Celldex: Phase 3 barzolvolimab trials in CSU met primary and key secondary endpoints
Celldex reported positive topline results from its two Phase 3 EMBARQ-CSU trials of barzolvolimab in chronic spontaneous urticaria, with both trials meeting the primary endpoint and all key secondary endpoints at Week 12. The company plans to submit a Biologics License Application to the FDA in 2027, and treatment in both trials will continue to 52 weeks. The filing contains no financial results, so the near-term effect on shareholders depends on the regulatory timeline.
Key points
- EMBARQ-CSU1 and EMBARQ-CSU2 both met the primary endpoint (mean change in UAS7 at Week 12) and all key secondary endpoints across both dose groups.
- Complete response (UAS7=0) at Week 12 was 42.1% to 45.7% on barzolvolimab versus 9.3% to 12.6% on placebo.
- 1,939 patients were randomized; data cutoff was September 9, 2026.
- BLA submission to the FDA is planned for 2027.
The filing
Written by AI on Nov 9, 2026, 8:51 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 22, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.