Celldex stock falls after hives trial data (CLDX:NASDAQ)

Celldex Therapeutics (CLDX) stock fell 37% in pre-market trading after positive Phase 3 trial results for barzolvolimab, a 'sell the news' reaction. The trials met primary and secondary endpoints, but investors were disappointed, as the stock had rallied ahead of the announcement. The company's Phase 2 study failure and delayed BLA submission also contributed to the decline. The broader market showed little impact, indicating the drop was company-specific.

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 — Other Events. Exhibit 99.1 Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints · Best-in-disease results showed rapid, profound, sustained efficacy, supporting barzolvolimab’s potential to be a t

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.