---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-005570"
form_type: "8-K"
ticker: "INSM"
cik: "0001104506"
company_name: "INSMED Inc"
filed_at: "2025-02-24T23:59:59+00:00"
generated_at: "2026-05-26T05:26:59.518754+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001140361-25-005570
- form_type: 8-K
- ticker: INSM
- cik: 0001104506
- company_name: INSMED Inc
- filed_at: 2025-02-24T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1104506/000114036125005570/0001140361-25-005570-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1104506/000114036125005570/ef20044166_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-005570
- JSON: https://secwatch.observer/filing/0001140361-25-005570.json
- Plain text: https://secwatch.observer/filing/0001140361-25-005570.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.