---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-23-042505"
form_type: "8-K"
ticker: "INSM"
cik: "0001104506"
company_name: "INSMED Inc"
filed_at: "2023-09-05T23:59:59+00:00"
generated_at: "2026-06-10T23:45:02.921373+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Insmed Phase 3 ARISE study meets primary endpoint; ARIKAYCE shows strong culture conversion in MAC lung disease

## Summary
- ARISE validated QOL-B respiratory domain as PRO tool; to be proposed as primary endpoint for ENCORE without modification.
- ARIKAYCE arm achieved 78.8% culture conversion at Month 7 vs 47.1% for comparator (p=0.0010).
- QOL-B respiratory score improvement trend: 12.24 vs 7.76 (p=0.1073); 43.8% of ARIKAYCE patients exceeded meaningful threshold.
- No new safety signals; discontinuation rate 22.9% for ARIKAYCE vs 7.8% for comparator.
- Insmed plans to explore accelerated filing for ARIKAYCE in newly infected MAC patients with global regulators.

## SEC filing metadata
- accession: 0001140361-23-042505
- form_type: 8-K
- ticker: INSM
- cik: 0001104506
- company_name: INSMED Inc
- filed_at: 2023-09-05T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1104506/000114036123042505/0001140361-23-042505-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1104506/000114036123042505/brhc20058439_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-23-042505
- JSON: https://secwatch.observer/filing/0001140361-23-042505.json
- Plain text: https://secwatch.observer/filing/0001140361-23-042505.txt

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