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Monday, March 23, 2026

Insmed’s ARIKAYCE Phase 3b ENCORE trial in lung disease positive topline results, FDA post‑marketing

 

Insmed’s ARIKAYCE Phase 3b ENCORE trial in treatment‑naïve MAC lung disease shows positive topline results, fulfilling FDA post‑marketing requirement

  • Results support plans to file U.S. sNDA for ARIKAYCE label expansion and traditional approval in the second half of 2026.
  • Insmed plans to submit an ARIKAYCE label expansion application in Japan in the second half of 2026.
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