Insmed: ARIKAYCE ENCORE Fase 3 dados principais agora em março/abril de 2026

O estudo ENCORE de Fase 3 do ARIKAYCE em doença pulmonar por MAC recém-diagnosticada ou recorrente tem uma nova janela de divulgação dos dados principais em março ou abril de 2026. Pendentes resultados positivos, a empresa planeja submeter uma sNDA para todos os pacientes com doença pulmonar por MAC no segundo semestre de 2026.

Fatos principais

Arquivado: 9 de jan. de 2026, 12:01
Evento: Resultados topline
Direção: Neutro
Empresa: IINSMInsmed
Ativo: amikacin liposome inhalation suspension
Fonte: SEC 8-K
Confiança: Com fonte
respiratory symptom score: 17.77 vs 14.66 points, p=0.0299
culture conversion month 6: 87.8% vs 57.0%, p<0.0001
culture conversion month 12: 84.7% vs 61.3%, p<0.0001
culture conversion month 13: 82.4% vs 55.6%, p<0.0001
durable culture conversion month 15: 76.2% vs 47.6%, p<0.0001

Trecho da fonte

EX-99.1 2 ef20062540_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Insmed Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference — BRINSUPRI ® (brensocatib) Unaudited Total Revenues of Approximately $144.6 Million for First Full Quarter of Launch; Approximately $172.7 Million for Full-Year 2025— —ARIKAYCE ® (amikacin liposome inhalation suspension) Exceeds the Upper End of Guidance Range for Full-Year 2025 with Unaudited Global Revenues of Approximately $433.8 Million— —Full-Year 2026 Global ARIKAYCE Revenues Expected to be Between $450 Million and $470 Million— —Topline Data from Phase 3 ENCORE Study of ARIKAYCE in Patients with Newly Diagnosed or Recurrent MAC Lung Disease Now Anticipated in March or April of 2026— — Topline Data from Phase 2b CEDAR Study of Brensocatib

SEC 8-K