---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-105052"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2026-09-03T20:03:58+00:00"
generated_at: "2026-09-03T20:05:10.902986+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Milestone's etripamil approved in China by NMPA; first approval outside US

## Summary
- NMPA approved etripamil nasal spray for PSVT in adults on Sept 3, 2026; first approval outside US.
- Approval triggers $2.0M milestone payment to Milestone; Everest Medicines to commercialize in Greater China.
- Milestone eligible for up to $98.0M in milestones and tiered royalties up to 18% on future sales.
- Based on Phase 3 RAPID and JX02002; JX02002 showed HR=3.002 (95% CI 1.578-5.711, p=0.0005) for conversion to sinus rhythm.
- No serious adverse events reported within 24 hours after dosing across Phase 3 studies.

## SEC filing metadata
- accession: 0001104659-26-105052
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2026-09-03T20:03:58+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465926105052/0001104659-26-105052-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465926105052/tm2624766d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-105052
- JSON: https://secwatch.observer/filing/0001104659-26-105052.json
- Plain text: https://secwatch.observer/filing/0001104659-26-105052.txt

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