Celldex announced positive long-term Phase 2 results for barzolvolimab in chronic spontaneous urticaria (CSU), showing that up to 64% of patients remained angioedema-free seven months after treatment completion. The drug demonstrated rapid, significant, and durable improvements in angioedema symptoms, with potential to shift CSU treatment from symptom control to disease modification. Two Phase 3 trials enrolling 1,939 patients are ongoing with topline data expected in Q4 2026.

Celldex announced positive Phase 1 results for CDX-622, a novel bispecific antibody targeting soluble SCF and TSLP for inflammatory diseases. The drug demonstrated rapid, dose-dependent reductions in serum tryptase indicative of mast cell depletion and was well-tolerated at all dose levels. CDX-622 is now being studied in Phase 1b for mild to moderate asthma, with plans for additional proof-of-concept studies in allergic rhinitis and food allergy.

Celldex Therapeutics successfully closed an underwritten public offering of 11,896,750 shares of common stock at $29.00 per share, generating approximately $345 million in gross proceeds. The underwriters exercised their full option to purchase an additional 1,551,750 shares. The offering was managed by Leerink Partners, TD Cowen, Guggenheim Securities, and Cantor as joint bookrunning managers.

Celldex Therapeutics priced an underwritten public offering of 10.3 million shares at $29.00 per share, expecting to raise approximately $300 million in gross proceeds. The company plans to use the funds for commercial readiness and launch of barzolvolimab for CSU treatment, clinical development of product candidates, and expansion of its bispecific antibody platform.

Celldex presented Phase 2 data showing barzolvolimab retreatment achieves similar efficacy to initial treatment in cold urticaria and symptomatic dermographism patients, with 62% and 60% complete response rates respectively. The data supports an intermittent treatment paradigm and barzolvolimab's profile as a first-in-class therapy. Phase 3 trials (EMBARQ-ColdU and SD) are currently enrolling patients.

Celldex presented positive Phase 2 data for barzolvolimab, a novel mast cell-targeting monoclonal antibody, showing sustained off-treatment efficacy in chronic spontaneous urticaria (CSU) with 71% of patients achieving complete response after 52 weeks of treatment and 50% maintaining complete response 7 months post-treatment. The company also demonstrated improved quality of life and urticaria control in cold urticaria and symptomatic dermographism patients. Phase 3 enrollment in CSU was completed six months ahead of schedule with topline data expected in Q4 2026.

The global CIndU market is experiencing significant growth driven by advancements in diagnostic tools, biologic therapies, and increasing awareness of immune mechanisms, with emerging personalized medicine approaches promising improved patient outcomes.

Celldex's barzolvolimab demonstrated rapid, robust, and durable improvements in angioedema symptoms over 52 weeks in a Phase 2 study for chronic spontaneous urticaria, with up to 77% of patients being angioedema-free at Week 52.

Celldex Therapeutics presented positive preclinical data for its bispecific antibody CDX-622, which targets TSLP and SCF to reduce inflammation and fibrosis. The data showed CDX-622 inhibits TSLP and SCF-dependent activities, and a Phase 1 study in healthy volunteers is ongoing.

Celldex Therapeutics announced positive data from Phase 2 studies of its drug barzolvolimab in patients with chronic urticaria, demonstrating improved disease control and quality of life.

The chronic spontaneous urticaria market is expected to grow due to increased disease prevalence, improved diagnosis, and the launch of new therapies. Key companies working on innovative treatments include Novartis, Sanofi, Regeneron, Celldex Therapeutics, Jasper Therapeutics, and others.

Celldex Therapeutics has initiated a Phase 2 study of barzolvolimab, a mast cell depleting agent, for the treatment of moderate to severe atopic dermatitis. The study aims to evaluate the efficacy and safety of barzolvolimab in this patient population.