---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-001099"
form_type: "8-K"
ticker: "MIST"
cik: "0001408443"
company_name: "Milestone Pharmaceuticals Inc."
filed_at: "2026-01-06T23:59:59+00:00"
generated_at: "2026-05-16T11:30:50.154424+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Milestone Pharma announces EMA acceptance of MAA for etripamil in PSVT; decision expected Q1 2027

## Summary
- EMA accepted Marketing Authorization Application for etripamil nasal spray (TACHYMIST) for PSVT; decision expected Q1 2027.
- Phase 3 RAPID trial: 64% conversion to sinus rhythm at 30 min vs 31% placebo (p<0.001); median time 17 min vs 54 min.
- Drug is conditionally approved brand name TACHYMIST in Europe; ~2 million PSVT patients in Europe.
- MAA includes global clinical data that supported U.S. FDA approval of etripamil for PSVT.

## SEC filing metadata
- accession: 0001104659-26-001099
- form_type: 8-K
- ticker: MIST
- cik: 0001408443
- company_name: Milestone Pharmaceuticals Inc.
- filed_at: 2026-01-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1408443/000110465926001099/0001104659-26-001099-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1408443/000110465926001099/tm261989d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-001099
- JSON: https://secwatch.observer/filing/0001104659-26-001099.json
- Plain text: https://secwatch.observer/filing/0001104659-26-001099.txt

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