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Insmed: ARIKAYCE ENCORE Phase 3 टॉपलाइन डेटा अब मार्च/अप्रैल 2026 में

The Phase 3 ENCORE study of ARIKAYCE in newly diagnosed or recurrent MAC lung disease has a new topline readout window of March or April 2026. Pending positive results, the company plans to file an sNDA for all MAC lung disease patients in the second half of 2026.

मुख्य तथ्य

फाइल किया गया
9 जन॰ 2026, 12:01 pm
घटना
टॉपलाइन परिणाम
दिशा
तटस्थ
कंपनी
INSMInsmed
संपत्ति
amikacin liposome inhalation suspension
स्रोत
SEC 8-K
विश्वसनीयता
स्रोत सहित
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

स्रोत का अंश

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