Insmed: ARIKAYCE ENCORE Phase 3 Topline jetzt März/April 2026

Die Phase-3-ENCORE-Studie von ARIKAYCE bei neu diagnostizierter oder rezidivierender MAC-Lungenerkrankung hat ein neues Topline-Lesezeitfenster von März oder April 2026. Bei positiven Ergebnissen plant das Unternehmen, im zweiten Halbjahr 2026 einen sNDA für alle MAC-Lungenerkrankungspatienten einzureichen.

Kernfakten

Eingereicht: 9. Jan. 2026, 12:01
Ereignis: Topline-Ergebnisse
Richtung: Neutral
Unternehmen: IINSMInsmed
Asset: amikacin liposome inhalation suspension
Quelle: SEC 8-K
Belegstatus: Belegt
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

Auszug aus der Quelle

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