Celldex Therapeutics presented data at the 2026 American Academy of Allergy, Asthma & Immunology Annual Meeting showing that retreatment with barzolvolimab produced complete response rates comparable to those seen during initial exposure in patients with cold urticaria (ColdU) and symptomatic dermographism (SD).
In the Phase 2 ColdU/SD Open Label Extension, 121 patients entered the study—61 with ColdU and 60 with SD—and 116 completed treatment. At week 20, 62 % of ColdU patients and 60 % of SD patients achieved a complete response, matching the 66 % and 49 % rates observed during the main 20‑week study. For patients who had responded initially, retreatment yielded 82 % and 86 % complete responses in ColdU and SD, respectively, underscoring the drug’s ability to re‑engage mast‑cell depletion safely and effectively.
The findings support barzolvolimab’s potential as a best‑in‑class therapy for chronic urticarias and suggest that intermittent dosing could align with real‑world treatment patterns, potentially improving patient adherence and commercial viability.
"Patients and physicians need treatment options that provide durable, symptom‑free complete response and the potential for flexibility that reflects real‑world treatment paradigms," said Diane Young, MD, Senior Vice President and Chief Medical Officer. "The retreatment data demonstrate that when disease symptoms recur, patients can be retreated and achieve the same high levels of complete response again, supporting barzolvolimab’s profile as a best‑in‑class, best‑in‑disease potential treatment option," added Anthony Marucci, CEO.
Celldex’s financial performance in 2025 reflected a decline in revenue to $1.5 million from $7.0 million in 2024, largely driven by reduced services under agreements with Rockefeller University. Net loss widened to $258.8 million ($3.90 per share) from $157.9 million ($2.45 per share) in 2024, while R&D expenses rose to $245.1 million from $163.6 million, reflecting increased investment in barzolvolimab clinical trials and contract manufacturing. The company reported $518.6 million in cash, cash equivalents and marketable securities as of December 31 2025, providing a runway through 2027.
Investors responded enthusiastically to the data presented at the AAAAI, reflecting confidence in barzolvolimab’s development and Celldex’s broader pipeline strategy.
Celldex continues to advance barzolvolimab through its Phase 3 EMBARQ‑ColdU and EMBARQ‑SD programs, with topline data expected in Q4 2026 and a BLA submission planned for 2027. The company’s ongoing Phase 2 studies in prurigo nodularis and atopic dermatitis, along with a Phase 1 asthma program, further diversify its portfolio and reinforce its focus on mast‑cell‑mediated diseases.
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