Celldex Pulls Barzolvolimab CSU Data to September

The Tip Desk · August 6, 2026 · 3 min read

Cash, cash equivalents and marketable securities were $717.6 million as of June 30, 2026, after $323.8 million of net proceeds from an April public offering.

Celldex Therapeutics (CLDX), an immunology company developing mast-cell–targeting antibodies, said it now expects topline results from its two Phase 3 barzolvolimab trials in chronic spontaneous urticaria in September or October 2026, earlier than the fourth-quarter window it had given two months ago, with a planned BLA filing still targeted for 2027.

The company also disclosed that a Phase 2 study of barzolvolimab in prurigo nodularis did not meet its primary or key secondary endpoints and that it is discontinuing that trial. Those two items framed a quarter in which the clinical calendar tightened and the balance sheet thickened after an April equity raise.

Enrollment in the global Phase 3 program, EMBARQ-CSU 1 and EMBARQ-CSU 2, had already been completed six months ahead of guidance, with 1,939 patients enrolled across 43 countries and more than 500 sites, including patients who remained symptomatic after advanced therapies. Topline data from those studies are anticipated in September or October 2026, supporting the planned 2027 BLA filing. A separate Phase 3 study in cold urticaria and symptomatic dermographism, started in December 2025, remained actively enrolling.

In June, the company presented long-term barzolvolimab data at the European Academy of Allergy and Clinical Immunology meeting showing sustained off-treatment improvement in chronic spontaneous urticaria, including up to 64% of patients who had angioedema at baseline remaining angioedema-free seven months after dosing ended. Enrollment is complete in a Phase 2 study in atopic dermatitis, with topline data expected in late 2026.

The prurigo nodularis readout, presented in July, was the opposite. Barzolvolimab was well tolerated and produced rapid suppression of circulating tryptase, but the trial did not meet its primary or key secondary endpoints. The company said the data suggest mast cells may not be the key pathogenic driver in that disease and that it is discontinuing the Phase 2 study.

On the bispecific platform, Phase 1 results for CDX-622 showed rapid, profound, dose-dependent reductions in serum tryptase and no dose-limiting toxicities. A Phase 1 proof-of-mechanism study in mild-to-moderate asthma is ongoing, and the company is advancing expansion into additional indications, including allergic rhinitis and food allergy.

Cash, cash equivalents and marketable securities were $717.6 million as of June 30, 2026, compared with $451.5 million as of March 31, 2026. The increase was primarily driven by $323.8 million of net proceeds from the April 2026 underwritten public offering, partially offset by $57.4 million of cash used in operating activities in the second quarter. Shares outstanding were 78.5 million. Celldex said that cash position is sufficient to meet estimated working capital requirements and fund current planned operations through 2028.

No material revenue was recognized in the second quarter of 2026, versus $0.7 million a year earlier, primarily due to a decrease in services under manufacturing and research and development agreements with Rockefeller University. Research and development expenses were $67.5 million, up from $54.2 million a year earlier, primarily due to higher barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount. General and administrative expenses were $13.1 million, up from $10.4 million a year earlier, primarily due to an increase in barzolvolimab commercial planning expenses.

Net loss was $73.5 million, or ($0.94) a share, for the second quarter of 2026, compared with a net loss of $56.6 million, or ($0.85) a share, a year earlier. Operating loss was $80.6 million. Investment and other income, net, was $7.1 million.

Co-founder, President and Chief Executive Officer Anthony Marucci said the company is looking forward to sharing topline results from the two Phase 3 barzolvolimab trials in the early fall and is actively driving toward potential commercialization.