FDA will not hold AdComm for Insmed's brensocatib; PDUFA date Aug 12, 2025

INSMED Inc

FDA communicated in Day 74 letter no advisory committee meeting is currently planned.
Priority review reaffirmed with PDUFA target action date of August 12, 2025.
NDA for non-CF bronchiectasis is based on data from the Phase 3 ASPEN study.
Brensocatib could be the first approved treatment for bronchiectasis and first DPP1 inhibitor.

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