Celldex Therapeutics, Inc. (CLDX): Other Events

Celldex Therapeutics (CLDX) shares rose 8% after reporting positive Phase 3 trial results for barzolvolimab in treating chronic spontaneous urticaria (CSU). Both trials met primary and secondary endpoints, showing significant improvements in disease activity. The 150 mg and 300 mg doses outperformed placebos, with complete response rates of 42.4%-54.0% versus 9.3%-12.6%. The drug was well-tolerated, and Celldex plans an FDA submission in 2027.

Celldex Therapeutics, Inc. (CLDX) filed an SEC Form 8-K — Results of Operations and Financial Condition. EXHIBIT 99.1 Celldex Reports Second Quarter Financial Results and Provides Corporate Update Barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2) ongoing, topline data expected in Sept/Oct 2026; BLA submission planned for 2027 Phase 3 barzolvolimab cold

Biotech weekly roundup highlights EU approval for AstraZeneca’s Etcamah plus CDK4/6 inhibitors in ESR1-mutant ER+/HER2- advanced breast cancer, and accelerated FDA approval for GSK’s Jideytro in ROS1+ NSCLC. J&J received FDA De Novo for OTTAVA and reported Phase 3 PFS/OS gains for Talvey combos. Other items include deals (RGEN-BioLife, RPRX royalty buy) and trial updates for LLY, CLDX, and others.

Celldex Therapeutics said its 24-week, double-blind, placebo-controlled prurigo nodularis trial of barzolvolimab (140 patients) failed to meet the primary 12-week itch improvement endpoint and key secondary lesion outcomes. Mast cell depletion via reduced tryptase occurred, but symptoms did not improve. Celldex also previously halted EoE development. CLDX shares were down 6.06% premarket at $33.50.

Celldex said its subcutaneous monoclonal antibody barzolvolimab failed in a Phase II randomized, double-blind, placebo-controlled trial in prurigo nodularis (NCT06366750). Patients did not achieve significant improvement on the WI-NRS at week 12 versus placebo, and key secondary endpoints also missed. Celldex is discontinuing the PN Phase II study; stock was expected to fall at the open.

Celldex (CLDX) reported topline Phase 2 results for barzolvolimab in prurigo nodularis, saying the study did not meet the primary WI-NRS Week 12 endpoint or key secondary endpoints at either dose. Celldex will discontinue the PN Phase 2 trial and cited prior safety/tolerability. CLDX fell in after-hours.