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Celldex Therapeutics, Inc. (CLDX) filed an 8-K current report with the SEC on September 22, 2026 reporting Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 results announced for barzolvolimab in chronic spontaneous urticaria.
Celldex Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 8.01 · Other Events
- Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 results announced for barzolvolimab in chronic spontaneous urticaria
- Clinical readout is material to barzolvolimab’s regulatory path and Celldex’s commercial prospects
- Full efficacy, safety, and trial results in Exhibit 99.1
Item EX-99.1 · Exhibit EX-99.1
- Phase 3 EMBARQ-CSU1 and CSU2 met primary and all key secondary endpoints, materially reducing barzolvolimab’s clinical risk
- Complete response at Week 24 reached 49.0%-54.0% versus 15.4%-17.6% for placebo, supporting competitive differentiation
- Benefits extended to omalizumab-refractory patients and those with angioedema, expanding potential addressable CSU populations
- Favorable safety profile through 24 weeks, with treatment continuing to Week 52
- BLA submission planned for 2027, advancing Celldex toward potential commercial-stage operations and future launch costs
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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