Registro de fonte primária
Nível de decisãoResultados topline
Celldex Reports Positive Phase 3 Topline for Barzolvolimab in CSU
Both EMBARQ-CSU1 and EMBARQ-CSU2 Phase 3 trials met the primary endpoint of statistically significant improvement in UAS7 at Week 12 for both 150 mg Q4W and 300 mg Q8W doses versus placebo, along with all key secondary endpoints including complete response (UAS7=0) rates that deepened through Week 24. Barzolvolimab also showed strong efficacy in omalizumab-refractory patients and those with severe angioedema. The trials continue to 52 weeks with BLA submission planned for 2027.
Fatos principais
- Arquivado
- 22 de set. de 2026, 11:09
- Evento
- Resultados topline
- Direção
- Positivo
- Empresa
CLDXCelldex- Ativo
- barzolvolimab
- Fonte
- SEC 8-K
- Confiança
- Com fonte
- Calendário
- Resultados de ensaio · 1 de out. de 2026 · Positivo
- UAS7=0 às 12s 150mg
- 42,4% / 45,7%
- UAS7=0 às 24s 150mg
- 49,0% / 54,0%
- UAS7=0 refratário a omalizumab
- 41,7-55,3%
- Alteração de UAS7 150mg Q4W vs placebo
- -20,2 vs -10,7 / -20,2 vs -11,4
Trecho da fonte
EX-99.1 2 tm2625892d1_ex99-1.htm EXHIBIT 99.1 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 transformational therapy in CSU · EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12 weeks across both studies and both dose groups · Clinically meaningful and statistically significant benefit demonstrated in omalizumab refractory CSU and patients with severe disease or severe angioedema · Efficacy sustained or deepened from weeks 12 to 24 · Well tolerated with a favorable safety profile through 24 weeks; consistent with prior studies · Tre
Mais sobre este ativo
14 de jun. de 2026
14:21
CLDXCelldexCelldex apresenta dados de longo prazo de barzolvolimab em angioedema na EAACI 2026