---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-030537"
form_type: "8-K"
ticker: "INSM"
cik: "0001104506"
company_name: "INSMED Inc"
filed_at: "2025-08-12T23:59:59+00:00"
generated_at: "2026-05-17T14:16:13.465697+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Insmed receives FDA approval for BRINSUPRI (brensocatib), first treatment for NCFB

## Summary
- FDA approved BRINSUPRI 10 mg and 25 mg for non-CF bronchiectasis in adults and children ≥12 years.
- Phase 3 ASPEN: 21.1% (10 mg) and 19.4% (25 mg) reduction in annual exacerbation rate vs placebo.
- Approximately 500,000 U.S. patients diagnosed with NCFB; first approved therapy for this condition.
- BRINSUPRI available by prescription via specialty pharmacy; commercial launches in EU/UK/Japan expected 2026.
- Insmed to host investor call today at 12:00 PM ET to discuss the approval.

## SEC filing metadata
- accession: 0001140361-25-030537
- form_type: 8-K
- ticker: INSM
- cik: 0001104506
- company_name: INSMED Inc
- filed_at: 2025-08-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1104506/000114036125030537/0001140361-25-030537-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1104506/000114036125030537/ef20053490_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-030537
- JSON: https://secwatch.observer/filing/0001140361-25-030537.json
- Plain text: https://secwatch.observer/filing/0001140361-25-030537.txt

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