogenic driver in that disease. Celldex is discontinuing the Phase 2 prurigo nodularis study. Additional indications for barzolvolimab will be announced by year end.

CDX-622, a bispecific antibody that neutralizes TSLP and depletes mast cells via SCF starvation, remains in a Phase 1 proof-of-mechanism study in mild to moderate asthma. The company plans to advance expansion into additional indications, including allergic rhinitis and food allergy.

Cash, cash equivalents and marketable securities were $650.3 million as of September 30, 2026, compared with $717.6 million as of June 30, 2026. The company said the decrease was primarily driven by $65.0 million of cash used in operating activities in the third quarter. Celldex believes that cash is sufficient to meet estimated working capital requirements and fund current planned operations through 2028. Shares outstanding were 78.5 million.

No material revenue was recognized in the third quarter of 2026, versus $0.0 million in the third quarter of 2025. The company attributed the decline to fewer services under manufacturing and research and development agreements with Rockefeller University.

Research and development expenses were $67.4 million in the third quarter of 2026, compared with $62.9 million a year earlier. The company said the increase was primarily due to higher barzolvolimab clinical-trial and contract-manufacturing expense and added headcount to support development. General and administrative expenses were $14.8 million, compared with $10.7 million a year earlier, which the company said reflected higher barzolvolimab commercial-planning costs and commercialization headcount.

Net loss was $75.6 million, or $0.96 a share, for the third quarter of 2026, compared with a net loss of $67.0 million, or $1.01 a share, a year earlier. Basic and diluted shares used in the per-share calculation were 78.5 million.